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Completed

NCT Number: NCT00728156

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Freeman Hospital, Newcastle upon Tyne, Tyne and Wear, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

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

Drug

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

Primary outcomes

  1. To compare the effect of Clopidogrel in reduction of thrombogenicity in patients with T2DM and CAD with placebo

    Time frame: seven days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Other

Collaborators

  • British Heart Foundation
  • University of Newcastle Upon-Tyne

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Aug 5, 2008
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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