A Safety/Efficacy Study of Intracoronary Integrilin to Improve Balloon Angioplasty Outcomes for the Treatment of Heart Attacks
Condition: ST-Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Intervention: eptifibatide; eptifibatide; normal saline
Intervention description: Intra-coronary injection, weight based, of eptifibatide.; Intra-coronary injection, based on weight, of eptifibatide; Intra-coronary injection, weight based, of normal saline.
Intervention MeSH terms: Eptifibatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: eptifibatide; Integrilin; ST-Elevation Myocardial Infarction; Acute Myocardial Infarction

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.
    

Eligibility 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