This trial is active, not recruiting.

Conditions coronary artery disease, myocardial infarction, diabetes mellitus, renal insufficiency, chronic
Sponsor University of Aarhus
Collaborator Aarhus University Hospital Skejby
Start date November 2007
End date January 2011
Trial size 906 participants
Trial identifier NCT01383304, 22527


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Combined primary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke
time frame: Evaluation after 3 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Coronary artery disease verified by coronary angiogram - Treatment with aspirin 75 mg/d for at least the previous 7 days - Previous myocardial infarction more than one year ago (groups with previous myocardial infarction) - Type 2 diabetes mellitus treated with oral antidiabetics and/or insulin (groups with type 2 diabetes mellitus) - Renal insufficiency; glomerular filtration rate <60 ml/min at the time of blood sampling (groups with renal insufficiency) Exclusion Criteria: - Treatment with NSAIDs, clopidogrel, ticlopidine, dipyridamole, warfarin or any other drugs known to affect platelet function - Ischemic vascular event within the previous 12 months - Revascularization (angioplasty or coronary by-pass graft surgery) within the previous 12 months - Platelet count <120 x 10^9/L or >450 x 10^9/L - For patients without diabetes: fast glucose >7 mmol/L - Unable to give informed consent

Additional Information

Official title Is a Reduced Biochemical Response to Aspirin Associated With Increased Cardiovascular Morbidity and Mortality in High Risk Patients With Coronary Artery Disease?
Principal investigator Anne-Mette Hvas, MD, Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Aarhus.