A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI (NCT04825743) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI
United States2,463 participantsStarted 2021-04-24
Plain-language summary
This is a Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study. Subjects with STEMI will be enrolled in the ambulance if they meet all eligibility criteria. These subjects will be evaluated by (para)medics who transport the subjects to the participating hospitals in Europe and North America. Hospitals and ambulance services with experience in ambulance studies will be selected. Each subject will receive a single subcutaneous injection containing either Disaggpro(tm) zalunfiban Dose 1 (0.110 mg/kg) or Disaggpro(tm) zalunfiban Dose 2 (0.130 mg/kg) or placebo
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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).
What they're measuring
1
primary efficacy -clinical outcome
Timeframe: at 30 days follow-up after a single subcutaneous injection of zalunfiban versus placebo
2
primary safety- bleeding events [BARC criteria]
Timeframe: after a single subcutaneous injection of zalunfiban versus placebo at 30 days post-PCI/angiography