A Safety/Efficacy Study of Intra-coronary Tenecteplase During Balloon Angioplasty to Treat Heart Attacks (ICE T-TIMI 49)

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
C. Michael Gibson, MS, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00604695
First received: January 7, 2008
Last updated: August 6, 2012
Last verified: August 2012
Results First Received: May 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Myocardial Infarction
Interventions: Drug: Tenecteplase
Drug: Sterile 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
The study randomized 40 primary percutaneous coronary intervention (PPCI) patients from 6 hospitals in the United States. The patients were given either a volume matched bolus of intracoronary (IC) tenecteplase (TNK) (4 mg; n=20) or IC saline placebo (4 mg; n=16) before and following PPCI. 4 subjects were randomized but did not receive 1st bolus.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Active Treatment Two (4mg) doses of tenecteplase
Placebo Control Two (4mL) doses of sterile saline

Participant Flow:   Overall Study
    Active Treatment     Placebo Control  
STARTED     20     20  
COMPLETED     20     16  
NOT COMPLETED     0     4  
Did not receive first bolus.                 0                 4  



  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
Active Treatment Two (4mg) doses of tenecteplase
Placebo Control Two (4mL) doses of sterile saline
Total Total of all reporting groups

Baseline Measures
    Active Treatment     Placebo Control     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     17     18     35  
>=65 years     3     2     5  
Age  
[units: years]
Mean ± Standard Deviation
  55.2  ± 7.6     55.6  ± 8.9     55.4  ± 8.2  
Gender  
[units: participants]
     
Female     5     3     8  
Male     15     17     32  
Region of Enrollment  
[units: participants]
     
United States     20     20     40  



  Outcome Measures
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1.  Primary:   Percent Diameter Stenosis of the Culprit Lesion Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention   [ Time Frame: Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention ]

2.  Secondary:   Number of Patients With Decrease in Thrombus Grade in the Culprit Artery Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention   [ Time Frame: Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention ]

3.  Secondary:   Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the Territory of the Culprit Artery Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug   [ Time Frame: Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug ]

4.  Secondary:   Measurements of Flow Velocity in the Culprit Artery in Terms of Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC)   [ Time Frame: Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug ]

5.  Secondary:   Number of Patients With Hyperemic Flow in the Culprit Artery. That is Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of Less Than 14   [ Time Frame: Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug ]

6.  Secondary:   Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minor Bleeding   [ Time Frame: Through 30days following PPCI ]

7.  Secondary:   Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minimal Bleeding   [ Time Frame: Through 30days following primary percutaneous coronary intervention ]

8.  Secondary:   Safety Endpoint: Number of Patients Who Developed Cardiac Arrhythmias   [ Time Frame: Through 30days following primary percutaneous coronary intervention ]

9.  Secondary:   Safety Endpoint: Number of Deaths   [ Time Frame: Through 30days following primary percutaneous coronary intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
This pilot study was not adequately powered to exclude a modest increase in bleeding events. Study drug could not be administered to 4 patients and 7 patients were excluded for not meeting the inclusion criteria of TIMI Flow Grade 0/1 at enrollment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: C. Michael Gibson, MS, MD
Organization: Brigham & 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: NCT00604695     History of Changes
Other Study ID Numbers: N3770S
Study First Received: January 7, 2008
Results First Received: May 15, 2012
Last Updated: August 6, 2012
Health Authority: United States: Food and Drug Administration