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

• Status: Terminated
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Schering-Plough
• Treatments: Eptifibatide

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