Summary:
Evaluated lisinopril versus transdermal glyceryl trinitrate individually and both combined for 6 week mortality after acute myocardial infarction. Lisinopril when given within 24 hours of acute MI reduced mortality by 11% at 6 weeks. No benefit for transdermal glyceryl trinitrate. This led to the use of ACE inhibitors for acute myocardial infarction patients.
Original Publication:
Lancet. 1994 May 7;343(8906):1115-22.
Trial Details:
Eponym: Gruppo Italiano per lo Studio della Sopravvivenza nell’infarcto Micardico.
Purpose: To evaluate the use of ACE inhibitors after myocardial infarction on mortality both individually and in combination with transdermal glyceryl trinitrate.
Format: Double blind, multicenter, randomized, placebo controlled
Treatment Group: Either lisinopril or combination of lisinopril and transdermal glyceryl trinitrate
Control Group: Placebo
Number of Patients: 19.394
Inclusion Criteria: Typical anginal chest pains, symptoms < 24 hours and one the following ECG findings
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Limb leads ≥ 1 mm ST depression or elevation
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Precordial leads ≥ 2 mm ST depression or elevation
Exclusion Criteria:
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Severe congestive heart failure
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Killip Class IV
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Systolic blood pressure < 100 mmHg
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Contraindication for the study drugs (i.e. hyperkalemia, renal failure or allergy for lisinopril)
Follow-up: 6 months
Primary Endpoint:
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All-cause mortality at 6 weeks
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Composite of death, congestive heart failure, left ventricular ejection fraction < 35% or left ventricular ejection fraction > 45% with an akinetic or dyskinetic segment
Secondary Endpoint:
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Clinical heart failure
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Left ventricular ejection fraction < 35%
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Left ventricular ejection fraction > 45% with dyskinetic or akinetic segment
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Reinfarction
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Post-infarct angina
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Coronary revascularization (CABG or PTCA)
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Systolic blood pressure < 90 mmHg for > 1 hour
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Cardiogenic shock
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Renal dysfunction
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Stroke