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

Indiana University

Status and phase: Terminated; Phase 4

Conditions: Coronary Artery Disease; Thrombosis

Treatments: Drug: Clopidogrel; Drug: Prasugrel

Study type: Interventional

Funder types: Other

Identifiers

NCT01612884

1106005745

Details and patient eligibility

About

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

Enrollment: 67 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

TEG

Other group

Description:

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

Treatment:

Drug: Prasugrel

Drug: Clopidogrel

Light transmittance aggregometry

Other group

Description:

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

Treatment:

Drug: Prasugrel

Drug: Clopidogrel