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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00719914
Recruitment Status : Terminated (Poor enrollment)
First Posted : July 22, 2008
Results First Posted : August 27, 2012
Last Update Posted : August 27, 2012
Information provided by (Responsible Party):
C. Michael Gibson, MS, MD, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
ST-Elevation Myocardial Infarction Drug: eptifibatide Drug: normal saline Phase 2

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IntraCoronary Treatment With Integrilin To Improve ANgiographic Outcomes (IC TITAN - TIMI 47) Trial
Study Start Date : November 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: 1
Intracoronary injection of eptifibatide
Drug: eptifibatide
Intra-coronary injection, weight based, of eptifibatide.

Drug: eptifibatide
Intra-coronary injection, based on weight, of eptifibatide

Placebo Comparator: 2
Intra-coronary injection of normal saline.
Drug: normal saline
Intra-coronary injection, weight based, of normal saline.

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  • 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



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

Exclusion Criteria:


  • 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


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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00719914

United States, Florida
Cardiology Research Associates
Ormond Beach, Florida, United States, 32174
United States, Michigan
Crittenton Hospital Medical Center
Rochester, Michigan, United States, 48307
United States, Ohio
Mid Ohio Heart Clinic
Mansfield, Ohio, United States, 44906
Sponsors and Collaborators
Brigham and Women's Hospital
Study Chair: Eugene Braunwald, M.D. TIMI Study Group
Principal Investigator: C. Michael Gibson, M.D. TIMI Study Group

Responsible Party: C. Michael Gibson, MS, MD, Principal Investigator, Brigham and Women's Hospital Identifier: NCT00719914     History of Changes
Other Study ID Numbers: T101
First Posted: July 22, 2008    Key Record Dates
Results First Posted: August 27, 2012
Last Update Posted: August 27, 2012
Last Verified: July 2012

Keywords provided by C. Michael Gibson, MS, MD, Brigham and Women's Hospital:
ST-Elevation Myocardial Infarction
Acute Myocardial Infarction

Additional relevant MeSH terms:
Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Platelet Aggregation Inhibitors