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

March 28, 2018 updated by: Rolf Kreutz, Indiana University
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Methodist Hospital
      • Indianapolis, Indiana, United States, 46202
        • Eskenazi Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: TEG
Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69
Drug: Prasugrel
Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
Drug: Clopidogrel
Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
Other: Light transmittance aggregometry
Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%
Drug: Prasugrel
Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
Drug: Clopidogrel
Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombelastography (TEG) MA
Time Frame: 1 day
Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Ischemic Events
Time Frame: 6 months
Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention
6 months
Number of Participants With Bleeding Events
Time Frame: 6 months
Major or Minor Bleeding according to TIMI criteria
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (Estimate)

June 6, 2012

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1106005745

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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