Aspirin Twice Daily in Diabetic Patients With Coronary Artery Disease

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT01617031
• Lead Sponsor: Hopital Lariboisière

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.

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 Timeline

• Study Start: 2010-09
• Primary Completion: 2011-03
• Study Completion: 2012-05
• Study First Submitted: 2012-05-25
• Status Verified: 2012-06
• Study First Submitted QC: 2012-06-11
• Last Update Submitted: 2012-06-11
• Study First Posted: 2012-06-12
• Last Update Posted: 2012-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• type 2 diabetes mellitus
• documented coronary artery disease
• treatment with aspirin for at least 7 days before randomization
• 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

• oral anticoagulants, heparin, thrombolytic agents, non-steroidal anti-inflammatory drugs, prasugrel
• family or personal history of bleeding or thrombophilic disorders
• platelet count > 600x103/mm3 or < 150x103/mm3
• hematocrit > 50% or < 25%
• creatinine clearance < 30mL/min
• low compliance before enrollment
• cancer considered not in remission or those having undergone major surgery within the month prior to enrollment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Cardiology-Lariboisiere Hospital-Assistance Publique-Hôpitaux de Paris; 🇫🇷 Paris, France