Folic Acid and B Vitamins for Secondary Prevention of Stroke : A Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Recurrent stroke
研究概览
简要总结
The CSSPT study is a multi-center, randomized, double blinded, placebo-controlled secondary stroke prevention trial in China to determine whether the addition of folic acid and vitamin supplements will reduce recurrent stroke events and other combined incidence of recurrent vascular events and vascular death.
详细描述
The CSSPT study is a multi-center, randomized, double blinded, placebo-controlled secondary stroke prevention trial in China to determine whether the addition of folic acid and vitamin supplements will reduce recurrent stroke events and other combined incidence of recurrent vascular events and vascular death in patients with recent stroke or transient ischemic attack (TIA). All patients presenting to one of the participating neurologists or general physicians within one months of stroke (ischemic or hemorrhagic) or TIA (eye or brain) are eligible for this trial. Eligible patients will be randomized in a double-blinded fashion to receive multi-vitamins or placebo. The primary outcome event is the composite event "stroke, myocardial infarction, or death from any vascular cause", whichever occurs first. Our target is to recruit a total of 8,000 patients over the two years with a median follow-up of 3 years. Recruitment to the trial began in July 2011 and is planned to continue until December 2013. The investigators aim to complete final follow-up by the end of 2016.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting within one months of ischemic stroke (ischemic or hemorrhagic) or TIA
- •Homocysteine level ≥ 15μmol／L
- •Agree to take study medication;Be geographically accessible for follow-up
- •Provide written informed consent
排除标准
- •Other cause of ischemic stroke (cardioembolism; stroke of other determined etiology, and stroke of undetermined etiology according to TOAST subtypes) or hemorrhagic stroke (intracranial vascular malformations; cerebral amyloid angiopathy; trauma and bleeding disorders etc)
- •Use of vitamin supplements containing folate, B6 or B12
- •Pregnancy or women of child-bearing potential who are at risk of pregnancy
- •Limited life expectancy
研究组 & 干预措施
vitamin supplements
干预措施: Folic Acid (Drug)
vitamin supplements
干预措施: Vitamin B6 (Drug)
vitamin supplements
干预措施: Vitamin B12 (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Recurrent stroke
时间窗: 3 years
Myocardial infarction
时间窗: 3 years
Death due to other vascular causes
时间窗: 3 years
次要结局
- Revascularization procedures(3 years)
- TIA(3 years)
- Dementia(3 years)
- Depression(3 years)