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

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

History of Changes

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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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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6. Secondary:

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

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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 ]

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8. Secondary:

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

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9. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Principal Investigator shall furnish Sponsor with copy of any proposed publication for review/comment prior to submission for publication, at least thirty (30) days prior to submission for manuscripts and at least fifteen (15) days prior to submission for abstracts. Institution agrees to delete information identified by Sponsor as Confidential Information prior to submission for publication.

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
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.

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

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