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

INSERM - Direction of Clinical Research (France)0 个研究点目标入组 2,400 人开始时间: 2005年12月5日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•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.)

发起方

INSERM - Direction of Clinical Research (France)