Status:
TERMINATED
A Safety/Efficacy Study of Intracoronary Integrilin to Improve Balloon Angioplasty Outcomes for the Treatment of Heart Attacks
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Schering-Plough
Conditions:
ST-Elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 ini...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00719914
Start Date
November 1 2007
End Date
January 1 2009
Last Update
August 27 2012
Active Locations (3)
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1
Cardiology Research Associates
Ormond Beach, Florida, United States, 32174
2
Crittenton Hospital Medical Center
Rochester, Michigan, United States, 48307
3
Mid Ohio Heart Clinic
Mansfield, Ohio, United States, 44906