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

Condition(s) studied

Investigational drug(s) / intervention(s)

zalunfiban: zalunfiban is a novel small molecule inhibitor of the platelet αIIbβ3 receptor specifically designed for first medical contact therapy of ST-elevation myocardial infarction (STEMI).

Placebo: A placebo will be prepared to those subjects assigned to placebo. Less than 1 mL (depending on subject's weight) will be administered by subcutaneous injection.

Study 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

Eligibility

Primary outcome measure(s)

• primary efficacy -clinical outcome — at 30 days follow-up after a single subcutaneous injection of zalunfiban versus placebo
  As assessed by a 7-point scale. The 7 outcomes, ranking from worst to best are: 1. Death (all cause) at 30 days follow-up 2. Stroke at 30 days follow-up 3. Recurrent MI (type 1 to 4 MI) at 30 days follow-up 4. Acute stent thrombosis at 24 hours post-PCI/angiography 5. New onset heart failure or rehospitalization for heart failure at 30 days follow-up 6. MI with hs-cTnT levels ≥30x ULN at 24 hours ± 12 hours post study drug administration 7. None of the above
• primary safety- bleeding events [BARC criteria] — after a single subcutaneous injection of zalunfiban versus placebo at 30 days post-PCI/angiography
  • To assess bleeding events (according to Global Use of Strategies to Open Occluded Coronary Arteries \[GUSTO\] severe or life threatening criterion for safety assessment and according to the Bleeding Academic Research Consortium \[BARC\] 3C and 5 criteria for information only)

Trial sites (45)

+ 5 more sites — see the full list on the official registry below.