Platelet-dependent Thrombosis: a Placebo-controlled Trial of Antiplatelet Therapy (Clopidogrel)
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|ClinicalTrials.gov Identifier: NCT00728156|
Recruitment Status : Completed
First Posted : August 5, 2008
Last Update Posted : October 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Coronary Artery Disease||Drug: clopidogrel Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Assessment of Platelet-dependent Thrombosis by an ex Vivo Arterial Injury Model: a Placebo Controlled Trial of Clopidogrel as Antiplatelet Therapy in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||April 2012|
Active Comparator: C
Patients assigned to clopidogrel in addition to their standard care.(all patients will be on aspirin)We aim to study the effect of clopidogrel as dual antiplatelet therapy in patients with established coronary artery disease and type 2 diabetes. Ninety patients with type 2 diabetes and stable coronary artery disease has been randomly treated with clopidogrel or placebo (45 each) for one week in addition to their standard care (including aspirin,75 mg once daily).
75 milligrams, oral, clopidogrel, one tablet daily, for seven days after the baseline chamber study.
Placebo Comparator: P
Patients assigned to placebo in addition to their standard care.(all patients will be on aspirin).This is a single-centre randomised double-blind placebo-controlled parallel design study, comparing efficacy of clopidogrel versus placebo in patients with T2DM and coronary artery disease. Ninety patients have completed the study. All patients were on their routine medications as per standard practice. After informed consent, participants were randomised to receive either clopidogrel 75mg daily or placebo for 7 days.
Placebo: Hydroxy methyl cellulose, similar in weight to the active medication 75 mgs, oral tablets, once a day
- To compare the effect of Clopidogrel in reduction of thrombogenicity in patients with T2DM and CAD with placebo [ Time Frame: seven days ]
- To identify patients (in particular T2DM patients with CAD) resistant to oral antiplatelet therapy [ Time Frame: seven days ]
- To characterise features in T2DM patients responsible for increased thrombogenicity [ Time Frame: seven days ]
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): NCT00728156
|Newcastle Diabetes Centre, Newcastle General Hospital|
|Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE4 6BE|
|Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE77DN|
|Principal Investigator:||Azfar G Zaman, MD FRCP||Consultant cardiologist and Honoraray Lecturer|