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

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ClinicalTrials.gov Identifier: NCT01612884
Recruitment Status : Terminated (Slow enrollment)
First Posted : June 6, 2012
Results First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Rolf Kreutz, Indiana University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Thrombosis
Coronary Artery Disease
Interventions: Drug: Prasugrel
Drug: Clopidogrel

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
67 subjects were enrolled and underwent testing on day 0. Only 37 of those subjects underwent PCI, and therefore were randomized to either LTA or TEG guided intervention arm. The remainder of subjects were treated medically without PCI or were referred for CABG (see flow diagram in protocol) and did not get randomized to any intervention arm.

Reporting Groups
  Description
Thrombelastography (TEG) Guided

Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69

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

Light Transmittance Aggregometry Guided

Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%

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


Participant Flow:   Overall Study
    Thrombelastography (TEG) Guided   Light Transmittance Aggregometry Guided
STARTED   19   18 
COMPLETED   19   18 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Thrombelastography (TEG) Guided

Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69

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

Light Transmittance Aggregometry Guided

Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%

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

Total Total of all reporting groups

Baseline Measures
   Thrombelastography (TEG) Guided   Light Transmittance Aggregometry Guided   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   18   37 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.2  (9.8)   53.2  (10.5)   54.2  (10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  26.3%      10  55.6%      15  40.5% 
Male      14  73.7%      8  44.4%      22  59.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      14  73.7%      8  44.4%      22  59.5% 
White      5  26.3%      10  55.6%      15  40.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   19   18   37 


  Outcome Measures

1.  Primary:   Thrombelastography (TEG) MA   [ Time Frame: 1 day ]

2.  Secondary:   Number of Participants With Ischemic Events   [ Time Frame: 6 months ]

3.  Secondary:   Number of Participants With Bleeding Events   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Rolf Kreutz, MD
Organization: Indiana University School of Medicine
phone: 3179620500
e-mail: rkreutz@iu.edu



Responsible Party: Rolf Kreutz, Indiana University
ClinicalTrials.gov Identifier: NCT01612884     History of Changes
Other Study ID Numbers: 1106005745
First Submitted: June 4, 2012
First Posted: June 6, 2012
Results First Submitted: December 29, 2017
Results First Posted: April 26, 2018
Last Update Posted: April 26, 2018