Assessment of Thrombogenicity in Acute Coronary Syndrome

Completed

• Conditions: Type 2 Diabetes Mellitus; Acute Coronary Syndrome

• Registration Number: NCT00728286
• Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

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.

Study Timeline

• Study First Submitted: 2008-08-01
• Study First Submitted QC: 2008-08-01
• Study First Posted: 2008-08-05
• Study Start: 2008-10
• Primary Completion: 2011-01
• Study Completion: 2011-05
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thrombus area	Within 10 days after acute coronary syndrome

Secondary Outcome Measures

Name	Time	Method
Factors affecting thrombus area	Within ten days after acute coronary syndrome

Trial Locations

Locations (1)

Royal Victoria Hospital, Newcastle upon Tyne Hospitals NHS Trust; 🇬🇧 Newcastle upon Tyne, Tyne and Wear, United Kingdom