Anglo-Scandinavian Study of Early Thrombolysis - ASSET

Jul 10, 2003
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Date Published:
01/01/1988
Date Updated:
07/10/2003
Original Posted Date:
07/10/2003
References

Description:

ASSET was the first large scale trial to compare mortality with rt-PA vs placebo in patients with suspected acute MI.

Hypothesis:

Mortality at 1 month would be relatively 20% reduced in rt-PA patients compared with placebo patients.

Study Design

Study Design:

Patients Screened: 13,318
Patients Enrolled: 5,011
Mean Follow Up: 6 months
Mean Patient Age: not reported
Female: 23

Patient Populations:

Age 18-75 Suspected acute MI (no ECG criteria required) Time from onset of symptoms to treatment <=5 hours.

Exclusions:

History of any major hemorrhage or stroke in prior 6 months; major injury or surgery in previous 6 weeks; CPR on admission; systolic blood pressure >200 mmHg; known bleeding disorder; treatment with anicoagulants at time of admission; proliferative diabetic retinopathy; active peptic ulcer; possibility of pregnancy; know sensitivity to gentamicin.

Primary Endpoints:

All cause mortality at 30 days

Secondary Endpoints:

Major bleed Stroke Recurrent MI Ventricular arrhythmias Cardiogenic shock Heart failure

Drug/Procedures Used:

rt-PA, 10 mg bolus + 50 mg infusion in 1 hr + 20 mg infusion in each of next 2 hours matching placebo.

Concomitant Medications:

Heparin, 5000 U IV bolus + infusion of 1000 U/h for 21 hours

Principal Findings:

The 1 month the mortality rate was 7.2% in the rt-PA arm and 9.8% in the placebo arm (p=0.001), a relative reduction of 26%. At 6 months the mortality rate was 10.4% in the rt-PA arm and 13.1% in the placebo arm (p=0.0026), a relative reduction of 21%. Major bleeding was slightly higher in patients given rt-PA compared with placebo (1.4% vs 0.8%). The incidence of stroke was similar in the two groups (1.1% vs 1.0% in the placebo group). Subset analysis showed that in patients with an abnormal ECG at entry, rt-PA was associated with a 24.5% relative reduction in 1 month fatality (8.5% vs 11.2%) and with a 26% relative reduction in 6 month fatality (12.6% vs 17.1%).

Interpretation:

ASSET was the first large scale trial to show a short- and long-term mortality reduction with rt-PA over placebo in patients with suspected acute MI. The 26% mortality reduction with rt-PA was similar to trials for streptokinase during the same time period (ISAM, GISSI, ISIS-2). As a result of these trials, GISSI-2 and GUSTO were designed to compare rt-PA and streptokinase directly.

References:

Lancet 1988 Sep 3;2(8610):525-530. (Main results) Lancet 1990 May 19;335(8699):1175-1178. (6-month results)

Keywords: Stroke, Streptokinase, Fibrinolysis, Coronary Disease, Fibrinolytic Agents, Electrocardiography, Tissue Plasminogen Activator, Hemorrhage


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