China Stroke Secondary Prevention Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Folic Acid and B Vitamins for Secondary Prevention of Stroke : A Double-blinded Randomized Controlled Trial

Conditions
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Stroke, Transient Ischemic Attack

Intervention / Treatment
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* Drug: Folic Acid
* Drug: Vitamin B6
* Drug: Vitamin B12
* Drug: placebo
* Drug: placebo
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin supplements<br> | Drug: Folic Acid<br>* 0.8mg<br>* Other names: folate;Drug: Vitamin B6<br>* 10mg<br>* Other names: Pyridoxine;Drug: Vitamin B12<br>* 500ug<br>* Other names: Cyanocobalamin;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* 0.8 mg<br>Drug: placebo<br>* 10mg<br>Drug: placebo<br>* 500ug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent stroke |  | 3 years | 
| Myocardial infarction |  | 3 years | 
| Death due to other vascular causes |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIA |  | 3 years | 
| Revascularization procedures |  | 3 years | 
| Dementia |  | 3 years | 
| Depression |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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folic acid, B vitamins, secondary prevention, stroke, randomized controlled trial, homocysteine