Clinical trial NCT01617031: Aspirin Twice Daily in Diabetic Patients With Coronary Artery Disease
Official title: Biological Efficacy of Twice Daily Aspirin in Type 2 Diabetic Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: aspirin
diabetes mellitus
coronary artery disease
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive stable DM patients presenting to the Department of Cardiology, Lariboisiere Hospital. Patients are eligible if they have DM and documented CAD and are treated for at least 7 days with a non-enteric-coated aspirin.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Intensity of platelet agregation following exposure to 0.5 mg/ml arachidonic acid
timeFrame: 10 days
Secondary outcomes:
measure: Closure time after exposure of total blood to Collagen-epinephrine
timeFrame: 10 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Department of Cardiology-Lariboisiere Hospital-Assistance Publique-Hôpitaux de Paris
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Patrick Henry, MD-PhD
role: STUDY_DIRECTOR
References: