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Sponsors and Collaborators: |
Newcastle-upon-Tyne Hospitals NHS Trust British Heart Foundation University of Newcastle Upon-Tyne |
Information provided by: | Newcastle-upon-Tyne Hospitals NHS Trust |
ClinicalTrials.gov Identifier: | NCT00728156 |
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.
Condition | Intervention | Phase |
Type 2 Diabetes Mellitus Coronary Artery Disease |
Drug: clopidogrel Drug: placebo |
Phase IV |
MedlinePlus related topics: | Coronary Artery Disease Diabetes |
ChemIDplus related topics: | Cellulose Cellulose sodium phosphate Phosphocellulose Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate Methylcellulose BaseLine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 90 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
C: Active Comparator
Patients assigned to clopidogrel in addition to their standard care.(all patients will be on aspirin)
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Drug: clopidogrel
75 milligrams, oral, clopidogrel, one tablet daily, for seven days after the baseline chamber study.
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P: Placebo Comparator
Patients assigned to placebo in addition to their standard care.(all patients will be on aspirin)
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Drug: placebo
Placebo: Hydroxy methyl cellulose, similar in weight to the active medication 75 mgs, oral tablets, once a day
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with T2DM and CAS as defined below:
Exclusion Criteria:
Contact: Girish N Viswanathan, MRCP | +441912824210 | girish.viswanathan@newcastle.ac.uk |
Contact: Azfar G Zaman, MD FRCP | +44 191 2336161 ext 37277 | Azfar.Zaman@nuth.nhs.uk |
United Kingdom, Tyne and Wear | |||||
Newcastle Diabetes Centre, Newcastle General Hospital | Not yet recruiting | ||||
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE4 6BE | |||||
Contact: Girish N Viswanathan, MRCP +44 191 2824210 girish.viswanathan@newcastle.ac.uk | |||||
Contact: Sally M Marshall, MD FRCP +44 191 2820114 s.m.marshall@ncl.ac.uk | |||||
Sub-Investigator: Girish N Viswanathan, MRCP | |||||
Principal Investigator: Sally M Marshall, MD FRCP | |||||
Freeman Hospital | Not yet recruiting | ||||
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE77DN | |||||
Contact: Girish N Viswanathan, MRCP +441912824210 girish.viswanathan@newcastle.ac.uk | |||||
Contact: Azfar G Zaman, MD MRCP +441912336161 ext 37277 azfar.zaman@nuth.nhs.uk | |||||
Sub-Investigator: Girish N Viswanathan, MRCP | |||||
Principal Investigator: Azfar G Zaman, MD FRCP |
Newcastle-upon-Tyne Hospitals NHS Trust |
British Heart Foundation |
University of Newcastle Upon-Tyne |
Principal Investigator: | Azfar G Zaman, MD FRCP | Consultant cardiologist and Honoraray Lecturer |
Responsible Party: | Regional Cardiothoracic Centre, Freeeman Hospital ( Dr Azfar G Zaman, Consultant Cardiologist and Honorary Senior Lecturer ) |
Study ID Numbers: | 3639a, British Heart Foundation, funder, BHF/FS/07/033 |
First Received: | August 1, 2008 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00728156 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: National Health Service; United Kingdom: Research Ethics Committee |
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