RETAVASE® (reteplase) is a recombinant plasminogen activator which catalyzes the cleavage of endogenous plasminogen to generate plasmin. Plasmin degrades the fibrin matrix of the thrombus, exerting its thrombolytic action.
Established safety profile in clinical trials
RAPID 21
RAPID 2 was designed to detect differences in patency and was not powered to detect differences in adverse clinical outcomes.
The composite endpoint of unsatisfactory outcomes* ≤35 days after treatment was observed in 21.3% of patients in the RETAVASE 10 + 10 unit group.
*The composite endpoint of unsatisfactory outcomes included death, reinfarction, congestive heart failure, or shock and/or an ejection fraction of <40% at predischarge evaluation.
RAPID 13
RAPID 1 was designed to detect differences in patency and was not powered to detect differences in adverse clinical outcomes.
INJECT4,5
- In INJECT, the noninferiority trial for RETAVASE conducted in Europe, the overall rate of in-hospital intracranial hemorrhage for RETAVASE was 0.8% (n=2,965)
- An exploratory analysis indicated that the incidence of intracranial hemorrhage was higher among:
- Patients >70 years old: 2.2%
- Patients with systolic blood pressure >160 mmHg: 2.4%
Other types of hemorrhage across clinical trials4
- Severity and sites of other types of bleeding were similar for RETAVASE and the comparison thrombolytic agents
- The incidence of other types of bleeding events with RETAVASE in clinical studies varied depending on:
- The use of arterial catheterization or other invasive procedures (RAPID studies)
- Site-specific protocol differences (Europe vs US)