China Stroke Secondary Prevention Trial "CSSPT"

Withdrawn

Phase N/A Results N/A

Trial 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.

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.

Trial Stopped: financial assistance financial assistance financial assistance financial assistance financial assistance without financial assistance

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: 500ug
    ARM 1: Kind: Experimental
    Label: Placebo
  • Folic Acid (Folate, Folacin,)Drug
    Intervention Desc: 0.8mg
    ARM 1: Kind: Experimental
    Label: vitamin supplements
  • Vitamin B6 Drug
    Intervention Desc: 10mg
    ARM 1: Kind: Experimental
    Label: vitamin supplements
  • Vitamin B12 Drug
    Intervention Desc: 500ug
    ARM 1: Kind: Experimental
    Label: vitamin supplements

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Non-fatal stroke 36 months Yes
Secondary Death due to vascular causes 36 months Yes
Secondary Non-fatal myocardial infarction 36 months Yes
Primary Recurrent stroke trial end Yes
Primary Myocardial infarction trial end Yes
Primary Death due to other vascular causes trial end Yes
Secondary TIA trial end Yes
Secondary Revascularization procedures trial end Yes
Secondary Dementia trial end Yes
Secondary Depression trial end Yes

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