A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI

Prior treatment

• Currently treated with renal dialysis.
• Current treatment with oral anticoagulation (Vitamin K antagonists \[VKA\], direct oral anticoagulants \[DOACs\]), or thrombolytic agents.
• Previously enrolled in this study.
• Participation in another clinical study with an investigational product or device within the past month.

Other illness

• Cardio Pulmonary Resuscitation (CPR) for current Out of Hospital Cardiac Arrest (OHCA).
• Presenting with systolic blood pressure \<90 mmHg (confirmed on repeat assessment) and heart rate \>100 beats per minute (bpm).
• Current known active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines).
• Major surgery, or trauma or bleeding leading to hospitalization, within the past month.
• Known history of ischemic or hemorrhagic stroke.

Other

• Known severe anemia (regular blood transfusion needed).
• Life expectancy less than one year.
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• Males aged ≥18 years or post-menopausal or surgically sterile females ≥50 years or ≥55 years (for Czech Republic study sites only).
• Weight (by history) between 52 and 130 kg.
• Subjects with STEMI, presenting with persistent ischemic chest pain (\>10 minutes) and new ≥2 mm ST-segment elevation in two adjacent ECG leads, in whom the total duration of symptoms is 4 hours maximum. If time of symptom onset is uncertain, the cardiologist may be contacted to confirm inclusion criteria.
• Exception from Informed Consent Requirements (EFIC) process, verbal witnessed/ short written informed consent, or written informed consent signed by subject or legally authorized representative/independent witness will be obtained in the acute phase by (para)medics, according to local applicable legal regulations. Subject is willing and able to give informed consent. Written informed consent will be obtained as soon as the subject's clinical condition allows it.