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 States, Canada, Czechia2,463 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 3 trial specifically for STEMI — a very serious, time-sensitive type of heart attack — how does joining this study affect the speed and type of emergency care I would receive compared to standard treatment?
2This trial is measuring both clinical outcomes and bleeding events using something called BARC criteria — can you explain what the main bleeding risks of zalunfiban look like in practice, and how serious those risks might be for someone in my situation?
3The trial is still active but no longer enrolling new participants — does that mean there's any realistic chance I could still be considered, or should we focus entirely on other treatment options available to me right now?
4Since zalunfiban is being studied as a treatment during STEMI, how does it compare to the clot-preventing medications I would already receive as part of standard emergency heart attack care, and would I still get those standard treatments if I were in this trial?
5Given that this is a Phase 3 study — which means it's further along in testing — what do you know so far about how well zalunfiban appears to be working, and does any of that early information change how you'd approach my treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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