China Stroke Secondary Prevention Trial
关键词
抽象
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.
日期
| 最后验证: | 07/31/2014 |
| 首次提交: | 03/14/2011 |
| 提交的预估入学人数: | 03/15/2011 |
| 首次发布: | 03/16/2011 |
| 上次提交的更新: | 08/17/2014 |
| 最近更新发布: | 08/19/2014 |
| 实际学习开始日期: | 06/30/2011 |
| 预计主要完成日期: | 05/31/2016 |
| 预计完成日期: | 05/31/2016 |
状况或疾病
干预/治疗
Drug: vitamin supplements
Drug: vitamin supplements
Drug: vitamin supplements
Drug: Placebo
Drug: Placebo
Drug: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: vitamin supplements | Drug: vitamin supplements 0.8mg |
| Placebo Comparator: Placebo | Drug: Placebo 0.8 mg |
资格标准
| 有资格学习的年龄 | 35 Years 至 35 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
结果
主要结果指标
1. Recurrent stroke [3 years]
2. Myocardial infarction [3 years]
3. Death due to other vascular causes [3 years]
次要成果指标
1. TIA [3 years]
2. Revascularization procedures [3 years]
3. Dementia [3 years]
4. Depression [3 years]
