China Stroke Secondary Prevention Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2016-06-30

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.

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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.

Conditions

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Stroke Transient Ischemic Attack

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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vitamin supplements

Group Type EXPERIMENTAL

Folic Acid

Intervention Type DRUG

0.8mg

Vitamin B6

Intervention Type DRUG

10mg

Vitamin B12

Intervention Type DRUG

500ug

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

0.8 mg

placebo

Intervention Type DRUG

10mg

placebo

Intervention Type DRUG

500ug

Interventions

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Folic Acid

0.8mg

Intervention Type DRUG

Vitamin B6

10mg

Intervention Type DRUG

Vitamin B12

500ug

Intervention Type DRUG

placebo

0.8 mg

Intervention Type DRUG

placebo

10mg

Intervention Type DRUG

placebo

500ug

Intervention Type DRUG

Other Intervention Names

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folate Pyridoxine Cyanocobalamin

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No