Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)

Study Overview
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Brief Summary
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Personalized treatment approaches and antiplatelet drug choice have been proposed to optimize safety of coronary stenting by reducing heart attacks and repeat interventions while simultaneously minimizing adverse bleeding events. This study compares the efficacy of two laboratory guided treatment algorithms to personalize antiplatelet medication choice after coronary stenting

Official Title
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Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)

Conditions
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Thrombosis, Coronary Artery Disease

Intervention / Treatment
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* Drug: Prasugrel
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted with acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction) and referred for coronary angiography. Current therapy with clopidogrel (at least 300mg loading dose, or 75mg po daily for >5 days) Age range 21-75 years. Exclusion Criteria: Unable to give consent Age younger than 21 years, greater than 75 years History of stroke Body weight <60 kg Acute STEMI, Thrombocytopenia<100'000, requirement for chronic warfarin therapy

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TEG<br>Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69 | Drug: Prasugrel<br>* Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder<br>Drug: Clopidogrel<br>* Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder<br>|
| Other: Light transmittance aggregometry<br>Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9% | Drug: Prasugrel<br>* Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder<br>Drug: Clopidogrel<br>* Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombelastography (TEG) MA | Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Ischemic Events | Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention | 6 months | 
| Number of Participants With Bleeding Events | Major or Minor Bleeding according to TIMI criteria | 6 months |