Assessment of Thrombogenicity in Acute Coronary Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes Mellitus, Acute Coronary Syndrome

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 diabetes mellitus<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombus area |  | Within 10 days after acute coronary syndrome | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors affecting thrombus area |  | Within ten days after acute coronary syndrome | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Acute Coronary Syndrome, Platelet dependent thrombogenicity