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

Clinical Topics: Anticoagulation Management, Dyslipidemia, Lipid Metabolism, Novel Agents

Keywords: Thrombolytic Therapy, Myocardial Infarction, Stroke, Urokinase-Type Plasminogen Activator, Recombinant Proteins, Fibrinolytic Agents


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