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

Phase 4TerminatedNCT01612884

Indiana University67 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Thrombosis Coronary Artery Disease

Interventions

PrasugrelDRUG

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

ClopidogrelDRUG

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Eskenazi Health

Indianapolis, Indiana, United States

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Thrombelastography (TEG) MA

Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel

Time frame: 1 day

Secondary Outcomes

Number of Participants With Ischemic Events

Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention

Time frame: 6 months

Number of Participants With Bleeding Events

Major or Minor Bleeding according to TIMI criteria

Time frame: 6 months

Data from ClinicalTrials.gov

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