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Completed

NCT Number: NCT01617031

Aspirin Twice Daily in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology-Lariboisiere Hospital-Assistance Publique-Hôpitaux de Paris

Paris, 75010, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hopital Lariboisière

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 12, 2012
Registry last updated
Jun 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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