GISSI-P, 1999 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of Omacor versus control in people with recent myocardial infarction

        Z

Circulation 2002 Apr 23;105:1897-903  



Studied treatment Omacor gelatine capsules, 1/d (0.9g/d EPA + DHA daily)
Control treatment no treatment



Patients people with recent myocardial infarction
Group sizes5665 / 5668
global risk of bias Medium or high
diabetes (%)
BMI
cardiovascular history (%)
diabetes (%)
Total cholesterol (mmol/L)
Blood pressure SBP/DBP (mmHg)
Statin at baseline (%)
Level of risk for CVD



Blindness open Inclusion period
Follow-up duration median 40 months Centers
Lost to FU ?/5665, ?/5658 geographical localisation Italy
Primary endpoint death, stroke, MI Design Parallel groups



EndpointX1N1X0N0TE95% CI sudden cardiac death - 5665 - 5668 no data coronary death - 5665 - 5668 no data MI - 5665 - 5668 no data cardiovascular death - 5665 - 5668 no data coronary events - 5665 - 5668 no data cardiovascular events 556 5665 621 5658 0,89[0,79; 1,01] cancer (new or death) 142 5665 134 5658 1,06[0,83; 1,34] all cause death 477 5665 554 5658 0,86[0,76; 0,98] stroke (fatal & non fatal) 92 5665 77 5658 1,19[0,88; 1,62]0,22,01,0

Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico. Lancet 1999 Aug 7;354:447-55     [PMID: 10465168]   link to pdf   add to Mendeley  

Marchioli R, Barzi F, Bomba E, Chieffo C, Di Gregorio D, Di Mascio R, Franzosi MG, Geraci E, Levantesi G, Maggioni AP, Mantini L, Marfisi RM, Mastrogiuseppe G, Mininni N, Nicolosi GL, Santini M, Schweiger C, Tavazzi L, Tognoni G, Tucci C, Valagussa F Early protection against sudden death by n-3 polyunsaturated fatty acids after myocardial infarction: time-course analysis of the results of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI)-Prevenzione. Circulation 2002 Apr 23;105:1897-903     [PMID: 11997274]   link to pdf   add to Mendeley  



Registering number (see trial on clinicaltrials.gov)
Code Name