A Randomized Trial to Evaluate the Effect of Adjunctive Antiplatelet Therapy with Intravenous PRT060128, a Selective P2Y12-Receptor Inhibitor, Before Primary Percutaneous Intervention in Patients with ST-Elevation Myocardial Infarction - ERASE-MI

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 220

Inclusion Criteria

·Persistent ST elevation = 1mm (= 0.1mV) in two contiguous limb leads OR = 2 mm (= 0.2mV) in two contiguous precordial leads, AND chest pain = 20 minutes with onset within 6 hours of hospital presentation.
·The subject is at least 18 years of age and willing to comply with protocol.
·If the subject is a woman, she is without reproductive potential (postmenopausal for = 2 years, after hysterectomy, or consistently using a reliable barrier method or an acceptable form of birth control).
·The subject or legally acceptable representative is able to read and give written informed consent and has signed an informed consent form approved by the Investigator's IRB/IEC.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Cardiogenic shock (systolic blood pressure < 90 mm Hg requiring vasopressor or hemodynamic support)
·Uncontrolled hypertension defined as any measured systolic blood pressure (SBP) = 180 mm Hg or diastolic blood pressure (DBP) = 110 mm Hg after the time of first medical contact for the presenting STEMI event.
·New or old left bundle branch block.
·Paced cardiac rhythm.
·Previous coronary artery bypass grafting.
·Ventricular fibrillation or ventricular tachycardia requiring cardioversion or defibrillation.
·Advanced 2nd or 3rd degree heart block.
·History or symptoms of a congenital or acquired bleeding disorder or vascular malformation.
·History of any prior ischemic stroke or intracranial hemorrhage, neoplasm, or arteriovenous malformation.
·History of any TIA symptoms within the past 12 months.
·Recent facial or head trauma within the last 30 days.
·Recent intraocular hemorrhage within the last 30 days.
·Recent gastrointestinal bleeding within the last 30 days.
·Known thrombocytopenia (platelet count < 100,000/mm3).
·Any treatment with a fibrinolytic agent within the last 7 days.
·Known allergy or contraindication to the components of PRT060128, aspirin, heparin, clopidogrel, glycoprotein IIb/IIIa inhibitors, or to any contrast media.
·Received oral anticoagulants (eg, warfarin) within the last 7 days.
·Participation in any investigational drug study 30 days prior to enrollment is prohibited. Participation in a device trial prior to enrollment is acceptable.
·Any condition which could interfere with or for which the treatment of might interfere with the conduct of the study, or which would, in the opinion of the Investigator, unacceptably increase the risk of the subject's participation in the study. This would include, but is not limited to alcoholism, drug dependency or abuse, psychiatric disease, epilepsy, or any unexplained blackouts.
·Prior participation in ERASE MI study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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