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China Stroke Secondary Prevention Trial (CSSPT)

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ClinicalTrials.gov Identifier: NCT01317849
Recruitment Status : Withdrawn (financial assistance financial assistance financial assistance financial assistance financial assistance without financial assistance)
First Posted : March 17, 2011
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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.

Condition or disease Intervention/treatment Phase
Stroke Transient Ischemic Attack Drug: Folic Acid Drug: Vitamin B6 Drug: Vitamin B12 Drug: placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Folic Acid and B Vitamins for Secondary Prevention of Stroke : A Double-blinded Randomized Controlled Trial
Study Start Date : July 2011
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Drug: placebo
10mg

Drug: placebo
500ug




Primary Outcome Measures :
  1. Recurrent stroke [ Time Frame: 3 years ]
  2. Myocardial infarction [ Time Frame: 3 years ]
  3. Death due to other vascular causes [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. TIA [ Time Frame: 3 years ]
  2. Revascularization procedures [ Time Frame: 3 years ]
  3. Dementia [ Time Frame: 3 years ]
  4. Depression [ Time Frame: 3 years ]


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01317849     History of Changes
Other Study ID Numbers: xijing-003
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014

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

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