Stroke, Transient Ischemic Attack
Conditions
Keywords
folic acid, B vitamins, secondary prevention, stroke, randomized controlled trial, homocysteine
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.
Interventions
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrent stroke | 3 years |
| Myocardial infarction | 3 years |
| Death due to other vascular causes | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| TIA | 3 years |
| Depression | 3 years |
| Revascularization procedures | 3 years |
| Dementia | 3 years |
Countries
China
Outcome results
None listed