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Type 2 Diabetes MellitusPhase 4NCT00728156

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

A Phase 4 study testing clopidogrel in people with Type 2 Diabetes Mellitus and Coronary Artery Disease, run by Newcastle-upon-Tyne Hospitals NHS Trust at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
clopidogrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
2 sitesUnited Kingdom
Study dates
Aug 2009to Apr 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Newcastle Diabetes Centre, Newcastle General Hospital

    Newcastle upon Tyne, Tyne and Wear, NE4 6BE

  • Freeman Hospital

    Newcastle upon Tyne, Tyne and Wear, NE77DN

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
clopidogrel, placebo
Keywords
Type 2 Diabetes mellitus, Coronary artery disease, Platelet dependent thrombogenicity, Aspirin, Clopidogrel, Badimon Chamber
Medical subject headings
Diabetes Mellitus, Type 2, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clopidogrelDrug

    Also called Plavix, 75 milligrams, Sanofi Pharma Bristol-Myers Squibb SNC, 174 Avenue de France, F-75013 Paris - France

    75 milligrams, oral, clopidogrel, one tablet daily, for seven days after the baseline chamber study.

  • placeboDrug

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

Study groups in NCT00728156
Study groupRoleWhat they receive
CActive comparatorPatients 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).
Receives: Drug: clopidogrel
PPlacebo comparatorPatients 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.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: seven days

Secondary outcomes (2)

  1. To identify patients (in particular T2DM patients with CAD) resistant to oral antiplatelet therapy

    Measured: seven days

  2. To characterise features in T2DM patients responsible for increased thrombogenicity

    Measured: seven days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2008 (estimated)
  2. Study startAug 2009
  3. Primary completionDec 2010
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00728156
Sponsor's protocol ID
3639a
Other IDs
British Heart Foundation
Status last verified
Oct 2015
First submitted
1 Aug 2008
Last updated
12 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18983525

  • 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.

    PubMed 11691500

  • 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.

    PubMed 10676673

  • 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.

    PubMed 11031221

  • 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.

    PubMed 18537103

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing clopidogrel in people with Type 2 Diabetes Mellitus and Coronary Artery Disease, run by Newcastle-upon-Tyne Hospitals NHS Trust at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare the effect of Clopidogrel in reduction of thrombogenicity in patients with T2DM and CAD with placebo (time frame: seven days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00728156, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.

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