NCT01317849

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 20, 2014

Status Verified

August 1, 2014

Enrollment Period

4.9 years

First QC Date

March 15, 2011

Last Update Submit

August 18, 2014

Conditions

StrokeTransient Ischemic Attack

Keywords

folic acidB vitaminssecondary preventionstrokerandomized controlled trialhomocysteine

Outcome Measures

Primary Outcomes (3)

  • Recurrent stroke

    3 years

  • Myocardial infarction

    3 years

  • Death due to other vascular causes

    3 years

Secondary Outcomes (4)

  • TIA

    3 years

  • Revascularization procedures

    3 years

  • Dementia

    3 years

  • Depression

    3 years

Study Arms (2)

vitamin supplements

EXPERIMENTAL
Drug: Folic AcidDrug: Vitamin B6Drug: Vitamin B12

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

Folic AcidDRUG

0.8mg

Also known as: folate
vitamin supplements
Vitamin B6DRUG

10mg

Also known as: Pyridoxine
vitamin supplements
Vitamin B12DRUG

500ug

Also known as: Cyanocobalamin
vitamin supplements
placeboDRUG

0.8 mg

Placebo

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hosptial

Xi’an, Shanxi, 710032, China

Location

Related 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.

    PMID: 23490255BACKGROUND

MeSH Terms

Conditions

StrokeIschemic Attack, Transient

Interventions

Folic AcidVitamin B 6PyridoxineVitamin B 12

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPicolinesPyridinesHeterocyclic Compounds, 1-RingCorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 4 or More RingsMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Gang Zhao, MD

    the Department of Neurology , Xijing Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2011

First Posted

March 17, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 20, 2014

Record last verified: 2014-08

Locations

CN(1)