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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2017-03-31

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

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Detailed Description

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Conditions

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Thrombosis Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TEG

Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA\<69

Group Type OTHER

Prasugrel

Intervention Type DRUG

Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder

Clopidogrel

Intervention Type DRUG

Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder

Light transmittance aggregometry

Clopidogrel non-response defined as MPA ADP \>42.9% Clopidogrel response defined as MPA ADP \<42.9%

Group Type OTHER

Prasugrel

Intervention Type DRUG

Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder

Clopidogrel

Intervention Type DRUG

Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder

Interventions

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Prasugrel

Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder

Intervention Type DRUG

Clopidogrel

Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder

Intervention Type DRUG

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No