Clinical Trial Results:
Antiplatelet and vascular effects of aspirin in healthy persons and patients with type 2 diabetes.
Summary
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EudraCT number |
2016-000515-32 |
Trial protocol |
DK |
Global end of trial date |
02 Dec 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Feb 2018
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First version publication date |
09 Feb 2018
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
2016-623
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Per Løgstrup Poulsen
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Sponsor organisation address |
Nørrebrogade 44, Aarhus, Denmark, 8000
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Public contact |
Coordinator, Liv Vernstrøm Hald, lvh@clin.au.dk
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Scientific contact |
Coordinator, Liv Vernstrøm Hald, lvh@clin.au.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Jan 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Dec 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Dec 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The aim is to investigate the effect of aspirin on platelet aggregation, endothelial-dependent vasodilation and arterial stiffness during 24 hours in patients with type 2 diabetes without known cardiovascular disease and in healthy controls.
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Protection of trial subjects |
Considering the small doses and short-term treatment, we found the risk minimal and acceptable. No specific measures were put in place.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 May 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 43
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Worldwide total number of subjects |
43
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EEA total number of subjects |
43
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
26
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From 65 to 84 years |
17
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85 years and over |
0
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Recruitment
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Recruitment details |
Controls were recruited from an excisting study population and patients were recruited from the outpatient clinic at the department of endocrinology, Aarhus University Hospital. | |||||||||||||||
Pre-assignment
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Screening details |
Patients were screened according to in- and exclusion criteria. There were no screening-log. | |||||||||||||||
Period 1
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Period 1 title |
Intervention (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Type 2 Diabetes | |||||||||||||||
Arm description |
Patients with type 2 diabetes | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Aspirin
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Investigational medicinal product code |
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Other name |
Acetylsalicylic-acid
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
75 mg, once daily
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Arm title
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Control group | |||||||||||||||
Arm description |
Non-diabetic controls | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Aspirin
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Investigational medicinal product code |
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Other name |
Acetylsalicylic-acid
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
75 mg, once daily
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Baseline characteristics reporting groups
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Reporting group title |
Type 2 Diabetes
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Reporting group description |
Patients with type 2 diabetes | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control group
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Reporting group description |
Non-diabetic controls | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Type 2 Diabetes
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Reporting group description |
Patients with type 2 diabetes | ||
Reporting group title |
Control group
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Reporting group description |
Non-diabetic controls |
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End point title |
24-hour antiplatelet effect of aspirin | ||||||||||||
End point description |
Difference between aggregation level 1 hour and 24 hours after aspirin ingestion.
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End point type |
Primary
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End point timeframe |
24 hours
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Statistical analysis title |
Mixed model analysis | ||||||||||||
Comparison groups |
Type 2 Diabetes v Control group
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Number of subjects included in analysis |
42
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Analysis specification |
Post-hoc
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Analysis type |
other | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
First patients first visit to last patients last visit
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Assessment type |
Systematic | |||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
Type 2 Diabetes
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Reporting group description |
Patients with type 2 diabetes | |||||||||||||||
Reporting group title |
Control group
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Reporting group description |
Non-diabetic controls | |||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: There were no adverse events |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/29175435 |