Aspirin Twice Daily in Diabetic Patients With Coronary Artery Disease
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Biological Efficacy of Twice Daily Aspirin in Type 2 Diabetic Patients With Coronary Artery Disease|
- Intensity of platelet agregation following exposure to 0.5 mg/ml arachidonic acid [ Time Frame: 10 days ] [ Designated as safety issue: No ]Flow cytometry study of the intensity of platelet agregation following exposure of Platelet reach plasma to 0.5 mg/ml arachidonic acid
- Closure time after exposure of total blood to Collagen-epinephrine [ Time Frame: 10 days ] [ Designated as safety issue: No ]Closure time after exposure of total blood to Collagen-epinephrine using Platelet Function Analyzer-100 (PFA-100) with collagen-epinephrine (EPI) cartridge.
|Study Start Date:||September 2010|
|Study Completion Date:||May 2012|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617031
|Department of Cardiology-Lariboisiere Hospital-Assistance Publique-Hôpitaux de Paris|
|Paris, France, 75010|
|Study Director:||Patrick Henry, MD-PhD||Assistance Publique - Hôpitaux de Paris|