Aspirin Response in High Risk Patients With Coronary Artery Disease

• Conditions: Coronary Artery Disease; Myocardial Infarction; Diabetes Mellitus; Renal Insufficiency, Chronic

• Registration Number: NCT01383304
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2011-01
• Study First Submitted: 2011-06-22
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Status Verified: 2015-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 906

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined primary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke	Evaluation after 3 years

Secondary Outcome Measures

Name	Time	Method
Combined secondary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke	Evaluation after 5 years
Single endpoints:cardiovascular death; acute myocardial infarction; ischemic stroke; stent thrombosis; all-cause death	Evaluation after 3 and 5 years

Trial Locations

Locations (1)

Department of Clinical Biochemistry, Aarhus University Hospital, Skejby; 🇩🇰 Aarhus N, Denmark