Clinical Trials
GISSI-3
Trial Details:
Acronym: 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
- Limb leads ≥ 1 mm ST depression or elevation
- Precordial leads ≥ 2 mm ST depression or elevation
Exclusion Criteria:
- Severe congestive heart failure
- Killip Class IV
- Systolic blood pressure < 100 mmHg
- Contraindication for the study drugs (i.e. hyperkalemia, renal failure or allergy for lisinopril)
Follow-up: 6 months
Primary Endpoint:
- All-cause mortality at 6 weeks
- 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:
- Clinical heart failure
- Left ventricular ejection fraction < 35%
- Left ventricular ejection fraction > 45% with dyskinetic or akinetic segment
- Reinfarction
- Post-infarct angina
- Coronary revascularization (CABG or PTCA)
- Systolic blood pressure < 90 mmHg for > 1 hour
- Cardiogenic shock
- Renal dysfunction
- Stroke
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.