Status:
COMPLETED
Platelet-dependent Thrombosis: a Placebo-controlled Trial of Antiplatelet Therapy (Clopidogrel)
Lead Sponsor:
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborating Sponsors:
British Heart Foundation
University of Newcastle Upon-Tyne
Conditions:
Type 2 Diabetes Mellitus
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Patients with diabetes are more likely to develop furring of their coronary arteries and present with angina and heart attacks. Furthermore, after such an event, they have poorer outcomes (higher rate...
Detailed Description
The objective of this study is to compare the effect of Clopidogrel on platelet dependent thrombosis in patients with T2DM and CAD with placebo. The Badimon chamber, an ex vivo arterial injury model i...
Eligibility Criteria
Inclusion
- Patients with T2DM and CAS as defined below:
- Clinical definitions
- T2DM: Diagnosed according to the WHO criteria \[53\].
- CAD:Presence of any one of the following: Angina plus positive exercise tolerance test, enzyme and/or Q wave positive myocardial infarction, angiographic evidence ( \>50% stenosis of one vessel), percutaneous or surgical coronary revascularisation.
- Aged between 18 and 75
- Provided written consent for participation in the trial prior to any study-specific procedures or requirements.
Exclusion
- Contraindication to Clopidogrel
- Smoking (current smokers and patients who quit smoking less than six months)
- Malignancy(diagnosed or under investigation)
- Haematological disorders (Anaemia, malignancy, bleeding disorders)
- Women of child-bearing potential
- Use of corticosteroids/other antithrombotic agents(warfarin)
- Chronic liver disease (Cirrhosis, malignancy and patients with more than twice the upper limit of liver function tests)
- Unable to consent.
- Use of other investigational study drugs within 1 year prior to study entry
- Previous participation in this study
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00728156
Start Date
August 1 2009
End Date
April 1 2012
Last Update
October 12 2015
Active Locations (2)
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1
Newcastle Diabetes Centre, Newcastle General Hospital
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE4 6BE
2
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE77DN