Aspirin Twice Daily in Diabetic Patients With Coronary Artery Disease

NCT01617031 | Completed

• 1 other identifier: LRB-10-023
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

aspirin; diabetes mellitus; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Closure time after exposure of total blood to Collagen-epinephrine

  10 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Lariboisière: lead

Study Sites (1)

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

Paris, 75010, France

Location

MeSH Terms

Conditions

Diabetes Mellitus; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Patrick Henry, MD-PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor in the Department of Cardiology, Principal Investigator

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: June 12, 2012
• Study Start: September 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2012
• Last Updated: June 12, 2012

Record last verified: 2012-06

Locations

FR (1)