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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01617031 |
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Date of registration:
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25/05/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Aspirin Twice Daily in Diabetic Patients With Coronary Artery Disease
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Scientific title:
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Biological Efficacy of Twice Daily Aspirin in Type 2 Diabetic Patients With Coronary Artery Disease |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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92 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01617031 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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Patrick Henry, MD-PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus
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Primary Outcome(s)
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Intensity of platelet agregation following exposure to 0.5 mg/ml arachidonic acid
[Time Frame: 10 days]
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Secondary Outcome(s)
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Closure time after exposure of total blood to Collagen-epinephrine
[Time Frame: 10 days]
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Secondary ID(s)
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LRB-10-023
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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