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Bolus Versus Infusion in Rescupase (Saruplase) Development - BIRD
Description:
Bolus vs. continuous saruplase for 30-day mortality in acute MI.
Hypothesis:
To test the equivalence of clinical efficacy and safety of two methods of administering saruplase, a thrombolytic agent.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 2,410
Patient Populations:
Acute MI within 6 hours
No contraindication for thrombolysis
ST segment elevation of at least 0.1 mV in 2 frontal plane leads or at least 0.2 mV in 2 precordial leads
Primary Endpoints:
Mortality within 30 days
Secondary Endpoints:
Inadequate outcome, including stroke and severe bleeding
Drug/Procedures Used:
Saruplase, 20mg bolus, followed by 60mg infusion over one hour vs. Saruplase, 80mg bolus.
Principal Findings:
The death rate was 5.9% for the bolus group and 6.0% for the standard group.
The reinfarction rate was 6.5% for the bolus group and 5.0% for the standard group.
Recurrent angina was experienced by 24.7% of the bolus group and 25.9% of the standard group.
The hemorrhagic stroke rate was 0.8% for the bolus group and 0.7% for the standard group, and the thromboembolic stroke rate was 0.7% for the bolus group and 0.9% for the standard group.
Severe bleeding was experienced by 2.8% of the bolus group and 2.4% of the standard group.
Interpretation:
In previous studies, saruplase was administered as a bolus of 20mg followed by an infusion of 60mg in one hour. As a result of a pilot study, investigators determined that the BIRD study would test a single bolus of 80mg, which might be more practical in some cases, against this standard regimen. The 30 day results suggest that the two dosing strategies are equivalent.
References:
Presented at the XXth Congress of the European Society of Cardiology, Vienna, 1998
Keywords: Thrombolytic Therapy, Myocardial Infarction, Stroke, Urokinase-Type Plasminogen Activator, Recombinant Proteins, Fibrinolytic Agents
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