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Aspirin Twice Daily in Diabetic Patients With Coronary Artery Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Jean-Guillaume DILLINGER, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01617031
First received: May 25, 2012
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Phase
Diabetes Mellitus
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biological Efficacy of Twice Daily Aspirin in Type 2 Diabetic Patients With Coronary Artery Disease

Resource links provided by NLM:

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

Further study details as provided by Hopital Lariboisière:

Primary Outcome Measures:
  • Intensity of platelet agregation following exposure to 0.5 mg/ml arachidonic acid [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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:
  • Closure time after exposure of total blood to Collagen-epinephrine [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Closure time after exposure of total blood to Collagen-epinephrine using Platelet Function Analyzer-100 (PFA-100) with collagen-epinephrine (EPI) cartridge.


Enrollment: 92
Study Start Date: September 2010
Study Completion Date: May 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 25, 2012
Last Updated: June 11, 2012
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Hopital Lariboisière:
aspirin
diabetes mellitus
coronary artery disease

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

ClinicalTrials.gov processed this record on May 21, 2013