A Safety/Efficacy Study of Intracoronary Integrilin to Improve Balloon Angioplasty Outcomes for the Treatment of Heart Attacks (IC TITAN)

This study has been terminated.
(Poor enrollment)
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
C. Michael Gibson, MS, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00719914
First received: January 7, 2008
Last updated: July 24, 2012
Last verified: July 2012
Results First Received: July 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: ST-Elevation Myocardial Infarction
Interventions: Drug: eptifibatide
Drug: normal saline

  Participant Flow
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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
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Reporting Groups
  Description
Additional Bolus of Eptifibatide Intracoronary injection of eptifibatide
Bolus of Normal Saline Intracoronary injection of normal saline.

Participant Flow:   Overall Study
    Additional Bolus of Eptifibatide     Bolus of Normal Saline  
STARTED     10     7  
COMPLETED     10     7  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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
Additional Bolus of Eptifibatide Intracoronary injection of eptifibatide
Bolus of Normal Saline Intra-coronary injection of normal saline.
Total Total of all reporting groups

Baseline Measures
    Additional Bolus of Eptifibatide     Bolus of Normal Saline     Total  
Number of Participants  
[units: participants]
  10     7     17  
Age  
[units: years]
Mean ± Standard Deviation
  57.9  ± 10.2     67  ± 9.5     61.6  ± 10.7  
Age, Customized  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 75 years     9     6     15  
>=75 years     1     1     2  
Gender  
[units: participants]
     
Female     1     0     1  
Male     9     7     16  
Region of Enrollment  
[units: participants]
     
United States     10     7     17  



  Outcome Measures

1.  Primary:   Improvement in Percent Diameter Stenosis of the Culprit Artery Following the IC Bolus Administration of Eptifibatide vs. IC Placebo (Saline) as Assessed With Quantitative Coronary Angiography (QCA)   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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
Early termination due to poor enrollment.  


Results Point of Contact:  
Name/Title: C. Michael Gibson, MS, MD
Organization: Brigham and Women's Hospital
phone: 617-632-7753
e-mail: mgibson@perfuse.org


No publications provided


Responsible Party: C. Michael Gibson, MS, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00719914     History of Changes
Other Study ID Numbers: T101
Study First Received: January 7, 2008
Results First Received: July 24, 2012
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration