Clinical trial NCT01317849: China Stroke Secondary Prevention Trial
Official title: Folic Acid and B Vitamins for Secondary Prevention of Stroke : A Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Transient Ischemic Attack
Keywords: folic acid
B vitamins
secondary prevention
stroke
randomized controlled trial
homocysteine
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrent stroke
timeFrame: 3 years
measure: Myocardial infarction
timeFrame: 3 years
measure: Death due to other vascular causes
timeFrame: 3 years
Secondary outcomes:
measure: TIA
timeFrame: 3 years
measure: Revascularization procedures
timeFrame: 3 years
measure: Dementia
timeFrame: 3 years
measure: Depression
timeFrame: 3 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hosptial
state: Shanxi
Study officials:
affiliation: the Department of Neurology , Xijing Hospital
name: Gang Zhao, MD
role: STUDY_DIRECTOR
References:
citation: Liu X, Shi M, Xia F, Han J, Liu Z, Wang B, Yang F, Li L, Wu S, Wang L, Liu N, Lv Y, Zhao G. The China Stroke Secondary Prevention Trial (CSSPT) protocol: a double-blinded, randomized, controlled trial of combined folic acid and B vitamins for secondary prevention of stroke. Int J Stroke. 2015 Feb;10(2):264-8. doi: 10.1111/ijs.12017. Epub 2013 Mar 12.