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Clinical Trials/NCT00728286
NCT00728286
Completed
Not Applicable

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

Newcastle-upon-Tyne Hospitals NHS Trust1 site in 1 country90 target enrollmentOctober 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Enrollment
90
Locations
1
Primary Endpoint
Thrombus area
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
May 2011
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Thrombus area

Time Frame: Within 10 days after acute coronary syndrome

Secondary Outcomes

  • Factors affecting thrombus area(Within ten days after acute coronary syndrome)

Study Sites (1)

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