Aspirin Twice Daily in Diabetic Patients With Coronary Artery Disease
Study Details
Study Description
Brief Summary
The aim of the study is to evaluate platelet function variations according to the delay since last aspirin intake (12 vs 24 hours)in a population of diabetic patients with previous Coronary Artery Disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
We have previously demonstrated that there was a time-dependant efficacy of aspirin on platelet function. In this study, we investigate platelet function (fundamental research) according to the delay since last aspirin intake (12 vs 24 hours)in a population of diabetic patients with previous Coronary Artery Disease routinely treated with aspirin. In order to eliminate any variation linked to a cumulative dose effect of aspirn, platelet function is assessed 24 hours after a single 150 mg aspirin intake or 12 hours after a 75 mg aspirin intake given twice per day (corresponding to the same total dose of 150 mg /day). Light transmission aggregometry triggered by arachidonic acid 0.5mg/mL (LTA-AA) is the main endpoint of the study (intensity and velocity of agregation following exposure to arachidonic acid 0.5 mg/ml).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Diabetic patients with coronary artery disease Type 2 diabetic patients with previous coronary artery disease. All patients are routinely treated with aspirin in secondary prevention of cardiovascular disease. Coronary artery disease is defined as a previous coronary angiography with at least 1 coronary artery stenosis >50%. Type 2 diabetes is defined as patients with diabetes discovered after 30 years old and insulin was not the first treatment except in case of acute coronary syndrome. |
Outcome Measures
Primary Outcome Measures
- Intensity of platelet agregation following exposure to 0.5 mg/ml arachidonic acid [10 days]
Flow cytometry study of the intensity of platelet agregation following exposure of Platelet reach plasma to 0.5 mg/ml arachidonic acid
Secondary Outcome Measures
- Closure time after exposure of total blood to Collagen-epinephrine [10 days]
Closure time after exposure of total blood to Collagen-epinephrine using Platelet Function Analyzer-100 (PFA-100) with collagen-epinephrine (EPI) cartridge.
Eligibility Criteria
Criteria
Inclusion Criteria:
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type 2 diabetes mellitus
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documented coronary artery disease
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treatment with aspirin for at least 7 days before randomization
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one of the following additional criteria defined from our previous study9: current smoking, hs-CRP > 4mg/L, fibrinogen > 4g/L and/or platelet count > 270 103/mm3
Exclusion Criteria:
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oral anticoagulants, heparin, thrombolytic agents, non-steroidal anti-inflammatory drugs, prasugrel
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family or personal history of bleeding or thrombophilic disorders
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platelet count > 600x103/mm3 or < 150x103/mm3
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hematocrit > 50% or < 25%
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creatinine clearance < 30mL/min
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low compliance before enrollment
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cancer considered not in remission or those having undergone major surgery within the month prior to enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Cardiology-Lariboisiere Hospital-Assistance Publique-Hôpitaux de Paris | Paris | France | 75010 |
Sponsors and Collaborators
- Hopital Lariboisière
Investigators
- Study Director: Patrick Henry, MD-PhD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LRB-10-023