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

Primary Purpose

Type 2 Diabetes Mellitus, Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
clopidogrel
placebo
Sponsored by
Newcastle-upon-Tyne Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes mellitus, Coronary artery disease, Platelet dependent thrombogenicity, Aspirin, Clopidogrel, Badimon Chamber

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Newcastle Diabetes Centre, Newcastle General Hospital
  • Freeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

C

P

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 1, 2008
Last Updated
October 7, 2015
Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators
British Heart Foundation, University of Newcastle Upon-Tyne
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1. Study Identification

Unique Protocol Identification Number
NCT00728156
Brief Title
Platelet-dependent Thrombosis: a Placebo-controlled Trial of Antiplatelet Therapy (Clopidogrel)
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 Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators
British Heart Foundation, University of Newcastle Upon-Tyne

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Coronary Artery Disease
Keywords
Type 2 Diabetes mellitus, Coronary artery disease, Platelet dependent thrombogenicity, Aspirin, Clopidogrel, Badimon Chamber

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
C
Arm Type
Active Comparator
Arm Description
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).
Arm Title
P
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Other Intervention Name(s)
Plavix, 75 milligrams, Sanofi Pharma Bristol-Myers Squibb SNC, 174 Avenue de France, F-75013 Paris - France, EU/1/98/069/005a
Intervention Description
75 milligrams, oral, clopidogrel, one tablet daily, for seven days after the baseline chamber study.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo: Hydroxy methyl cellulose, similar in weight to the active medication 75 mgs, oral tablets, once a day
Primary Outcome Measure Information:
Title
To compare the effect of Clopidogrel in reduction of thrombogenicity in patients with T2DM and CAD with placebo
Time Frame
seven days
Secondary Outcome Measure Information:
Title
To identify patients (in particular T2DM patients with CAD) resistant to oral antiplatelet therapy
Time Frame
seven days
Title
To characterise features in T2DM patients responsible for increased thrombogenicity
Time Frame
seven days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azfar G Zaman, MD FRCP
Organizational Affiliation
Consultant cardiologist and Honoraray Lecturer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Newcastle Diabetes Centre, Newcastle General Hospital
City
Newcastle upon Tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE77DN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18983525
Citation
Natarajan A, Marshall SM, Worthley SG, Badimon JJ, Zaman AG. The presence of coronary artery disease increases platelet-dependent thrombosis in patients with type 2 diabetes mellitus. J Thromb Haemost. 2008 Dec;6(12):2210-3. doi: 10.1111/j.1538-7836.2008.03176.x. Epub 2008 Oct 1. No abstract available.
Results Reference
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PubMed Identifier
11691500
Citation
Osende JI, Badimon JJ, Fuster V, Herson P, Rabito P, Vidhun R, Zaman A, Rodriguez OJ, Lev EI, Rauch U, Heflt G, Fallon JT, Crandall JP. Blood thrombogenicity in type 2 diabetes mellitus patients is associated with glycemic control. J Am Coll Cardiol. 2001 Nov 1;38(5):1307-12. doi: 10.1016/s0735-1097(01)01555-8.
Results Reference
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PubMed Identifier
10676673
Citation
Shechter M, Merz CN, Paul-Labrador MJ, Kaul S. Blood glucose and platelet-dependent thrombosis in patients with coronary artery disease. J Am Coll Cardiol. 2000 Feb;35(2):300-7. doi: 10.1016/s0735-1097(99)00545-8.
Results Reference
background
PubMed Identifier
11031221
Citation
Helft G, Osende JI, Worthley SG, Zaman AG, Rodriguez OJ, Lev EI, Farkouh ME, Fuster V, Badimon JJ, Chesebro JH. Acute antithrombotic effect of a front-loaded regimen of clopidogrel in patients with atherosclerosis on aspirin. Arterioscler Thromb Vasc Biol. 2000 Oct;20(10):2316-21. doi: 10.1161/01.atv.20.10.2316.
Results Reference
background
PubMed Identifier
18537103
Citation
Natarajan A, Zaman AG, Marshall SM. Platelet hyperactivity in type 2 diabetes: role of antiplatelet agents. Diab Vasc Dis Res. 2008 Jun;5(2):138-44. doi: 10.3132/dvdr.2008.023.
Results Reference
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Platelet-dependent Thrombosis: a Placebo-controlled Trial of Antiplatelet Therapy (Clopidogrel)

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