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Clinical Trial Results:
Short-term endothelin A receptor blockade in patients with on-pump coronary artery bypass grafting

Summary
EudraCT number	2010-023552-90
Trial protocol	AT
Global end of trial date	15 Oct 2015

Results information
Results version number	v1(current)
This version publication date	06 Aug 2020
First version publication date	06 Aug 2020
Other versions

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

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Trial information

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Sponsor protocol code

BQ123CPBP17022012

ISRCTN number

US NCT number

NCT01658410

WHO universal trial number (UTN)

Sponsor organisation name

Medical University of Vienna

Sponsor organisation address

Spitalgasse 23, Vienna, Austria, 1090

Public contact

Prof. Dr. Martin Andreas, Medical University of Vienna, +43 14040069660, martin.andreas@meduniwien.ac.at

Scientific contact

Prof. Dr. Martin Andreas, Medical University of Vienna, +43 14040069660, martin.andreas@meduniwien.ac.at

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

24 Jun 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

15 Oct 2015

Global end of trial reached?

Yes

Global end of trial date

15 Oct 2015

Was the trial ended prematurely?

Yes

Main objective of the trial

The main objective of the trial was to assess the effect of BQ-123 on enzymatic infarct size (CK-MB area under the curve).

Protection of trial subjects

The trial was conducted according to the principles of Good Clinical Practice and the Declaration of Helsinki and in agreement with the Austrian laws and regulation. The Ethics Committee of the Medical University of Vienna approved the trial. As BQ-123 was applied during cardiac surgery for the first time, the study was divided into a "pilot phase" and a "main trial" in order to improve safety. During the "pilot phase", which was intended to precede the "main trial", 30 subjects were randomized to receive either the placebo or half (3.75 µmol in the first and last cardioplegia, in total 7.5 µmol) of the in the "main trial" planned BQ-123 dose. Catecholamines given at the time of termination of surgery were the saftey endpoint. Further safety measures included the performance of liver function tests after BQ-123 administration, postoperative blood pressure measurements and the assessment of postoperative catecholamine requirements.

Background therapy

Evidence for comparator

Actual start date of recruitment

24 Oct 2012

Long term follow-up planned

Yes

Long term follow-up rationale

Scientific research, Efficacy

Long term follow-up duration

6 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Austria: 36

Worldwide total number of subjects

EEA total number of subjects

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

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Recruitment details

Patients who were scheduled for on-pump coronary artery bypass grafting at the Medical University of Vienna were assessed for eligibility. A sample size of a total of 120 subjects was calculated ("pilot trial": 30 subjects; "main trial": 90 subjects). The trial was discontinued after the "pilot phase".

Screening details

A total of 36 patients signed the informed consent to participate in the trial. Of them, 30 subjects were randomized.

Number of subjects started

Number of subjects completed

Reason: Number of subjects

Consent withdrawn by subject: 1

Reason: Number of subjects

Organizational reason: 1

Reason: Number of subjects

Physician decision: 1

Reason: Number of subjects

Exclusion criterion: 3

Period 1 title

Pilot phase (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer

Are arms mutually exclusive

Yes

BQ-123

Arm description

BQ-123 (7.5 µmol) dissolved in 0.9% NaCl was added to the blood cardioplegic solution used during cardiopulmonary bypass

Arm type

Experimental

Investigational medicinal product name

BQ-123 Sodium Salt

Investigational medicinal product code

Other name

Cyclo(D-trp-D-asp-L-pro-D-val-L-leu) sodium salt

Pharmaceutical forms

Powder for solution for injection/infusion

Routes of administration

Intracoronary use

Dosage and administration details

Subjects received a total of 7.5 µmol BQ-123 dissolved in 50ml 0,9% NaCL added to the blood cardioplegic solution used during cardiopulmonary bypass (3.75 µmol BQ-123 in the first cardioplegia and 3.75 µmol BQ-123 in the last cardioplegia).

Placebo

Arm description

0.9% NaCl was added to the blood cardioplegic solution used during cardiopulmonary bypass

Arm type

Placebo

Investigational medicinal product name

0,9% Sodium chloride solution

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intracoronary use

Dosage and administration details

Subjects received 0,9% NaCL added to the blood cardioplegic solution used during cardiopulmonary bypass.

Number of subjects in period 1 ^[1]	BQ-123	Placebo
Started	15	15
Completed	15	14
Not completed	0	1
Lost to follow-up	-	1

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: 36 subjects were enrolled in the trial. Of them, 6 patients were excluded from the trial prior to randomization and drug administration. Reasons for exclusion from the trial included the following: consent withdrawn by subject (1 patient), organizational reason (1 patient), physician decision (1 patient), and exclusion criterion (3 patients).

Baseline characteristics

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Reporting group title

BQ-123

Reporting group description

BQ-123 (7.5 µmol) dissolved in 0.9% NaCl was added to the blood cardioplegic solution used during cardiopulmonary bypass

Reporting group title

Placebo

Reporting group description

0.9% NaCl was added to the blood cardioplegic solution used during cardiopulmonary bypass

Reporting group values	BQ-123	Placebo	Total
Number of subjects	15	15	30
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	8	5	13
From 65-84 years	7	10	17
85 years and over	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	65.8 ± 10.6	67.4 ± 9.4	-
Gender categorical
Units: Subjects
Female	2	5	7
Male	13	10	23
New York Heart Association (NYHA) functional class
Units: Subjects
NYHA functional class I	3	3	6
NYHA functional class II	8	7	15
NYHA functional class III	4	5	9
NYHA functional class IV	0	0	0
Angina pectoris
Units: Subjects
No angina pectoris	4	2	6
Stable angina pectoris	8	9	17
Unstable angina pectoris	2	3	5
Atypical angina pectoris	1	1	2
Number of bypass grafts (intraoperative)
Units: Subjects
1 graft	0	1	1
2 grafts	3	2	5
3 grafts	10	8	18
4 grafts	2	4	6
Height
Units: cm
arithmetic mean (standard deviation)	174.7 ± 9.7	170.5 ± 10.8	-
Weight
Units: kg
arithmetic mean (standard deviation)	90.5 ± 9.7	80.1 ± 14.1	-
Body mass index
Units: kg/m2
arithmetic mean (standard deviation)	29.7 ± 3.1	27.5 ± 4.0	-
EuroScore II
Units: Percentage
arithmetic mean (standard deviation)	1.4 ± 0.8	1.8 ± 1.1	-
Left ventricular ejection fraction (cardiac magnetic resonance imaging)
Units: Percentage
arithmetic mean (standard deviation)	63.3 ± 12.1	59.7 ± 11.2	-
Aortic cross-clamp time
Units: Minutes
arithmetic mean (standard deviation)	76.9 ± 31.9	88.4 ± 35.2	-
Extracorporeal circulation time
Units: Minutes
arithmetic mean (standard deviation)	130.3 ± 39.5	146.8 ± 63.3	-

End points

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Reporting group title

BQ-123

Reporting group description

BQ-123 (7.5 µmol) dissolved in 0.9% NaCl was added to the blood cardioplegic solution used during cardiopulmonary bypass

Reporting group title

Placebo

Reporting group description

0.9% NaCl was added to the blood cardioplegic solution used during cardiopulmonary bypass

Primary: Area under the curve (AUC) of myocard specific creatinephosphokinase-MB isoform (CK-MB)

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End point title

Area under the curve (AUC) of myocard specific creatinephosphokinase-MB isoform (CK-MB)

End point description

Only patients with no missing value were included in the statistical analysis.

End point type

Primary

End point timeframe

CK-MB levels were measured was measured 4, 12, 24, 48 and 72 hours after the operation.

End point values	BQ-123	Placebo
Number of subjects analysed	7	5
Units: U/l*hours
arithmetic mean (standard deviation)	2562.9 ± 1120.4	2366.6 ± 1299.6

AUC of CK-MB

Comparison groups

BQ-123 v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.785

Method

t-test, 2-sided

Confidence interval

Adverse events

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Timeframe for reporting adverse events

Adverse events occuring within 6 months after the surgery are reported.

Adverse event reporting additional description

Non-serious adverse events were assessed by retrospective medical chart review. This retrospective medical chart review was conducted several years after the study was stopped.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

23.0

Reporting group title

BQ-123

Reporting group description

BQ-123 (7.5 µmol) dissolved in NaCl 0.9% was added to the blood cardioplegic solution used during cardiopulmonary bypass

Reporting group title

Placebo

Reporting group description

NaCl 0.9% was added to the blood cardioplegic solution used during cardiopulmonary bypass

Serious adverse events	BQ-123	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 15 (40.00%)	4 / 15 (26.67%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Investigations
Blood electrolytes abnormal
alternative assessment type: Systematic
subjects affected / exposed	1 / 15 (6.67%)	0 / 15 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Cardiac failure acute
alternative assessment type: Systematic
subjects affected / exposed	1 / 15 (6.67%)	1 / 15 (6.67%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary vascular graft occlusion
alternative assessment type: Systematic
subjects affected / exposed	1 / 15 (6.67%)	0 / 15 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Asystole
alternative assessment type: Systematic
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
alternative assessment type: Systematic
subjects affected / exposed	1 / 15 (6.67%)	0 / 15 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
alternative assessment type: Systematic
subjects affected / exposed	1 / 15 (6.67%)	0 / 15 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac procedure complication
alternative assessment type: Systematic
subjects affected / exposed	1 / 15 (6.67%)	0 / 15 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
General physical health deterioration
alternative assessment type: Systematic
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
alternative assessment type: Systematic
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Pancreatitis
alternative assessment type: Systematic
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
alternative assessment type: Systematic
subjects affected / exposed	1 / 15 (6.67%)	0 / 15 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Postoperative wound infection
alternative assessment type: Systematic
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	BQ-123	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	14 / 15 (93.33%)	15 / 15 (100.00%)
Vascular disorders
Thrombophlebitis
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Epistaxis
subjects affected / exposed	1 / 15 (6.67%)	3 / 15 (20.00%)
occurrences all number	1	3
Hemodynamic instability
subjects affected / exposed	1 / 15 (6.67%)	2 / 15 (13.33%)
occurrences all number	1	2
Lymphoedema
subjects affected / exposed	1 / 15 (6.67%)	0 / 15 (0.00%)
occurrences all number	1	0
Chronic venous insufficiency
subjects affected / exposed	1 / 15 (6.67%)	0 / 15 (0.00%)
occurrences all number	1	0
General disorders and administration site conditions
Weakness
subjects affected / exposed	4 / 15 (26.67%)	1 / 15 (6.67%)
occurrences all number	4	1
Sensation of heat
subjects affected / exposed	1 / 15 (6.67%)	0 / 15 (0.00%)
occurrences all number	1	0
Heavy sweating
subjects affected / exposed	1 / 15 (6.67%)	1 / 15 (6.67%)
occurrences all number	1	1
Tiredness
subjects affected / exposed	2 / 15 (13.33%)	0 / 15 (0.00%)
occurrences all number	2	0
Fever
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Respiratory, thoracic and mediastinal disorders
Hoarseness
subjects affected / exposed	1 / 15 (6.67%)	0 / 15 (0.00%)
occurrences all number	1	0
Pleural effusion
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Cold
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Pneumonia
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Psychiatric disorders
Panic attack
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Acute stress disorder
subjects affected / exposed	3 / 15 (20.00%)	1 / 15 (6.67%)
occurrences all number	3	1
Hallucination, visual
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Disorientation
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Investigations
Pancreatic enzymes increased
subjects affected / exposed	1 / 15 (6.67%)	1 / 15 (6.67%)
occurrences all number	1	1
Deranged liver function tests
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
C-reactive protein abnormal
subjects affected / exposed	3 / 15 (20.00%)	1 / 15 (6.67%)
occurrences all number	3	1
Blood culture positive
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Catheter culture positive
subjects affected / exposed	2 / 15 (13.33%)	2 / 15 (13.33%)
occurrences all number	2	2
Abnormal EEG
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Injury, poisoning and procedural complications
Radial nerve compression
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Anaemia postoperative
subjects affected / exposed	6 / 15 (40.00%)	6 / 15 (40.00%)
occurrences all number	6	6
Postoperative wound infection
subjects affected / exposed	1 / 15 (6.67%)	2 / 15 (13.33%)
occurrences all number	1	2
Incision site impaired healing
subjects affected / exposed	2 / 15 (13.33%)	1 / 15 (6.67%)
occurrences all number	2	1
Intraoperative hemorrhage
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Postpericardiotomy syndrome
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Fall
subjects affected / exposed	1 / 15 (6.67%)	0 / 15 (0.00%)
occurrences all number	1	0
Surgical emphysema
subjects affected / exposed	1 / 15 (6.67%)	0 / 15 (0.00%)
occurrences all number	1	0
Cardiac disorders
Pericardial effusion
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Atrial fibrillation
subjects affected / exposed	7 / 15 (46.67%)	4 / 15 (26.67%)
occurrences all number	7	4
Arrhythmia
subjects affected / exposed	1 / 15 (6.67%)	4 / 15 (26.67%)
occurrences all number	1	4
Dyspnea exacerbated
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Nervous system disorders
Lightheadedness
subjects affected / exposed	0 / 15 (0.00%)	2 / 15 (13.33%)
occurrences all number	0	2
Carpal tunnel syndrome
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Benign paroxysmal positional vertigo
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Dysaesthesia of upper extremity
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Eye disorders
Retinal vascular occlusion
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Gastrointestinal disorders
Ache stomach
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Haematochezia
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Proctitis
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Colonic polyp
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Skin and subcutaneous tissue disorders
Localized rash
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Decubitus
subjects affected / exposed	1 / 15 (6.67%)	0 / 15 (0.00%)
occurrences all number	1	0
Renal and urinary disorders
Urinary tract infection bacterial
subjects affected / exposed	1 / 15 (6.67%)	2 / 15 (13.33%)
occurrences all number	1	2
Impaired renal function
subjects affected / exposed	2 / 15 (13.33%)	0 / 15 (0.00%)
occurrences all number	2	0
Endocrine disorders
Hyperparathyroidism
subjects affected / exposed	1 / 15 (6.67%)	0 / 15 (0.00%)
occurrences all number	1	0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
subjects affected / exposed	0 / 15 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	1
Metabolism and nutrition disorders
Hyperkalaemia
subjects affected / exposed	2 / 15 (13.33%)	1 / 15 (6.67%)
occurrences all number	2	1

More information

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Were there any global substantial amendments to the protocol? Yes

11 Apr 2012

The primary endpoint of the study was changed from "coronary artery bypass graft blood flow assessed by Doppler flow probe measurement 15 minutes after protamine administration" to "area under the curve (AUC) of myocard specific creatinephosphokinase-MB isoform (CK-MB)". A new calculation of the required sample size was performed based on the primary endpoint AUC of CK-MB evaluated 2, 4, 12, 24, 48 and 72 hours after the operation. A sample size of 45 patients in each group was calculated. As this medication was applied during cardiac surgery for the first time, a pilot phase with 30 participants (15 treated with half dose BQ-123 and 15 placebo) was additionally implemented. The performance of a proteomic analysis of blood and plasma samples was added to the protocol. Exclusion criteria were changed to: • Significant liver disease (transaminases and/or gamma-GT > 3 fold upper limit) • Glomerular filtration rate < 40mL/h • History of severe congestive heart failure (left ventricular ejection fraction < 35%) • Current atrial fibrillation • Significant valvular heart disease requiring valve replacement • Primary myocardial disease • Acute coronary syndrome or cardiogenic shock (sRR < 90mmHg or need for inotropic support) • Women with child-bearing potential • Subjects with contraindications for CMR (cardiac magnetic resonance) • Inability to read, understand and sign the informed consent • Life expectancy <1y • Prior organ transplantation • Participation in a clinical trial using an investigational medical product

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
15 Oct 2015	The study was stopped after finishing the "pilot phase". The "main trial" was never started.	-

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

Preop. CK-MB levels were not measured. Postop. CK-MB levels couldn't be measured in all samples (17.8% of the data are missing). Non-serious adverse events were assessed by retrospective medical chart review several years after the study was stopped.

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Clinical trials

Clinical Trial Results:
Short-term endothelin A receptor blockade in patients with on-pump coronary artery bypass grafting

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Area under the curve (AUC) of myocard specific creatinephosphokinase-MB isoform (CK-MB)

Primary: Area under the curve (AUC) of myocard specific creatinephosphokinase-MB isoform (CK-MB)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical trials

Clinical Trial Results: Short-term endothelin A receptor blockade in patients with on-pump coronary artery bypass grafting

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Area under the curve (AUC) of myocard specific creatinephosphokinase-MB isoform (CK-MB)

Primary: Area under the curve (AUC) of myocard specific creatinephosphokinase-MB isoform (CK-MB)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Short-term endothelin A receptor blockade in patients with on-pump coronary artery bypass grafting