Assessment of Thrombogenicity in Acute Coronary Syndrome

Newcastle-upon-Tyne Hospitals NHS Trust

Status: Completed

Conditions: Acute Coronary Syndrome; Type 2 Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT00728286

3639b

British Heart Foundation (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 1 patient group

Type 2 diabetes mellitus

Description:

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.