A Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study to assess the safety and efficacy of a single subcutaneous injection of zalunfiban in subjects with ST-elevation myocardial infarction in the pre-hospital setting

in whom the total duration of symptoms to diagnostic ECG is anticipated to be within 4 hours., presenting with persistent ischemic chest pain (>10 minutes) and new ≥2 mm ST-segment elevation in 2 adjacent ECG leads, Subjects with documented STEMI

Efficacy: Clinical outcome as assessed on a 7-point scale; ranked from worst to best: 7. Death (all cause) within 30 days of randomization, 6. Stroke within 30 days of randomization, 5. Recurrent MI (yypes 1 to 4 MI) within 30 days of randomization, 4. Acute stent thrombosis within 24 hours post-PCI/angiography, 3. New onset HF or re-hospitalization for HF within 30 days of randomization, 2. MI with hs-cTnT levels ≥30 × ULN within 24 hours +/- 12 hours post study drug admin, 1. None of the above, Saferty: Subject incidence of bleeding events (according to GUSTO severe or life-threatening criterion for safety assessment and, for information only, according to the BARC Types 3C and 5 criteria) at 30-day follow-up

Efficacy: To assess after a single subcutaneous injection of zalunfiban versus placebo: As assessed by an independent Core Laboratory: Corrected TIMI Frame Count of the Infarct-Related Artery (Culprit) before PCI/angiography, Efficacy: To assess after a single subcutaneous injection of zalunfiban versus placebo: As assessed by an independent Core Laboratory: ST-segment deviation resolution 1-hour post-PCI/angiography, Efficacy: To assess after a single subcutaneous injection of zalunfiban versus placebo: Blinded bail-out use of IV αIIbβ3 receptor antagonists or IV P2Y12 antagonists at 24 hours post-PCI/angiography, Safety: To assess after a single subcutaneous injection of zalunfiban versus placebo: Recording of AEs and SAEs. AEs up to 30-day follow-up; SAEs up to resolution/stabilization, the SAEs mortality, hospitalization for HF and atrial fibrillation up to 12-month follow-up, Safety: To assess after a single subcutaneous injection of zalunfiban versus placebo: Platelet count before PCI/angiography, at the end of the PCI/angiography, 6 and 24 hours post-PCI/angiography and at hospital discharge/72-hours post-PCI/angiography (whichever occurs first), Safety: To assess after a single subcutaneous injection of zalunfiban versus placebo: Subject incidence of bleeding events (according to ISTH Major and, for information only, TIMI Major) at 30-day follow-up, Safety: To assess after a single subcutaneous injection of zalunfiban versus placebo: Subject incidence of bleeding events according to GUSTO mild and moderate criteria, BARC Types 2, 3, and 5 criteria, ISTH minor and or major bleeding, TIMI minor and major criteria at 30-day follow-up, Safety: To assess after a single subcutaneous injection of zalunfiban versus placebo: Subject incidence of injection site reactions at baseline, 1-hour post-PCI/angiography, hospital discharge/72-hours post-PCI/angiography, and at 30-day follow-up

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