China Stroke Secondary Prevention Trial (CSSPT)

Air Force Military Medical University of People's Liberation Army

Status: Withdrawn

Conditions: Stroke; Transient Ischemic Attack

Treatments: Drug: placebo; Drug: Vitamin B12; Drug: Folic Acid; Drug: Vitamin B6

Study type: Interventional

Funder types: Other

Identifiers

NCT01317849

xijing-003

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

vitamin supplements

Experimental group

Treatment:

Drug: Vitamin B6

Drug: Folic Acid

Drug: Vitamin B12

Placebo

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo