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

Stopped early · Phase 2

Conditions studied: ST-Elevation Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT00719914

Run by

Brigham and Women's Hospital

People needed

31

Starts

2007-11-01

Expected to finish

2009-01-01

Last updated by the study team

2012-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cardiology Research Associates — Ormond Beach, Florida, United States
• Crittenton Hospital Medical Center — Rochester, Michigan, United States
• Mid Ohio Heart Clinic — Mansfield, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.