Platelet-dependent Thrombosis: a Placebo-controlled Trial of Antiplatelet Therapy (Clopidogrel)
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 rates of death) and survivors are more likely to have recurring symptoms. Using a novel "clotting chamber" the investigators have shown that patients with diabetes are more likely to develop blood clots. This study will look at the role of different blood thinning medications in patients with diabetes. If successful, the investigators will provide evidence to conduct large clinical studies to look at the role of additional blood thinning medication in reducing heart attacks and strokes in patients with diabetes.
Type 2 Diabetes Mellitus
Coronary Artery Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- To compare the effect of Clopidogrel in reduction of thrombogenicity in patients with T2DM and CAD with placebo [ Time Frame: seven days ] [ Designated as safety issue: No ]
- To identify patients (in particular T2DM patients with CAD) resistant to oral antiplatelet therapy [ Time Frame: seven days ] [ Designated as safety issue: No ]
- To characterise features in T2DM patients responsible for increased thrombogenicity [ Time Frame: seven days ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Study Completion Date:||April 2012|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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
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 is used for this purpose. This model simulates the in vivo situation of high shear arterial wall damage and helps to quantify thrombus which is the sum endpoint of all haemostatic abnormalities seen in vitro.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728156
|Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE77DN|
|Newcastle Diabetes Centre, Newcastle General Hospital|
|Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE4 6BE|
|Principal Investigator:||Azfar G Zaman, MD FRCP||Consultant cardiologist and Honoraray Lecturer|