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Aspirin Twice Daily in Diabetic Patients With Coronary Artery Disease

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ClinicalTrials.gov Identifier: NCT01617031
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : June 12, 2012
Sponsor:
Information provided by (Responsible Party):
Dr Jean-Guillaume DILLINGER, Assistance Publique - Hôpitaux de Paris

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.

Condition or disease
Diabetes Mellitus

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
Actual Enrollment : 92 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biological Efficacy of Twice Daily Aspirin in Type 2 Diabetic Patients With Coronary Artery Disease
Study Start Date : September 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617031


Locations
France
Department of Cardiology-Lariboisiere Hospital-Assistance Publique-Hôpitaux de Paris
Paris, France, 75010
Sponsors and Collaborators
Hopital Lariboisière
Investigators
Study Director: Patrick Henry, MD-PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Dr Jean-Guillaume DILLINGER, Medical Doctor in the Department of Cardiology, Principal Investigator, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01617031     History of Changes
Other Study ID Numbers: LRB-10-023
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: June 12, 2012
Last Verified: June 2012

Keywords provided by Dr Jean-Guillaume DILLINGER, Assistance Publique - Hôpitaux de Paris:
aspirin
diabetes mellitus
coronary artery disease

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics