Supplementation with Folate (and vitamins B6 and B12) and/or Omega 3 Fatty Acids on the prevention of recurrent ischaemic events in patients who have already experienced a coronary or cerebrovascular event
- Conditions
- Cardio and neurovascular diseasesCirculatory System
- Registration Number
- ISRCTN41926726
- Lead Sponsor
- INSERM - Direction of Clinical Research (France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 2400
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
1. Age <45 years or >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.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Combination of myocardial infarction, cerebral vascular ischemic accident or cardiovascular deaths
- Secondary Outcome Measures
Name Time Method 1. Hospitalisation for coronary diseases<br>2. Hospitalisation for cardiac diseases<br>3. Hospitalisation for vascular diseases<br>4. Total mortality<br>5. Cardiovascular mortality<br>6. Myocardial infarctions<br>7. Acute coronary syndrome without necrosis<br>8. Ischemic cerebral vascular accidents<br>9. Arteriopathies<br>10. Venous thrombosis<br>11. Cancers