Cardio and neurovascular diseases Circulatory System
Conditions
Interventions
5-methyl-THF (560 µg), vitamin B6 (3 mg) and B12 (20 µg) and/or omega-3 supplements (600 mg with an eicosapentaenoic acid [EPA]:docosahexaenoic acid [DHA] ratio of 2:1) versus placebo
Sponsors
INSERM - Direction of Clinical Research (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants should have experienced a coronary or cerebral event during 1 to 12 months before baseline. A coronary or cerebral event is defined as: a. Myocardial infarction (validated and documented by a combination of clinical, enzymatic, or electrocardiogram [ECG] parameters) b. Acute coronary syndrome without necrosis (validated and documented by a combination of clinical, enzymatic or ECG parameters) c. A cerebral vascular ischemic accident (defined by criteria validated in epidemiological studies) 2. The participants should be 45-80 years at baseline
Exclusion criteria
Exclusion criteria: 1. Age 80 years 2. Cardiovascular pathology not well defined 3. Patients that are incapable of understanding the study protocol 4. Patients with a pathology that might interfere with homocysteine or omega-3 fatty acid metabolism, in particular those that use methotrexate for the treatment of a cancer or rheumatoid arthritis and chronic renal failure (plasma level of creatinine >200 µmol/l or creatinine clearance <40 ml/min) 5. Patients with a non-cardiovascular pathology with a suspected survival time less than the 5 years period of the study (solid cancer, evolved dementia, leukemia etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combination of myocardial infarction, cerebral vascular ischemic accident or cardiovascular deaths | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hospitalisation for coronary diseases 2. Hospitalisation for cardiac diseases 3. Hospitalisation for vascular diseases 4. Total mortality 5. Cardiovascular mortality 6. Myocardial infarctions 7. Acute coronary syndrome without necrosis 8. Ischemic cerebral vascular accidents 9. Arteriopathies 10. Venous thrombosis 11. Cancers | — |
Countries
France
Outcome results
None listed