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

Primary Purpose

ST-Elevation Myocardial Infarction

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
eptifibatide
eptifibatide
normal saline
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-Elevation Myocardial Infarction focused on measuring eptifibatide, Integrilin, ST-Elevation Myocardial Infarction, Acute Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical

  • Patients (men or women) at least 18 years of age and
  • Presenting with ischemic chest discomfort >20 minutes and <6 hours of duration suggestive of acute myocardial infarction

AND:

ECG

  • ST elevation >1mm (>0.1mV) in two contiguous limb leads OR >2mm (>0.2mV) in two contiguous precordial leads

Exclusion Criteria:

CLINICAL

  • Maximal systolic blood pressure <80 mmHg AFTER initial fluid and/or pressor resuscitation
  • Uncontrolled hypertension (SBP>180 OR DBP >110) at time of enrollment
  • Ventricular fibrillation or ventricular tachycardia requiring DC cardioversion
  • Sinus bradycardia (HR <50/min), third degree or advanced second degree heart block.
  • Known pregnancy
  • New or suspected new left bundle branch block

BIOCHEMICAL

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

INCREASED BLEEDING RISK

  • Active or recent (<1 year) bleeding or gastrointestinal hemorrhage
  • Major surgery <1 month
  • Known coagulopathy, platelet disorder or history of thrombocytopenia: If a patient is known to be on chronic warfarin therapy, the International Normalized Ratio (INR) must be known to be <1.6 in order for the patient to be included
  • Known neoplasm
  • Any history of hemorrhagic cerebrovascular disorder or active intracranial pathology

MEDICATIONS

  • Administration of a fibrinolytic agent within 7 days
  • Known allergy or contraindication to eptifibatide OR aspirin OR heparin
  • Treatment with another GP IIb/IIIa inhibitor within 7 days

Sites / Locations

  • Cardiology Research Associates
  • Crittenton Hospital Medical Center
  • Mid Ohio Heart Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Intracoronary injection of eptifibatide

Intra-coronary injection of normal saline.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
January 7, 2008
Last Updated
July 24, 2012
Sponsor
Brigham and Women's Hospital
Collaborators
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00719914
Brief Title
A Safety/Efficacy Study of Intracoronary Integrilin to Improve Balloon Angioplasty Outcomes for the Treatment of Heart Attacks
Acronym
IC TITAN
Official Title
IntraCoronary Treatment With Integrilin To Improve ANgiographic Outcomes (IC TITAN - TIMI 47) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Schering-Plough

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this research study is to try to improve the results of the standard treatment for heart attacks. Normally, heart attack patients get a fast dose and a slow dose of eptifibatide in the emergency room, shortly after arriving. This drug is usually given through a vein in the arm. However, eptifibatide can also be injected directly into the heart's blood supply just before angioplasty, a common procedure to unblock a blood vessel in the heart. This new way of giving the drug is being studying.
Detailed Description
The primary objective of the IC-TITAN study is to demonstrate that an IC bolus of eptifibatide added to an upstream double-bolus and infusion regimen of eptifibatide administered intravenously and initiated early in the ER will result in significant additional clot resolution in vivo when compared with an IC injection of placebo (saline). The primary endpoint chosen to evaluate this hypothesis is the 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-Elevation Myocardial Infarction
Keywords
eptifibatide, Integrilin, ST-Elevation Myocardial Infarction, Acute Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Intracoronary injection of eptifibatide
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Intra-coronary injection of normal saline.
Intervention Type
Drug
Intervention Name(s)
eptifibatide
Intervention Description
Intra-coronary injection, weight based, of eptifibatide.
Intervention Type
Drug
Intervention Name(s)
eptifibatide
Intervention Description
Intra-coronary injection, based on weight, of eptifibatide
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
Intra-coronary injection, weight based, of normal saline.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical Patients (men or women) at least 18 years of age and Presenting with ischemic chest discomfort >20 minutes and <6 hours of duration suggestive of acute myocardial infarction AND: ECG ST elevation >1mm (>0.1mV) in two contiguous limb leads OR >2mm (>0.2mV) in two contiguous precordial leads Exclusion Criteria: CLINICAL Maximal systolic blood pressure <80 mmHg AFTER initial fluid and/or pressor resuscitation Uncontrolled hypertension (SBP>180 OR DBP >110) at time of enrollment Ventricular fibrillation or ventricular tachycardia requiring DC cardioversion Sinus bradycardia (HR <50/min), third degree or advanced second degree heart block. Known pregnancy New or suspected new left bundle branch block BIOCHEMICAL Known thrombocytopenia (platelet count <100,000) Known severe renal insufficiency (creatinine >4.0 mg/dL) INCREASED BLEEDING RISK Active or recent (<1 year) bleeding or gastrointestinal hemorrhage Major surgery <1 month Known coagulopathy, platelet disorder or history of thrombocytopenia: If a patient is known to be on chronic warfarin therapy, the International Normalized Ratio (INR) must be known to be <1.6 in order for the patient to be included Known neoplasm Any history of hemorrhagic cerebrovascular disorder or active intracranial pathology MEDICATIONS Administration of a fibrinolytic agent within 7 days Known allergy or contraindication to eptifibatide OR aspirin OR heparin Treatment with another GP IIb/IIIa inhibitor within 7 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Braunwald, M.D.
Organizational Affiliation
TIMI Study Group
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
C. Michael Gibson, M.D.
Organizational Affiliation
TIMI Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology Research Associates
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Crittenton Hospital Medical Center
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Mid Ohio Heart Clinic
City
Mansfield
State/Province
Ohio
ZIP/Postal Code
44906
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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