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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

January 7, 2008
July 24, 2012
November 2007
November 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00719914 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Safety/Efficacy Study of Intracoronary Integrilin to Improve Balloon Angioplasty Outcomes for the Treatment of Heart Attacks
IntraCoronary Treatment With Integrilin To Improve ANgiographic Outcomes (IC TITAN - TIMI 47) Trial

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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
ST-Elevation Myocardial Infarction
  • Drug: eptifibatide
    Intra-coronary injection, weight based, of eptifibatide.
  • Drug: eptifibatide
    Intra-coronary injection, based on weight, of eptifibatide
  • Drug: normal saline
    Intra-coronary injection, weight based, of normal saline.
  • Active Comparator: 1
    Intracoronary injection of eptifibatide
    Interventions:
    • Drug: eptifibatide
    • Drug: eptifibatide
  • Placebo Comparator: 2
    Intra-coronary injection of normal saline.
    Intervention: Drug: normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
31
January 2009
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00719914
T101
Yes
C. Michael Gibson, MS, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
Schering-Plough
Study Chair: Eugene Braunwald, M.D. TIMI Study Group
Principal Investigator: C. Michael Gibson, M.D. TIMI Study Group
Brigham and Women's Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP