Download PDF

Clinical Trial Results:
Anti-platelet Therapy in the Primary Prevention of Cardiovascular Disease in Patients with Chronic Obstructive Pulmonary Disease.

Summary
EudraCT number	2014-005475-86
Trial protocol	GB
Global end of trial date	10 Nov 2017

Results information
Results version number	v1(current)
This version publication date	29 Mar 2019
First version publication date	29 Mar 2019
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

7356

ISRCTN number

ISRCTN43245574

US NCT number

NCT03487406

WHO universal trial number (UTN)

Sponsor organisation name

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor organisation address

Level 1, Regent Point, Gosforth, Newcastle upon Tyne, United Kingdom, NE3 3HD

Public contact

Newcastle Clinical Trials Unit, Newcastle University, 44 (0)191 2083820 ,

Scientific contact

Newcastle Clinical Trials Unit, Newcastle University, 44 (0)191 2083820 ,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

18 May 2018

Is this the analysis of the primary completion data?

Yes

Primary completion date

10 Nov 2017

Global end of trial reached?

Yes

Global end of trial date

10 Nov 2017

Was the trial ended prematurely?

Main objective of the trial

To establish if treatment with blood thinning medications such as Aspirin and Ticagrelor in patients with a lung condition called chronic obstructive pulmonary disease (COPD) who are predicted to be at an increased risk of heart disease or heart attacks, will affect the function of the blood cells called platelets. This will be measured using a bedside Multiplate platelet function test.

Protection of trial subjects

Follow-up of participants and 1, 3 and 6 months and collection of adverse events. A Trial Oversight Committee monitored efficacy and safety endpoints and had access to unblinded study data.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Jun 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 120

Worldwide total number of subjects

120

EEA total number of subjects

120

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Start date (open to recruitment): 4th September 2015. First randomisation: 4th November 2015. Last randomisation: 4th May 2017. Last patient completed 6 month visit: 1st November 2017. End of trial: 10th November 2017

Screening details

Participants eligible for screening into this study must have had a recorded clinical diagnosis of COPD as follows: 1. Abnormal spirometry with FEV1<80% and FEV1/FVC ratio <70% of predicted 2. Smoking history that is 10-pack years or greater (current or ex-smokers can be included) 3. Have capacity to consent.

Period 1 title

Baseline

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Blinding implementation details

For purposes of blinding, placebo to match Brilique (Ticagrelor) and Aspirin tablets were manufactured.

Are arms mutually exclusive

Yes

Aspirin

Arm description

Arm type

Experimental

Investigational medicinal product name

Aspirin

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

One 75mg tablet once daily

Investigational medicinal product name

Placebo (Ticagrelor)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

One tablet twice daily

Ticagrelor

Arm description

Arm type

Experimental

Investigational medicinal product name

Ticagrelor

Investigational medicinal product code

Other name

Brilique

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

90mg twice daily

Investigational medicinal product name

Placebo (Aspirin)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

One tablet daily

DAPT

Arm description

Dual Antiplatelet Therapy

Arm type

Experimental

Investigational medicinal product name

Aspirin

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

One 75mg tablet once daily

Investigational medicinal product name

Ticagrelor

Investigational medicinal product code

Other name

Brilique

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

90mg twice daily

Placebo

Arm description

Arm type

Placebo

Investigational medicinal product name

Placebo (Ticagrelor)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

One tablet twice daily

Investigational medicinal product name

Placebo (Aspirin)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

One tablet daily

Number of subjects in period 1	Aspirin	Ticagrelor	DAPT	Placebo
Started	31	29	29	31
Completed	31	29	29	31

Period 2 title

6 months

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

Aspirin

Arm description

Arm type

Experimental

Investigational medicinal product name

Aspirin

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

One 75mg tablet once daily

Investigational medicinal product name

Placebo (Ticagrelor)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

One tablet twice daily

Ticagrelor

Arm description

Arm type

Experimental

Investigational medicinal product name

Ticagrelor

Investigational medicinal product code

Other name

Brilique

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

90mg twice daily

Investigational medicinal product name

Placebo (Aspirin)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

One tablet daily

DAPT

Arm description

Arm type

Experimental

Investigational medicinal product name

Aspirin

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

One 75mg tablet once daily

Investigational medicinal product name

Ticagrelor

Investigational medicinal product code

Other name

Brilique

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

90mg twice daily

Placebo

Arm description

Arm type

Placebo

Investigational medicinal product name

Placebo (Ticagrelor)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

One tablet twice daily

Investigational medicinal product name

Placebo (Aspirin)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

One tablet daily

Number of subjects in period 2	Aspirin	Ticagrelor	DAPT	Placebo
Started	31	29	29	31
Completed	31	29	29	31

Baseline characteristics

Top of page

Reporting group title

Aspirin

Reporting group description

Reporting group title

Ticagrelor

Reporting group description

Reporting group title

DAPT

Reporting group description

Dual Antiplatelet Therapy

Reporting group title

Placebo

Reporting group description

Reporting group values	Aspirin	Ticagrelor	DAPT	Placebo	Total
Number of subjects	31	29	29	31	120
Age categorical
Units: Subjects
In utero					0
Preterm newborn infants (gestational age < 37 wks)					0
Newborns (0-27 days)					0
Infants and toddlers (28 days-23 months)					0
Children (2-11 years)					0
Adolescents (12-17 years)					0
Adults (18-64 years)					0
From 65-84 years					0
85 years and over					0
Age continuous
Age at randomisation
Units: years
arithmetic mean (standard deviation)	68.5 ± 7.2	66.5 ± 7.7	69.0 ± 10.6	66.3 ± 9.2	-
Gender categorical
Units: Subjects
Female	19	14	14	16	63
Male	12	15	15	15	57
Smoking status
Units: Subjects
Non-smoker	0	0	0	0	0
Ex-smoker	20	21	21	21	83
Light smoker (<10)	0	1	3	3	7
Moderate smoker (10-19)	9	5	4	5	23
Heavy smoker (20 or over)	2	2	1	2	7
Diabetes status
Units: Subjects
Type 1	0	2	3	0	5
Type 2	3	2	3	2	10
No diabetes	28	25	23	29	105
Angina or heart attack in a 1st degree relative <60?
Units: Subjects
Yes	6	7	9	10	32
No	25	22	20	21	88
On blood pressure treatment?
Units: Subjects
Yes	9	12	13	10	44
No	22	17	16	21	76
Rheumatoid arthritis?
Units: Subjects
Yes	1	3	1	0	5
No	30	26	28	31	115
COPD disease category*
*NICE Clinical Guideline (June 2010)
Units: Subjects
Severe (<30% FEV1 predicted)	6	6	5	8	25
Moderate (30-49% FEV1 predicted)	14	7	11	10	42
Mild (50-79% FEV1 predicted)	11	16	13	12	52
Not recorded	0	0	0	1	1
Daily sputum produced >3 months in each of last 2 years
Units: Subjects
Yes	15	18	15	22	70
No	16	11	14	9	50
SCRQ-C Current Health
Units: Subjects
Very good	0	0	0	2	2
Good	5	10	8	4	27
Fair	18	12	14	18	62
Poor	7	6	6	4	23
Very Poor	0	1	1	3	5
Missing	1	0	0	0	1
QRISK2 Score
Units: Scale Score
median (inter-quartile range (Q1-Q3))	19 (17 to 27)	22 (14 to 27)	24 (20 to 35)	20 (12 to 28)	-
Cholesterol/HDL ratio
Units: Ratio
median (inter-quartile range (Q1-Q3))	2.8 (2.4 to 4.1)	3.0 (2.6 to 3.6)	3.1 (2.4 to 3.6)	3.0 (2.2 to 4.0)	-
Systolic blood pressure
Units: mmHg
arithmetic mean (standard deviation)	144.6 ± 18.2	143.1 ± 14.7	144.5 ± 22.1	145.7 ± 16.1	-
Height
Units: cm
arithmetic mean (standard deviation)	163.0 ± 10.5	164.6 ± 11.3	166.9 ± 10.9	167.5 ± 9.9	-
Weight
Units: kg
arithmetic mean (standard deviation)	73.1 ± 17.4	72.2 ± 18.7	79.9 ± 18.5	74.7 ± 18.2	-
BMI
Units: Kg/m2
arithmetic mean (standard deviation)	27.4 ± 5.6	26.5 ± 5.7	28.9 ± 7.0	26.5 ± 5.4	-
Number of acute exacerbations of COPD treated in last 12 months
Units: Number
arithmetic mean (standard deviation)	3.4 ± 3.1	2.6 ± 3.1	2.5 ± 2.0	4.2 ± 4.5	-
Number of hospitalisations in last 12 months for COPD
Units: Number
arithmetic mean (standard deviation)	0.4 ± 1.6	0.4 ± 0.9	0.2 ± 1.0	0.6 ± 1.2	-
Haemoglobin
Units: G/100ml
arithmetic mean (standard deviation)	145.4 ± 14.5	146.1 ± 13.0	141.8 ± 16.6	146.4 ± 13.3	-
White blood cell count
Units: 10^9/L
arithmetic mean (standard deviation)	8.6 ± 2.3	8.8 ± 2.2	8.3 ± 1.9	8.6 ± 2.6	-
Platelet count
Units: 10^9/L
arithmetic mean (standard deviation)	280.6 ± 61.0	284.9 ± 65.7	281.6 ± 71.8	284.3 ± 77.2	-
Neutrophil count
Units: 10^9/L
arithmetic mean (standard deviation)	5.6 ± 2.0	5.6 ± 1.8	5.3 ± 1.8	5.7 ± 2.3	-
Monocytes
Units: 10^9/L
arithmetic mean (standard deviation)	0.64 ± 0.21	0.7 ± 0.19	0.67 ± 0.23	0.73 ± 0.42	-
Eosinophil count
Units: 10^9/L
arithmetic mean (standard deviation)	0.2 ± 0.15	0.18 ± 0.12	0.24 ± 0.19	0.24 ± 0.17	-
Urea
Units: mmol/L
arithmetic mean (standard deviation)	5.4 ± 2.1	5.0 ± 2.3	5.9 ± 1.8	4.7 ± 1.2	-
Creatinine
Units: umol/L
arithmetic mean (standard deviation)	71.4 ± 14.0	76.1 ± 20.0	86.9 ± 19.2	76.1 ± 14.9	-
Fibrinogen
Units: g/l
arithmetic mean (standard deviation)	3.7 ± 0.7	3.9 ± 0.8	3.7 ± 0.9	3.9 ± 0.8	-
hs CRP
Units: mg/l
arithmetic mean (standard deviation)	3.6 ± 3.5	8.2 ± 16.5	3.8 ± 3.8	7.8 ± 15.4	-
TNF alpha
Units: pg/ml
arithmetic mean (standard deviation)	2.35 ± 2.59	1.52 ± 1.23	1.44 ± 1.50	2.38 ± 2.73	-
IL6
Units: pg/ml
arithmetic mean (standard deviation)	5.96 ± 6.18	3.82 ± 3.04	3.39 ± 1.61	5.81 ± 5.64	-
MPO
Units: ng/ml
arithmetic mean (standard deviation)	1013.17 ± 578.5	785.53 ± 453.5	702.53 ± 324.3	814.38 ± 480.4	-
Vascular stiffness
Units: m/s
arithmetic mean (standard deviation)	9.91 ± 2.49	9.23 ± 1.23	9.87 ± 2.58	9.74 ± 1.90	-
CIMT maximum
Units: mm
arithmetic mean (standard deviation)	1.0 ± 0.3	1.0 ± 0.2	1.0 ± 0.2	1.0 ± 0.2	-
MRC dyspnoea scale
Scale score 1 - 5
Units: Scale score
arithmetic mean (standard deviation)	3.7 ± 1.1	3.4 ± 1.3	3.3 ± 1.2	3.6 ± 1.0	-
EQ5D 5L Index
Units: Scale score
arithmetic mean (standard deviation)	0.676 ± 0.222	0.662 ± 0.221	0.675 ± 0.253	0.619 ± 0.261	-
EQ5D Health Score
Units: Scale score
arithmetic mean (standard deviation)	59.3 ± 16.6	66.6 ± 18.1	60.9 ± 17.5	61.8 ± 20.4	-
SGRQ-C Symptom score
Units: Scale score
arithmetic mean (standard deviation)	72.3 ± 18.4	60.2 ± 24.8	67.3 ± 19.7	73.6 ± 22.2	-
SGRQ-C Activity score
Units: Scale score
arithmetic mean (standard deviation)	74.8 ± 24.6	67.7 ± 24.2	62.8 ± 30.8	74.2 ± 27.3	-
SGRQ-C Impact score
Units: Scale score
arithmetic mean (standard deviation)	42.5 ± 20.1	40.0 ± 25.2	42.2 ± 27.2	45.2 ± 26.7	-
SGRQ-C total
Units: Scale score
arithmetic mean (standard deviation)	57.7 ± 19.1	53.0 ± 21.8	53.0 ± 25.2	59.1 ± 23.9	-

End points

Top of page

Reporting group title

Aspirin

Reporting group description

Reporting group title

Ticagrelor

Reporting group description

Reporting group title

DAPT

Reporting group description

Dual Antiplatelet Therapy

Reporting group title

Placebo

Reporting group description

Reporting group title

Aspirin

Reporting group description

Reporting group title

Ticagrelor

Reporting group description

Reporting group title

DAPT

Reporting group description

Reporting group title

Placebo

Reporting group description

Subject analysis set title

Aspirin

Subject analysis set type

Intention-to-treat

Subject analysis set description

Descriptive statistics for the primary outcome of response for the comparative groups at baseline and 6 months for the ITT analysis set.

Subject analysis set title

No Aspirin

Subject analysis set type

Intention-to-treat

Subject analysis set description

Descriptive statistics for the primary outcome of response for the comparative groups at baseline and 6 months for the ITT analysis set.

Subject analysis set title

Ticagrelor

Subject analysis set type

Intention-to-treat

Subject analysis set description

Descriptive statistics for the primary outcome of response for the comparative groups at baseline and 6 months for the ITT analysis set.

Subject analysis set title

No Ticagrelor

Subject analysis set type

Intention-to-treat

Subject analysis set description

Descriptive statistics for the primary outcome of response for the comparative groups at baseline and 6 months for the ITT analysis set.

Subject analysis set title

Aspirin (PP)

Subject analysis set type

Per protocol

Subject analysis set description

Descriptive statistics for the primary outcome of response for the comparative groups at 6 months for the PP analysis set.

Subject analysis set title

No Aspirin (PP)

Subject analysis set type

Per protocol

Subject analysis set description

Descriptive statistics for the primary outcome of response for the comparative groups at 6 months for the PP analysis set.

Subject analysis set title

Ticagrelor (PP)

Subject analysis set type

Per protocol

Subject analysis set description

Descriptive statistics for the primary outcome of response for the comparative groups at 6 months for the PP analysis set.

Subject analysis set title

No Ticagrelor (PP)

Subject analysis set type

Per protocol

Subject analysis set description

Descriptive statistics for the primary outcome of response for the comparative groups at 6 months for the PP analysis set.

Primary: Response in platelet function (ITT analysis set)

Top of page

End point title

Response in platelet function (ITT analysis set) ^[1]

End point description

Inhibition of ASPI and adenosine diphosphate (ADP)-induced platelet aggregation at baseline, reported according to the 2x2 factorial comparative groups. Note that response is ASPI response in the Aspirin and No Aspirin columns and ADP response in the Ticagrelor and No Ticagrelor columns. Response is reported as a percentage with the 95% CI.

End point type

Primary

End point timeframe

Baseline

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This is a proof of concept study and the primary analysis is according to the Fleming A’Hern design. In the Aspirin group the number of responders (29) did not reach the critical threshold of 44 responders required to warrant further research. In the ticagrelor group, there were 24 ADP responders. This rate is lower than anticipated and did not reach the threshold to warrant further research.

End point values	Aspirin	No Aspirin	Ticagrelor	No Ticagrelor
Number of subjects analysed	60	60	58	62
Units: percent
number (confidence interval 95%)	1.7 (0.2 to 11.3)	10 (4.5 to 20.8)	6.9 (2.6 to 17.3)	1.6 (0.2 to 10.9)

No statistical analyses for this end point

Primary: Response in platelet function (ITT analysis set)

Top of page

End point title

Response in platelet function (ITT analysis set) ^[2]

End point description

Inhibition of ASPI and adenosine diphosphate (ADP)-induced platelet aggregation at 6-months, reported according to the 2x2 factorial comparative groups. Note that response is ASPI response in the Aspirin and No Aspirin columns and ADP response in the Ticagrelor and No Ticagrelor columns. Response is reported as a percentage with the 95% CI.

End point type

Primary

End point timeframe

6 months

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This is a proof of concept study and the primary analysis is descriptive.

End point values	Aspirin	No Aspirin	Ticagrelor	No Ticagrelor
Number of subjects analysed	60	60	58	62
Units: percent
number (confidence interval 95%)	48.3 (35.8 to 61)	11.7 (5.6 to 22.8)	41.4 (29.3 to 54.6)	3.2 (0.8 to 12.3)

No statistical analyses for this end point

Primary: Response in platelet function (PP analysis set)

Top of page

End point title

Response in platelet function (PP analysis set) ^[3]

End point description

Descriptive statistics for the primary outcome of response for the comparative groups at 6 months for the per protocol analysis set. Response is reported as a percentage with the 95% CI.

End point type

Primary

End point timeframe

6 months

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This is a proof of concept study and the primary analysis is descriptive.

End point values	Aspirin (PP)	No Aspirin (PP)	Ticagrelor (PP)	No Ticagrelor (PP)
Number of subjects analysed	41	45	32	54
Units: percent
number (confidence interval 95%)	68.3 (52.3 to 80.9)	15.6 (7.5 to 29.6)	68.8 (50.4 to 82.6)	3.7 (0.9 to 14.0)

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

1. All non-serious adverse reactions will be recorded at 6-month follow-up 2. Any serious adverse events will be recorded throughout the duration of the trial until 4 weeks after trial therapy is stopped

Assessment type

Systematic

Dictionary name

Study protocol

Dictionary version

5.0

Reporting group title

Aspirin

Reporting group description

Reporting group title

Ticagrelor

Reporting group description

Reporting group title

DAPT

Reporting group description

Reporting group title

Placebo

Reporting group description

Serious adverse events	Aspirin	Ticagrelor	DAPT	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	5 / 31 (16.13%)	5 / 29 (17.24%)	5 / 29 (17.24%)	6 / 31 (19.35%)
number of deaths (all causes)	0	1	0	1
number of deaths resulting from adverse events	0	0	0	0
Injury, poisoning and procedural complications
Fall/Head injury
subjects affected / exposed	0 / 31 (0.00%)	1 / 29 (3.45%)	0 / 29 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
atrial fibrillation with fast ventricular response
subjects affected / exposed	1 / 31 (3.23%)	0 / 29 (0.00%)	0 / 29 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Stable angina
subjects affected / exposed	0 / 31 (0.00%)	0 / 29 (0.00%)	1 / 29 (3.45%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Hysterectomy
subjects affected / exposed	1 / 31 (3.23%)	0 / 29 (0.00%)	0 / 29 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Perforation of sigmoid colon
subjects affected / exposed	0 / 31 (0.00%)	0 / 29 (0.00%)	0 / 29 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Upper GI bleed
subjects affected / exposed	1 / 31 (3.23%)	0 / 29 (0.00%)	0 / 29 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Exacerbation of Bronchiectasis
subjects affected / exposed	1 / 31 (3.23%)	0 / 29 (0.00%)	0 / 29 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Exacerbation of COPD
subjects affected / exposed	1 / 31 (3.23%)	2 / 29 (6.90%)	2 / 29 (6.90%)	4 / 31 (12.90%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infective exacerbation of COPD
subjects affected / exposed	0 / 31 (0.00%)	0 / 29 (0.00%)	0 / 29 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Left lower lobe collapse
Additional description: breathlessness
subjects affected / exposed	0 / 31 (0.00%)	1 / 29 (3.45%)	0 / 29 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 31 (3.23%)	1 / 29 (3.45%)	1 / 29 (3.45%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Pneumonia and pleurisy
subjects affected / exposed	0 / 31 (0.00%)	0 / 29 (0.00%)	1 / 29 (3.45%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Right sided pneumonia
subjects affected / exposed	0 / 31 (0.00%)	0 / 29 (0.00%)	0 / 29 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
Suspected lung malignancy
subjects affected / exposed	0 / 31 (0.00%)	0 / 29 (0.00%)	1 / 29 (3.45%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Urinary tract infection
subjects affected / exposed	0 / 31 (0.00%)	0 / 29 (0.00%)	1 / 29 (3.45%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Bilateral ankle fractures
subjects affected / exposed	0 / 31 (0.00%)	0 / 29 (0.00%)	0 / 29 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
fracture neck and left femur
subjects affected / exposed	0 / 31 (0.00%)	0 / 29 (0.00%)	0 / 29 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Aspirin	Ticagrelor	DAPT	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	17 / 31 (54.84%)	18 / 29 (62.07%)	21 / 29 (72.41%)	14 / 31 (45.16%)
Injury, poisoning and procedural complications
Fall - Rotator Cuff Injury
subjects affected / exposed	0 / 31 (0.00%)	0 / 29 (0.00%)	1 / 29 (3.45%)	0 / 31 (0.00%)
occurrences all number	0	0	1	0
General disorders and administration site conditions
Headache
subjects affected / exposed	0 / 31 (0.00%)	0 / 29 (0.00%)	1 / 29 (3.45%)	0 / 31 (0.00%)
occurrences all number	0	0	1	0
Insomnia
subjects affected / exposed	0 / 31 (0.00%)	0 / 29 (0.00%)	1 / 29 (3.45%)	0 / 31 (0.00%)
occurrences all number	0	0	1	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	0 / 31 (0.00%)	1 / 29 (3.45%)	0 / 29 (0.00%)	0 / 31 (0.00%)
occurrences all number	0	1	0	0
Respiratory, thoracic and mediastinal disorders
Exacerbation of COPD
subjects affected / exposed	14 / 31 (45.16%)	13 / 29 (44.83%)	5 / 29 (17.24%)	11 / 31 (35.48%)
occurrences all number	19	24	6	16
Exacerbation of Bronchiectasis
subjects affected / exposed	0 / 31 (0.00%)	0 / 29 (0.00%)	0 / 29 (0.00%)	1 / 31 (3.23%)
occurrences all number	0	0	0	2
Worsening breathlessness
subjects affected / exposed	1 / 31 (3.23%)	5 / 29 (17.24%)	4 / 29 (13.79%)	1 / 31 (3.23%)
occurrences all number	1	5	4	1
Skin and subcutaneous tissue disorders
Bruising
subjects affected / exposed	0 / 31 (0.00%)	4 / 29 (13.79%)	4 / 29 (13.79%)	1 / 31 (3.23%)
occurrences all number	0	4	6	1
Infections and infestations
Cellulitis
subjects affected / exposed	1 / 31 (3.23%)	0 / 29 (0.00%)	0 / 29 (0.00%)	0 / 31 (0.00%)
occurrences all number	1	0	0	0
Urinary tract infection
subjects affected / exposed	1 / 31 (3.23%)	1 / 29 (3.45%)	0 / 29 (0.00%)	1 / 31 (3.23%)
occurrences all number	1	1	0	1

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

08 Dec 2015

A change to the recruitment strategy, allowing PICs to help identify potentially eligible patients for study participation, along with minor amendments to the protocol and updated investigators brochure.

23 Jun 2016

This amendment concerned changes to the protocol, PIS and ICF in relation to broadening the eligibility criteria. This resulted in the randomisation of all eligible patients to receive treatment with the IMP and / or placebo regardless of their QRISK2 scores, removing the observational arm of the study. In addition as a result of the removal of the observational arm, the recruitment target was reduced from 240 to 120 patients.

17 Nov 2016

Removal of the QRISK2 score as a stratifying variable. Achange to the method of how SAEs will be reported to the funder. Extension of the originally planned end date from 01/12/2017 to 20/12/2018.

02 Oct 2017

This amendment was submitted in order to discontinue the 12 month follow-up, make administrative changes to the protocol, change the safety reporting, and inform of staffing changes.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Clinical trials

Clinical Trial Results:
Anti-platelet Therapy in the Primary Prevention of Cardiovascular Disease in Patients with Chronic Obstructive Pulmonary Disease.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Response in platelet function (ITT analysis set)

Primary: Response in platelet function (ITT analysis set)

Primary: Response in platelet function (ITT analysis set)

Primary: Response in platelet function (ITT analysis set)

Primary: Response in platelet function (PP analysis set)

Primary: Response in platelet function (PP analysis set)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: Anti-platelet Therapy in the Primary Prevention of Cardiovascular Disease in Patients with Chronic Obstructive Pulmonary Disease.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Response in platelet function (ITT analysis set)

Primary: Response in platelet function (ITT analysis set)

Primary: Response in platelet function (ITT analysis set)

Primary: Response in platelet function (ITT analysis set)

Primary: Response in platelet function (PP analysis set)

Primary: Response in platelet function (PP analysis set)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Anti-platelet Therapy in the Primary Prevention of Cardiovascular Disease in Patients with Chronic Obstructive Pulmonary Disease.