Assessment of Thrombogenicity in Acute Coronary Syndrome

October 7, 2015 updated by: Newcastle-upon-Tyne Hospitals NHS Trust

Assessment of Platelet-dependent Thrombosis in Patients With Acute Coronary Syndromes Using an ex Vivo Arterial Injury Model

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
        • Royal Victoria Hospital, Newcastle upon Tyne Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with non-ST elevation myocardial infarction - Acute Coronary syndrome (ACS) and on existing medication will undergo chamber study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Thrombus area
Time Frame: Within 10 days after acute coronary syndrome
Within 10 days after acute coronary syndrome

Secondary Outcome Measures

Outcome Measure
Time Frame
Factors affecting thrombus area
Time Frame: Within ten days after acute coronary syndrome
Within ten days after acute coronary syndrome

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Collaborators

British Heart Foundation
University of Newcastle Upon-Tyne

Investigators

  • Principal Investigator: Azfar G Zaman, MD FRCP, Freeman Hospital, Newcastle upon Tyne NHS Trust, Newcastle upon Tyne. NE7 7DN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

August 1, 2008

First Submitted That Met QC Criteria

August 1, 2008

First Posted (Estimate)

August 5, 2008

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3639b
  • British Heart Foundation (Other Grant/Funding Number: FS/033/07)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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