ST-Elevation Myocardial Infarction Clinical Trial
— IC TITANOfficial title:
IntraCoronary Treatment With Integrilin To Improve ANgiographic Outcomes (IC TITAN - TIMI 47) Trial
Verified date | July 2012 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 31 |
Est. completion date | January 2009 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mid Ohio Heart Clinic | Mansfield | Ohio |
United States | Cardiology Research Associates | Ormond Beach | Florida |
United States | Crittenton Hospital Medical Center | Rochester | Michigan |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Schering-Plough |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 30 days | No |
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