Platelet-dependent Thrombosis: a Placebo-controlled Trial of Antiplatelet Therapy (Clopidogrel)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00728156
Recruitment Status : Completed
First Posted : August 5, 2008
Last Update Posted : October 12, 2015
British Heart Foundation
University of Newcastle Upon-Tyne
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

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 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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Coronary Artery Disease Drug: clopidogrel Drug: placebo Phase 4

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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).
Drug: clopidogrel
75 milligrams, oral, clopidogrel, one tablet daily, for seven days after the baseline chamber study.
Other Names:
  • Plavix, 75 milligrams
  • Sanofi Pharma Bristol-Myers Squibb SNC
  • 174 Avenue de France
  • F-75013 Paris - France
  • EU/1/98/069/005a

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.
Drug: placebo
Placebo: Hydroxy methyl cellulose, similar in weight to the active medication 75 mgs, oral tablets, once a day

Primary Outcome Measures :
  1. To compare the effect of Clopidogrel in reduction of thrombogenicity in patients with T2DM and CAD with placebo [ Time Frame: seven days ]

Secondary Outcome Measures :
  1. To identify patients (in particular T2DM patients with CAD) resistant to oral antiplatelet therapy [ Time Frame: seven days ]
  2. To characterise features in T2DM patients responsible for increased thrombogenicity [ Time Frame: seven days ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00728156

United Kingdom
Newcastle Diabetes Centre, Newcastle General Hospital
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE4 6BE
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE77DN
Sponsors and Collaborators
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: Newcastle-upon-Tyne Hospitals NHS Trust Identifier: NCT00728156     History of Changes
Other Study ID Numbers: 3639a
British Heart Foundation ( Other Grant/Funding Number: FS/033/07 )
First Posted: August 5, 2008    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Type 2 Diabetes mellitus
Coronary artery disease
Platelet dependent thrombogenicity
Badimon Chamber

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Embolism and Thrombosis
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors