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

This study has been completed.
Sponsor:
Collaborators:
British Heart Foundation
University of Newcastle Upon-Tyne
Information provided by (Responsible Party):
Azfar G Zaman, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00728156
First received: August 1, 2008
Last updated: May 20, 2012
Last verified: May 2012
  Purpose

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 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 90
Study Start Date: August 2009
Study Completion Date: April 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728156

Locations
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
Investigators
Principal Investigator: Azfar G Zaman, MD FRCP Consultant cardiologist and Honoraray Lecturer
  More Information

Publications:
Responsible Party: Azfar G Zaman, Consultant Cardiologist and Reader, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00728156     History of Changes
Other Study ID Numbers: 3639a, British Heart Foundation
Study First Received: August 1, 2008
Last Updated: May 20, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Thrombosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Embolism and Thrombosis
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on April 17, 2014