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financial assistance financial assistance financial assistance financial assistance financial assistance without financial assistance
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin supplements | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folic Acid | Drug | 0.8mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent stroke | 3 years | |
| Myocardial infarction | 3 years | |
| Death due to other vascular causes | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| TIA | 3 years | |
| Revascularization procedures | 3 years | |
| Dementia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gang Zhao, MD | the Department of Neurology , Xijing Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hosptial | Xi’an | Shanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23490255 | Background | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| D025101 | Vitamin B 6 |
| D011736 | Pyridoxine |
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Vitamin B6 |
| Drug |
10mg |
|
|
| Vitamin B12 | Drug | 500ug |
|
|
| placebo | Drug | 0.8 mg |
|
| placebo | Drug | 10mg |
|
| placebo | Drug | 500ug |
|
| 3 years |
| Depression | 3 years |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| D006571 | Heterocyclic Compounds |
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |