China Stroke Secondary Prevention Trial

Not Applicable

Withdrawn

• Conditions: Stroke; Transient Ischemic Attack
• Interventions: Drug: placebo; Drug: Folic Acid; Drug: Vitamin B6; Drug: Vitamin B12

• Registration Number: NCT01317849
• Lead Sponsor: Xijing Hospital

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.

Study Timeline

• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-16
• Study First Posted: 2011-03-17
• Study Start: 2011-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-18
• Last Update Posted: 2014-08-20
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamin supplements	Vitamin B6	-
Placebo	placebo	-
vitamin supplements	Folic Acid	-
vitamin supplements	Vitamin B12	-

Primary Outcome Measures

Name	Time	Method
Recurrent stroke	3 years
Myocardial infarction	3 years
Death due to other vascular causes	3 years

Secondary Outcome Measures

Name	Time	Method
Revascularization procedures	3 years
TIA	3 years
Dementia	3 years
Depression	3 years

Trial Locations

Locations (1)

Xijing Hosptial; 🇨🇳 Xi'an, Shanxi, China