These authors contributed equally to this work.
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
Version of Record online: 12 MAR 2013
© 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization
International Journal of Stroke
Volume 10, Issue 2, pages 264–268, February 2015
How to Cite
Liu, X., Shi, M., Xia, F., Han, J., Liu, Z., Wang, B., Yang, F., Li, L., Wu, S., Wang, L., Liu, N., Lv, Y. and Zhao, G. (2015), 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. International Journal of Stroke, 10: 264–268. doi: 10.1111/ijs.12017
Conflict of interest: None declared.
Funding: This trial is funded by the Shaanxi Province Association of Neurology.
Trial registration number: Clinical Trials.gov Identifier: NCT01317849.
- Issue online: 19 JAN 2015
- Version of Record online: 12 MAR 2013
- Manuscript Accepted: 2 AUG 2012
- Manuscript Received: 22 MAR 2012
- Shaanxi Province Association of Neurology
- randomized clinical trial;
- stroke prevention
Epidemiological studies suggest that elevated homocysteine is linked to stroke and heart disease. However, the results of lowering homocysteine levels in reducing the risk of stroke recurrence are controversial.
The study aims to evaluate whether homocysteine-lowering therapy with folic acid and vitamins B6 and B12 reduces recurrent stroke events and other combined incidence of recurrent vascular events and vascular death in ischemic stroke patients of low folate regions.
This is a multicenter, randomized, double-blinded, placebo-controlled trial. Patients (n = 8000, α = 0·05, β = 0·10) within one-month of ischemic stroke (large-artery atherosclerosis or small-vessel occlusion) or hypertensive intracerebral haemorrhage with plasma homocysteine level ≥15 μmol/l will be enrolled. Eligible patients will be randomized by a web-based, random allocation system to receive multivitamins (folic acid 0·8 mg, vitamin B6 10 mg, and vitamin B12 500 μg) or matching placebo daily with a median follow-up of three-years.
Patients will be evaluated at six monthly intervals. The primary outcome event is the composite event ‘stroke, myocardial infarction, or death from any vascular cause’, whichever occurs first. Secondary outcome measures include nonvascular death, transient ischemic attack, depression, dementia, unstable angina, revascularization procedures of the coronary, and cerebral and peripheral circulations.
This is the first multicenter randomized trial of secondary prevention for ischemic stroke in a Chinese population with a higher homocysteine level but without folate food fortification.