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

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Rolf Kreutz, Indiana University
ClinicalTrials.gov Identifier:
NCT01612884
First received: June 4, 2012
Last updated: April 1, 2016
Last verified: April 2016
  Purpose
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

Condition Intervention Phase
Thrombosis
Coronary Artery Disease
Drug: Prasugrel
Drug: Clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Thrombelastography (TEG) MA [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel


Secondary Outcome Measures:
  • Ischemic events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention

  • Bleeding events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 67
Study Start Date: August 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612884

Locations
United States, Indiana
Eskenazi Health
Indianapolis, Indiana, United States, 46202
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
  More Information

Responsible Party: Rolf Kreutz, M.D., Assistant Professor of Clinical Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT01612884     History of Changes
Other Study ID Numbers: 1106005745 
Study First Received: June 4, 2012
Last Updated: April 1, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Thrombosis
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Embolism and Thrombosis
Clopidogrel
Ticlopidine
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 21, 2016