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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01612884
• Other study ID #: 1106005745
• Status: Terminated
• Phase: Phase 4
• First received: June 4, 2012
• Last updated: March 28, 2018
• Start date: August 2011
• Est. completion date: March 2017

Study information

• Verified date: March 2018
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Thrombosis

Intervention

Drug:
• Prasugrel
Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
• Clopidogrel
Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder

Locations

Country	Name	City	State
United States	Eskenazi Health	Indianapolis	Indiana
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Ischemic Events	Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention	6 months
Secondary	Number of Participants With Bleeding Events	Major or Minor Bleeding according to TIMI criteria	6 months