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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: September 20, 2016
Last verified: September 2016

June 4, 2012
September 20, 2016
August 2011
December 2016   (final data collection date for primary outcome measure)
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
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
Complete list of historical versions of study NCT01612884 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)
Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)
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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Thrombosis
  • Coronary Artery Disease
  • 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
  • TEG
    Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69
    Interventions:
    • Drug: Prasugrel
    • Drug: Clopidogrel
  • Light transmittance aggregometry
    Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%
    Interventions:
    • Drug: Prasugrel
    • Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
67
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Both
21 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01612884
1106005745
Not Provided
Not Provided
Not Provided
Rolf Kreutz, Indiana University
Indiana University
Not Provided
Not Provided
Indiana University
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP