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ISIS-2 TRIAL |
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| 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. | |
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| 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 Risks: -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. |