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

Phase 4

Terminated

• Conditions: Thrombosis; Coronary Artery Disease
• Interventions: Drug: Prasugrel; Drug: Clopidogrel

• Registration Number: NCT01612884
• Lead Sponsor: Indiana University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-06
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Results First Submitted: 2017-12-29
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-28
• Last Update Submitted: 2018-03-28
• Results First Posted: 2018-04-26
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEG	Prasugrel	Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA\<69
Light transmittance aggregometry	Prasugrel	Clopidogrel non-response defined as MPA ADP \>42.9% Clopidogrel response defined as MPA ADP \<42.9%
TEG	Clopidogrel	Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA\<69
Light transmittance aggregometry	Clopidogrel	Clopidogrel non-response defined as MPA ADP \>42.9% Clopidogrel response defined as MPA ADP \<42.9%

Primary Outcome Measures

Name	Time	Method
Thrombelastography (TEG) MA	1 day	Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Ischemic Events	6 months	Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention
Number of Participants With Bleeding Events	6 months	Major or Minor Bleeding according to TIMI criteria

Trial Locations

Locations (2)

Eskenazi Health; 🇺🇸 Indianapolis, Indiana, United States

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States