Problem Suspected acute MI
Format Multicenter, double-blinded, two-by-two factorial, randomized, placebo-controlled trial
Treatment Streptokinase OR Aspirin OR Both
Control Placebo
Population 17,187 patients
Inclusion criteria Suspected acute MI within 24 hours of symptom onset
No clear indication for, or contraindication to, streptokinase or aspirin
Exclusion criteria History of stroke
History of GI bleed or PUD
Recent arterial puncture
Recent severe trauma
Severe persistent hypertension
Allergy to streptokinase or aspirin
Follow-up 10 years (in most recent paper)
Primary endpoint Vascular mortality at 5 weeks
Secondary endpoint(s) Nonfatal reinfarction
Bleeds requiring transfusion
Nonfatal strokes
Cerebral hemorrhage
Details Randomized by 2x2 factorial design
-Streptokinase vs. placebo (infusion over 1 hour)
-Aspirin vs. placebo (oral for 1 month)
-->Four groups: streptokinase, aspirin, both, neither
Brief summary: Early evidence for aspirin and thrombolysis
PAPER: Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. ISIS-2 Collaborative Group.
Date 13 Aug 1988
Journal Lancet. 1988 Aug 13;2(8607):349-60.
Information Benefits:
-Streptokinase alone and aspirin alone give significant reduction in 5-week vascular mortality
-Significant different in vascular and all-cause mortality at 15 months
-Combination better than either agent alone
-Benefits even in treatment as late as 13-24 hours
-Aspirin significantly reduced non-fatal reinfarction with no increased bleeding risk
-Streptokinase associated with excess of
--Bleeds requiring transfusion
--Intracranial haemorrhage
--Non-fatal reinfarction if used alone
PAPER: Reduction in incidence of inducible ventricular tachycardia after myocardial infarction by treatment with streptokinase during infarct evolution.
Date 16 Dec 1990
Journal J Am Coll Cardiol. 1990 Dec;16(7):1703-10.
Information Electrophysiological testing in 87 patients
-Streptokinase substantially reduced the incidence of inducible ventricular tachycardia in infarct survivors
-No such benefit from aspirin
PAPER: ISIS-2: 10 year survival among patients with suspected acute myocardial infarction in randomised comparison of intravenous streptokinase, oral aspirin, both, or neither.
Date 2 May 1998
Journal BMJ. 1998 May 2;316(7141):1337-43.
Information Survival advantages produced by fibrinolytic therapy and one month of aspirin started in acute myocardial infarction seem to be maintained for at least 10 years.