Back to resultsAntiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)
Primary Purpose
Thrombosis, Coronary Artery Disease
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prasugrel
Clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Thrombosis
Eligibility Criteria
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
Sites / Locations
- Eskenazi Health
- Indiana University Health Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
TEG
Light transmittance aggregometry
Arm Description
Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69
Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%
Outcomes
Primary Outcome Measures
Thrombelastography (TEG) MA
Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel
Secondary Outcome Measures
Number of Participants With Ischemic Events
Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention
Number of Participants With Bleeding Events
Major or Minor Bleeding according to TIMI criteria
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01612884
Brief Title
Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)
Official Title
Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis, Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TEG
Arm Type
Other
Arm Description
Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69
Arm Title
Light transmittance aggregometry
Arm Type
Other
Arm Description
Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Intervention Description
Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
Primary Outcome Measure Information:
Title
Thrombelastography (TEG) MA
Description
Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Number of Participants With Ischemic Events
Description
Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention
Time Frame
6 months
Title
Number of Participants With Bleeding Events
Description
Major or Minor Bleeding according to TIMI criteria
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Eskenazi Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana University Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)
We'll reach out to this number within 24 hrs