Cohort of subjects with a history of cardio-ischemic disease. This is a 2×2 factorial, double-blind, secondary prevention therapeutic trial in which 2,501 patients (aged 45 to 80) with a coronary or cerebrovascular event 1 to 12 months prior to inclusion (myocardial infarction ; acute coronary syndrome without authenticated necrosis; or ischemic stroke) were randomized into four arms to receive or not, in combination or not, nutritional doses of B vitamins or w-3 polyunsaturated fatty acids (PUFAs):
- double placebo
- placebo and B vitamins: 5-methyl-THF (560 µg), vitamin B6 (3 mg), vitamin B12 (20 µg)
- placebo and long-chain w-3 PUFAs (600 mg EPA and DHA in a 2:1 EPA/DHA ratio)
- B vitamins and w-3 PUFAs
Monitoring lasted 5 years, during which time a biobank and DNA library were set up. The primary endpoint was a combination of myocardial infarction, stroke and cardiovascular death. Secondary endpoints included total mortality, hospitalization for coronary or cardiac pathology, and hospitalization for vascular pathology. A follow-up questionnaire was sent to participants every 6 months. It provided information on health events (illnesses, hospitalizations, etc.) and on changes in certain risk and lifestyle factors (diet, smoking, physical activity, etc.). The intervention ended in 2010.
