Aspirin Twice Daily in Diabetic Patients With Coronary Artery Disease

Hopital Lariboisière

Status: Completed

Conditions: Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT01617031

LRB-10-023

Details and patient eligibility

About

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.

Full 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).

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

92 participants in 1 patient group

Diabetic patients with coronary artery disease

Description:

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.