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GISSI-3 TRIAL |
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| Problem | AMI and preserved LVEF |
| Format | Multicenter, open label, 2x2 factorial design, randomized trial |
| Treatment | Lisinopril OR GTN (IV->PO) OR both |
| Control | Placebo |
| Population | 19,394 patients |
| Inclusion criteria | Typical chest pain accompanied by ST changes, either: ->1mm ST elevation or depression in ≥1 limb leads ->2mm ST elevation or depression in ≥1 chest leads Admitted to CCU within 24h of symptom onset |
| Exclusion criteria | Severe CHF requiring any of study drugs Killip class 4 High risk of further serious hemodynamic deterioration after treatment with vasodilators, judged by SBP <100 mmHg Contraindications to study drugs: -History of renal failure (creatinine > 2mg/dl, proteinuria >500mg/24h, or both) -History of bilateral renal artery stenosis -Documented allergy to study drug -Other life-threatening disorders |
| Follow-up | 6 months |
| Primary endpoint | Mortality at 6 weeks Composite of death, CHF, LVEF â‰_35%, ≥45% akinesis/dyskinesis |
| Secondary endpoint(s) | Clinical CHF LVEF >35% >45% akinesis/dyskinesis Reinfarction Post-infarction angina CABG PTCA SBP <90 mmHg for >1 h Cardiogenic shock Renal dysfunction Stroke |
| Details | - |
| Brief summary: | Lisinopril reduced mortality within 24h of AMI. No benefit from GTN. |
| PAPER: GISSI-3: effects of lisinopril and transdermal glyceryl trinitrate singly and together on 6-week mortality and ventricular function after acute myocardial infarction. | |
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| Date | 7 May 1994 |
| Journal | Lancet. 1994 May 7;343(8906):1115-22. |
| Information | -Lisinopril within 24h of AMI --Significantly reduced mortality @ 6w by 11% -No survival benefit from GTN -Benefits present in pre-defined high risk populations of females & those >70 years old |