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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
History of Changes
  Purpose

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.


Condition Intervention
Stroke
Transient Ischemic Attack
 Drug: Folic Acid
Drug: Vitamin B6
Drug: Vitamin B12
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Folic Acid and B Vitamins for Secondary Prevention of Stroke : A Double-blinded Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 8000
Study Start Date: July 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vitamin supplements Drug: Folic Acid
0.8mg
Other Name: folate
Drug: Vitamin B6
10mg
Other Name: Pyridoxine
Drug: Vitamin B12
500ug
Other Name: Cyanocobalamin
Placebo Comparator: Placebo Drug: placebo
0.8 mg
Other Name: placebo
Drug: placebo
10mg
Other Name: placebo
Drug: placebo
500ug
Other Name: placebo

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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317849

Locations
China, Shanxi
Xijing Hosptial
Xi'an, Shanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Director: Gang Zhao, MD the Department of Neurology , Xijing Hospital
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01317849     History of Changes
Other Study ID Numbers: xijing-003
Study First Received: March 15, 2011
Last Updated: January 31, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
folic acid
B vitamins
secondary prevention
 stroke
randomized controlled trial
homocysteine

Additional relevant MeSH terms:
Ischemic Attack, Transient
Stroke
Cerebral Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Folic Acid
Vitamin B Complex
 Hydroxocobalamin
Vitamin B 12
Pyridoxine
Vitamin B 6
Pyridoxal
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013