Aspirin Twice Daily in Diabetic Patients With Coronary Artery Disease

June 11, 2012 updated by: Dr Jean-Guillaume DILLINGER, Hopital Lariboisière

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Department of Cardiology-Lariboisiere Hospital-Assistance Publique-Hôpitaux de Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Diabetic patients with coronary artery disease
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of platelet agregation following exposure to 0.5 mg/ml arachidonic acid
Time Frame: 10 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Closure time after exposure of total blood to Collagen-epinephrine
Time Frame: 10 days
Closure time after exposure of total blood to Collagen-epinephrine using Platelet Function Analyzer-100 (PFA-100) with collagen-epinephrine (EPI) cartridge.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Lariboisière

Investigators

  • Study Director: Patrick Henry, MD-PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

May 25, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (Estimate)

June 12, 2012

Study Record Updates

Last Update Posted (Estimate)

June 12, 2012

Last Update Submitted That Met QC Criteria

June 11, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRB-10-023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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