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

This study has been terminated.
(Poor enrollment)
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
C. Michael Gibson, MS, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00719914
First received: January 7, 2008
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
ST-Elevation Myocardial Infarction
Drug: eptifibatide
Drug: normal saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IntraCoronary Treatment With Integrilin To Improve ANgiographic Outcomes (IC TITAN - TIMI 47) Trial

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

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) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: November 2007
Study Completion Date: January 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719914

Locations
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
Schering-Plough
Investigators
Study Chair: Eugene Braunwald, M.D. TIMI Study Group
Principal Investigator: C. Michael Gibson, M.D. TIMI Study Group
  More Information

No publications provided

Responsible Party: C. Michael Gibson, MS, MD, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00719914     History of Changes
Other Study ID Numbers: T101
Study First Received: January 7, 2008
Results First Received: July 24, 2012
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
eptifibatide
Integrilin
ST-Elevation Myocardial Infarction
Acute Myocardial Infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Eptifibatide
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014