China Stroke Secondary Prevention Trial

Stroke Clinical Trial

— CSSPT  

Official title:

Folic Acid and B Vitamins for Secondary Prevention of Stroke : A Double-blinded Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01317849
• Other study ID #: xijing-003
• Status: Withdrawn
• Phase: N/A
• First received: March 15, 2011
• Last updated: August 18, 2014
• Start date: July 2011
• Est. completion date: June 2016

Study information

• Verified date: August 2014
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

Drug:
• Folic Acid
0.8mg
• Vitamin B6
10mg
• Vitamin B12
500ug
• placebo
0.8 mg
• placebo
10mg
• placebo
500ug

Locations

Country	Name	City	State
China	Xijing Hosptial	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent stroke		3 years	Yes
Primary	Myocardial infarction		3 years	Yes
Primary	Death due to other vascular causes		3 years	Yes
Secondary	TIA		3 years	Yes
Secondary	Revascularization procedures		3 years	Yes
Secondary	Dementia		3 years	Yes
Secondary	Depression		3 years	Yes