Aspirin Twice Daily in Diabetic Patients With Coronary Artery Disease

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617031
• Other study ID #: LRB-10-023
• Status: Completed
• Phase: Phase 4
• First received: May 25, 2012
• Last updated: June 11, 2012
• Start date: September 2010
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Hopital Lariboisière
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: May 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia

Locations

Country	Name	City	State
France	Department of Cardiology-Lariboisiere Hospital-Assistance Publique-Hôpitaux de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Lariboisière

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of platelet agregation following exposure to 0.5 mg/ml arachidonic acid	Flow cytometry study of the intensity of platelet agregation following exposure of Platelet reach plasma to 0.5 mg/ml arachidonic acid	10 days
Secondary	Closure time after exposure of total blood to Collagen-epinephrine	Closure time after exposure of total blood to Collagen-epinephrine using Platelet Function Analyzer-100 (PFA-100) with collagen-epinephrine (EPI) cartridge.	10 days