Aspirin Response in High Risk Patients With Coronary Artery Disease
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|ClinicalTrials.gov Identifier: NCT01383304|
Recruitment Status : Unknown
Verified May 2015 by University of Aarhus.
Recruitment status was: Active, not recruiting
First Posted : June 28, 2011
Last Update Posted : May 12, 2016
Previous studies indicate that patients with cardiovascular disease have a variable response to aspirin. Despite treatment with aspirin a large number of patients suffer a myocardial infarction. This has given rise to the phenomenon "aspirin low-responsiveness". Laboratory aspirin low-responsiveness can be defined as the failure of aspirin to inhibit platelet production of thromboxane A2 or inhibit thromboxane-dependent platelet aggregation. Whether a low platelet response to aspirin results in an increased risk of future thrombotic events is of great clinical significance, but is still unknown.
The investigators hypothesize that patients with a reduced response to aspirin, determined by platelet aggregation using the apparatus Verify Now Aspirin and Multiplate, have a higher risk of thrombosis.
The purpose of this study is to investigate whether a higher incidence of cardiovascular events is found in patients with coronary artery disease (CAD) having a reduced biochemical response to aspirin compared with CAD patients having a normal biochemical response to aspirin. In addition to CAD, all patients have at least one of the following risc factors: previous myocardial infarction, type 2 diabetes mellitus and/or renal insufficiency.
|Condition or disease|
|Coronary Artery Disease Myocardial Infarction Diabetes Mellitus Renal Insufficiency, Chronic|
|Study Type :||Observational|
|Actual Enrollment :||906 participants|
|Official Title:||Is a Reduced Biochemical Response to Aspirin Associated With Increased Cardiovascular Morbidity and Mortality in High Risk Patients With Coronary Artery Disease?|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||January 2011|
|Estimated Study Completion Date :||January 2017|
- Combined primary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke [ Time Frame: Evaluation after 3 years ]
- Combined secondary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke [ Time Frame: Evaluation after 5 years ]
- Single endpoints:cardiovascular death; acute myocardial infarction; ischemic stroke; stent thrombosis; all-cause death [ Time Frame: Evaluation after 3 and 5 years ]
- Genotype according to pre-specified genetic single nucleotide polymorphisms (SNPs) [ Time Frame: Baseline ]At the day of blood sampling, plasma samples are retrieved for DNA extraction. DNA samples are used to evaluate if pre-specified genetic single nucleotide polymorphisms (SNPs) are associated with platelet aggregation levels.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383304
|Department of Clinical Biochemistry, Aarhus University Hospital, Skejby|
|Aarhus N, Denmark, 8200|
|Principal Investigator:||Anne-Mette Hvas, MD, Ph.D||Department of Clinical Biochemistry, Aarhus University Hospital, Skejby, Denmark|