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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus; Coronary Artery Disease
• Interventions: Drug: placebo; Drug: clopidogrel

• Registration Number: NCT00728156
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2008-08-01
• Study First Submitted QC: 2008-08-04
• Study First Posted: 2008-08-05
• Study Start: 2009-08
• Primary Completion: 2010-12
• Study Completion: 2012-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P	placebo	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.
C	clopidogrel	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).

Primary Outcome Measures

Name	Time	Method
To compare the effect of Clopidogrel in reduction of thrombogenicity in patients with T2DM and CAD with placebo	seven days

Secondary Outcome Measures

Name	Time	Method
To identify patients (in particular T2DM patients with CAD) resistant to oral antiplatelet therapy	seven days
To characterise features in T2DM patients responsible for increased thrombogenicity	seven days

Trial Locations

Locations (2)

Newcastle Diabetes Centre, Newcastle General Hospital; 🇬🇧 Newcastle upon Tyne, Tyne and Wear, United Kingdom

Freeman Hospital; 🇬🇧 Newcastle upon Tyne, Tyne and Wear, United Kingdom