StrokeCSSPTNCT01317849
China Stroke Secondary Prevention Trial
A study testing Folic Acid, Vitamin B6 and Vitamin B12 in people with Stroke and Transient Ischemic Attack, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Stroke, Transient Ischemic Attack
- What is being tested?
- Folic Acid, Vitamin B6 and Vitamin B12
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Transient Ischemic Attack
- Being tested
- Folic Acid, Vitamin B6, Vitamin B12, placebo
- Keywords
- folic acid, B vitamins, secondary prevention, stroke, randomized controlled trial, homocysteine
- Medical subject headings
- Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic AcidDrug
Also called folate
0.8mg
Vitamin B6Drug
Also called Pyridoxine
10mg
Vitamin B12Drug
Also called Cyanocobalamin
500ug
placeboDrug
0.8 mg
placeboDrug
10mg
placeboDrug
500ug
| Study group | Role | What they receive |
|---|---|---|
| vitamin supplements | Experimental | Not described Receives: Drug: Folic Acid; Drug: Vitamin B6; Drug: Vitamin B12 |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent stroke
Measured: 3 years
Myocardial infarction
Measured: 3 years
Death due to other vascular causes
Measured: 3 years
Secondary outcomes (4)
TIA
Measured: 3 years
Revascularization procedures
Measured: 3 years
Dementia
Measured: 3 years
Depression
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Why it stopped: financial assistance financial assistance financial assistance financial assistance financial assistance without financial assistance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Zhao, MD, Study director, the Department of Neurology , Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317849
- Sponsor's protocol ID
- xijing-003
- Acronym
- CSSPT
- Status last verified
- Aug 2014
- First submitted
- 15 Mar 2011
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23490255
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Folic Acid and B Vitamins for Secondary Prevention of Stroke : A Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01317849
- Acronym / sponsor ID
- CSSPT / xijing-003
- Conditions
- Stroke, Transient Ischemic Attack
- Keywords
- folic acid, B vitamins, secondary prevention, stroke, randomized controlled trial, homocysteine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: financial assistance financial assistance financial assistance financial assistance financial assistance without financial assistance
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin supplements | Experimental | Drug: Folic Acid, Drug: Vitamin B6, Drug: Vitamin B12 |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic AcidAlso: folate0.8mg | Drug | vitamin supplements |
| Vitamin B6Also: Pyridoxine10mg | Drug | vitamin supplements |
| Vitamin B12Also: Cyanocobalamin500ug | Drug | vitamin supplements |
| placebo0.8 mg | Drug | Placebo |
| placebo10mg | Drug | Placebo |
| placebo500ug | Drug | Placebo |
Primary outcome
Recurrent stroke
Time frame: 3 years
Myocardial infarction
Time frame: 3 years
Death due to other vascular causes
Time frame: 3 years
4 secondary outcomes
TIA
Time frame: 3 years
Revascularization procedures
Time frame: 3 years
Dementia
Time frame: 3 years
Depression
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
- Background: PubMed 23490255Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Zhao, MD study director
the Department of Neurology , Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Folic Acid, Vitamin B6 and Vitamin B12 in people with Stroke and Transient Ischemic Attack, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent stroke (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01317849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.