Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI (ERASE-MI)

Portola Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Myocardial Infarction

Treatments

Drug: placebo

Drug: PRT060128 Potassium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00546260

07-113

Details and patient eligibility

About

Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)

Full description

Patients with STEMI who are to undergo primary PCI will be randomized to an intravenous (iv) bolus of placebo vs. PRT060128 prior to angiography.

Enrollment

70 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

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 -- History or symptoms of a congenital or acquired bleeding disorder or vascular malformation.
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.