drugset / Trial / NCT07146360
Efficacy and Safety Study of Proposed Biosimilar Product Reveliza vs Actilise in Patients With ST-segment Elevation Myocardial Infarction
RandomizedParallel-groupSingle-blindTreatment
Summary
Thi is is a multi-center, randomized, single-blind, parallel group clinical trial to evaluate the efficacy and safety of the intravenious thrombolysis with Revelise® (GENERIUM, Russia) in comparosin with the Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany) in patients with acute myocardial infarction (MI) with ST-segment elevation on the electrocardiogram (ECG). The thrombolisis was performed within the period of up to 6 hours and from 6 to 12 hours from the MI symptoms onset.
Timeline
- Start
- 2014-05-25
- Primary completion
- 2017-11-21
- Completion
- 2017-12-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alteplase | Protein / enzyme biologic | 1.5 mg/kg | Intravenous |
| Comparator | Alteplase | Protein / enzyme biologic | 100 mg | Intravenous |
| Subject | Revelise | Protein / enzyme biologic | 1.5 mg/kg | Intravenous |
| Subject | Revelise | Protein / enzyme biologic | 100 mg | Intravenous |