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

August 6, 2012 updated by: C. Michael Gibson, MS, MD

A Randomized Trial Evaluating Low-Dose IntraCoronary AdjunctivE Tenecteplase During Primary PCI for ST-Elevation Myocardial Infarction (ICE T)

The primary objective of this study is to gather preliminary data regarding the angiographic efficacy of the administration of low-dose adjunctive intracoronary (IC) tenecteplase during balloon angioplasty for heart attacks.

We hypothesize that low-dose IC tenecteplase will enhance the breakdown of blood clots at the site of the culprit lesion leading to reduced damage to the heart muscle.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to gather preliminary data regarding the angiographic efficacy of the administration of low-dose adjunctive intracoronary (IC) tenecteplase during primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Efficacy will be assessed by measurements of both the angiographic characteristics of the culprit lesion as well as by measurements of epicardial flow and myocardial perfusion in the territory of the infarct-related artery. This study will also evaluate the safety of administering low-dose IC tenecteplase to subjects undergoing primary PCI for STEMI treated with standard therapy (aspirin, clopidogrel, and glycoprotein IIb/IIIa inhibitors). Safety endpoints include the incidence of death, recurrent myocardial infarction (MI), abrupt vessel closure, subacute stent thrombosis, and TIMI major and minor bleeding events.

Prompt reperfusion therapy with primary PCI in patients with STEMI improves clinical outcomes through salvage of myocardial tissue. The proposed pilot trial is a randomized, placebo-controlled trial to evaluate the effectiveness and safety of adjunctive low-dose IC tenecteplase in conjunction with standard medical therapy during primary PCI for STEMI. We hypothesized that low-dose IC tenecteplase will enhance fibrinolysis at the site of the culprit lesion leading to reduced microvascular dysfunction. As reduced dose tenecteplase will be injected directly into the coronary artery increasing local concentration of the drug with minor systemic effects, an improved safety profile is also expected from this mode of administration.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 30501
        • Northeast Georgia Heart Center, Pc
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical Center
      • Decatur, Georgia, United States, 30033
        • Emory University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Rochester, Michigan, United States, 48307
        • Crittenton Hospital Medical Center
    • Nebraska
      • Freemont, Nebraska, United States, 68025
        • Heart Consultants, PC
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects (men or women) at least 18 years and less than 75 years of age and
  • Ischemic discomfort ≥20 minutes and ≤6 hours of duration and
  • ST elevation ≥1mm (≥0.1mV) in two contiguous limb leads OR ≥2mm (≥0.2mV) in two contiguous precordial leads and
  • Occluded infarct-related artery (TIMI Flow Grade 0 or 1) at the time of coronary angiography and
  • Planned primary PCI within 2 hours of hospital presentation and
  • Planned or concomitant use of aspirin, clopidogrel, unfractionated heparin, and Glycoprotein IIb/IIIa inhibition with intent to stent the infarct-related artery and
  • Informed consent able to be obtained

Exclusion Criteria:

CLINICAL

  • Age ≥75 years
  • Maximal systolic blood pressure <80 mmHg AFTER initial fluid and/or pressor resuscitation.
  • Uncontrolled hypertension (SBP >180 OR DBP >110) at time of enrollment.
  • Cardiac arrest or arrhythmia requiring chest compressions or cardiopulmonary resuscitation.
  • Known pregnancy.

BIOCHEMICAL

  • Known thrombocytopenia (platelet count <100,000)
  • Known severe renal insufficiency (creatinine >4.0 mg/dL).

INCREASED BLEEDING RISK

  • Active internal bleeding
  • Recent (<3 months) gastrointestinal hemorrhage
  • Recent intracranial or intraspinal surgery, trauma, major surgery, or biopsy of a parenchymal organ (< 1 month)
  • Known coagulopathy, platelet disorder, or history of thrombocytopenia
  • Current warfarin therapy
  • Known neoplasm
  • Any known history of transient ischemic attack, cerebrovascular accident, or active intracranial pathology including arteriovenous malformation or aneurysm

MEDICATIONS

  • Administration of a fibrinolytic agent within 72 hours
  • Known allergy or contraindication to fibrinolytics OR aspirin OR heparin OR clopidogrel

ANGIOGRAPHIC

  • Left Main Coronary artery culprit lesion
  • Ostial culprit lesion (ostium of LAD, LCX, or RCA).
  • Lesion in non-native coronary artery (e.g. saphenous vein graft, arterial conduit graft)
  • Subjects requiring urgent coronary artery bypass grafting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Two (4mg) doses of tenecteplase
Drug: Tenecteplase
Intracoronary injection of IV tenecteplase.
Placebo Comparator: 2
Two (4mL) doses of sterile saline
Drug: Sterile Saline
Intracoronary injection of IV sterile saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention
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
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
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
Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) in the culprit artery
Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug
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
Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of less than 14
Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug
Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minor Bleeding
Time Frame: Through 30days following PPCI
Through 30days following PPCI
Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minimal Bleeding
Time Frame: Through 30days following primary percutaneous coronary intervention
Through 30days following primary percutaneous coronary intervention
Safety Endpoint: Number of Patients Who Developed Cardiac Arrhythmias
Time Frame: Through 30days following primary percutaneous coronary intervention
Through 30days following primary percutaneous coronary intervention
Safety Endpoint: Number of Deaths
Time Frame: Through 30days following primary percutaneous coronary intervention
Through 30days following primary percutaneous coronary intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C. Michael Gibson, MS, MD

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: C. Michael Gibson, MS, MD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 17, 2008

First Posted (Estimate)

January 30, 2008

Study Record Updates

Last Update Posted (Estimate)

September 7, 2012

Last Update Submitted That Met QC Criteria

August 6, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N3770S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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