Aspirin Twice Daily in Diabetic Patients With Coronary Artery Disease

Biological Efficacy of Twice Daily Aspirin in Type 2 Diabetic Patients With Coronary Artery Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01617031

Enrollment

Registered

2012-06-12

Start date

2010-09-30

Completion date

2012-05-31

Last updated

2012-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

aspirin, diabetes mellitus, coronary artery disease

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results