Aspirin Response in High Risk Patients With Coronary Artery Disease
|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
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|