China Stroke Secondary Prevention Trial (CSSPT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01317849
First received: March 15, 2011
Last updated: January 31, 2013
Last verified: December 2011

March 15, 2011
January 31, 2013
July 2011
June 2016   (final data collection date for primary outcome measure)
  • Recurrent stroke [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Death due to other vascular causes [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Non-fatal stroke [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01317849 on ClinicalTrials.gov Archive Site
  • TIA [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Revascularization procedures [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Dementia [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Depression [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Death due to vascular causes [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Non-fatal myocardial infarction [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
China Stroke Secondary Prevention Trial
Folic Acid and B Vitamins for Secondary Prevention of Stroke : A Double-blinded Randomized Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Stroke
  • Transient Ischemic Attack
  • Drug: Folic Acid
    0.8mg
    Other Name: folate
  • Drug: Vitamin B6
    10mg
    Other Name: Pyridoxine
  • Drug: Vitamin B12
    500ug
    Other Name: Cyanocobalamin
  • Drug: placebo
    0.8 mg
    Other Name: placebo
  • Drug: placebo
    10mg
    Other Name: placebo
  • Drug: placebo
    500ug
    Other Name: placebo
  • Experimental: vitamin supplements
    Interventions:
    • Drug: Folic Acid
    • Drug: Vitamin B6
    • Drug: Vitamin B12
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: placebo
    • Drug: placebo
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
8000
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01317849
xijing-003
Yes
Xijing Hospital
Xijing Hospital
Not Provided
Study Director: Gang Zhao, MD the Department of Neurology , Xijing Hospital
Xijing Hospital
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP