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Assessment of Thrombogenicity in Acute Coronary Syndrome

This study has been completed.
Sponsor:
Collaborators:
British Heart Foundation
University of Newcastle Upon-Tyne
Information provided by (Responsible Party):
Azfar G Zaman, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00728286
First received: August 1, 2008
Last updated: May 20, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition
Type 2 Diabetes Mellitus
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Platelet-dependent Thrombosis in Patients With Acute Coronary Syndromes Using an ex Vivo Arterial Injury Model

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Primary Outcome Measures:
  • Thrombus area [ Time Frame: Within 10 days after acute coronary syndrome ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Factors affecting thrombus area [ Time Frame: Within ten days after acute coronary syndrome ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: October 2008
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728286

Locations
United Kingdom
Royal Victoria Hospital, Newcastle upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
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
  More Information

Publications:

Responsible Party: Azfar G Zaman, Consultant Cardiologist and Reader, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00728286     History of Changes
Other Study ID Numbers: 3639b, British Heart Foundation
Study First Received: August 1, 2008
Last Updated: May 20, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Type 2 Diabetes Mellitus
Acute Coronary Syndrome
Platelet dependent thrombogenicity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Acute Coronary Syndrome
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013