Randomised, double-blind, placebo-controlled secondary prevention clinical trial with cardiovascular disease (CVD) survivors (N=2,501; aged 45-80 years). It employed a 2x2 factorial design (4 possible combinations) as well as B vitamins and n-3 PUFA delivered at nutritional doses. Specifically, individuals who had experienced a myocardial infarction (MI), an acute coronary attack without necrosis or an ischemic stroke in the 1 to 12 months prior to their enrolment in the study were randomly allocated to one of the 4 possible combinations:
- Double placebo
- Placebo and B vitamins (5-methyl-THF, 560 µg; vitamin B6, 3 mg; vitamin B12, 20 µg)
- Placebo and long chain n-3 PUFA (600 mg EPA and DHA in a 2:1 ratio)
- Both B vitamins and n-3 PUFA
The follow-up lasted 5 years during which time a Biobank and a DNA database (DNAthèque) were established. The principle outcomes included the development of a recurrent MI, stroke or death due to a cardiovascular problem. Secondary outcomes included: mortality (any cause), hospital admission due to CVD or coronary artery disease, or hospitalisation due to vascular disease. Follow-up questionnaires were sent to the participants every 6 months in order to collect information on newly developed health events (disease, hospital admissions...) and on the evolution of risk and protective factors (eg, diet, smoking, physical activity...). The intervention terminated in July 2009.