Assessment of Thrombogenicity in Acute Coronary Syndrome

NCT ID: NCT00728286

Last Updated: 2015-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study is to assess platelet dependent thrombogenicity in patients after acute coronary syndrome using an ex vivo arterial injury model.

Detailed Description

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Abnormal platelet activity seen in patients with Type2 Diabetes Mellitus (T2DM) may be an important contributor to their enhanced cardiovascular risk and higher rates of cardiovascular events following acute coronary syndrome, despite dual antiplatelet therapy with aspirin and clopidogrel. We have earlier demonstrated high thrombogenicity in individuals with T2DM and CAD in the absence of acute ischaemic events, despite therapeutic doses of aspirin.We hypothesise that patients with T2DM will have increased thrombogenicity after acute coronary syndrome despite optimal secondary prevention medication.Measuring ex vivo thrombus area using an arterial injury model simulates plaque rupture and reflects the summative effect of all haemostatic abnormalities. The thrombus area of patients with ACS and T2DM will be compared to the controls without T2DM.

Conditions

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Type 2 Diabetes Mellitus Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Type 2 diabetes mellitus

We aim to determine the effects of dual antiplatelet therapy with aspirin 75mg once a day and clopidogrel 75mg once a day on platelet dependent thrombogenicity in patients with type 2 diabetes mellitus and acute coronary syndrome. Eighty patients (40 with type 2 diabetes and 40 without) have been studied one week after Non ST-elevation acute coronary syndrome. All patients were on secondary prevention therapy as recommended by international guidelines.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Acute coronary syndrome (WHO criteria) with raised cardiac troponin T
* Aged 18-80 years
* Stable Acute coronary syndrome
* On aspirin and clopidogrel
* Willing to participate in the study

Exclusion Criteria

* Smoking (current smokers or smokers who quit in the last 6 months preceding recruitment)
* Malignancy (any suspected or proven)
* Haematological disorders (bleeding disorders)
* Pre-menopausal women
* Use of corticosteroids/other antithrombotic agents (warfarin)
* Chronic liver disease
* Unable to consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Heart Foundation

OTHER

Sponsor Role collaborator

University of Newcastle Upon-Tyne

OTHER

Sponsor Role collaborator

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Azfar G Zaman, MD FRCP

Role: PRINCIPAL_INVESTIGATOR

Freeman Hospital, Newcastle upon Tyne NHS Trust, Newcastle upon Tyne. NE7 7DN

Locations

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Royal Victoria Hospital, Newcastle upon Tyne Hospitals NHS Trust

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 18983525 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11691500 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10676673 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11031221 (View on PubMed)

Other Identifiers

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British Heart Foundation

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

3639b

Identifier Type: -

Identifier Source: org_study_id

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