25771069
OBJECTIVE	Uncertainty remains about the efficacy of folic acid therapy for the primary prevention of stroke because of limited and inconsistent data .
OBJECTIVE	To test the primary hypothesis that therapy with enalapril and folic acid is more effective in reducing first stroke than enalapril alone among Chinese adults with hypertension .
METHODS	The China Stroke Primary Prevention Trial , a randomized , double-blind clinical trial conducted from May 19 , 2008 , to August 24 , 2013 , in 32 communities in Jiangsu and Anhui provinces in China .
METHODS	A total of 20,702 adults with hypertension without history of stroke or myocardial infarction ( MI ) participated in the study .
METHODS	Eligible participants , stratified by MTHFR C677T genotypes ( CC , CT , and TT ) , were randomly assigned to receive double-blind daily treatment with a single-pill combination containing enalapril , 10 mg , and folic acid , 0.8 mg ( n = 10,348 ) or a tablet containing enalapril , 10 mg , alone ( n = 10,354 ) .
METHODS	The primary outcome was first stroke .
METHODS	Secondary outcomes included first ischemic stroke ; first hemorrhagic stroke ; MI ; a composite of cardiovascular events consisting of cardiovascular death , MI , and stroke ; and all-cause death .
RESULTS	During a median treatment duration of 4.5 years , compared with the enalapril alone group , the enalapril-folic acid group had a significant risk reduction in first stroke ( 2.7 % of participants in the enalapril-folic acid group vs 3.4 % in the enalapril alone group ; hazard ratio [ HR ] , 0.79 ; 95 % CI , 0.68-0 .93 ) , first ischemic stroke ( 2.2 % with enalapril-folic acid vs 2.8 % with enalapril alone ; HR , 0.76 ; 95 % CI , 0.64-0 .91 ) , and composite cardiovascular events consisting of cardiovascular death , MI , and stroke ( 3.1 % with enalapril-folic acid vs 3.9 % with enalapril alone ; HR , 0.80 ; 95 % CI , 0.69-0 .92 ) .
RESULTS	The risks of hemorrhagic stroke ( HR , 0.93 ; 95 % CI , 0.65-1 .34 ) , MI ( HR , 1.04 ; 95 % CI , 0.60-1 .82 ) , and all-cause deaths ( HR , 0.94 ; 95 % CI , 0.81-1 .10 ) did not differ significantly between the 2 treatment groups .
RESULTS	There were no significant differences between the 2 treatment groups in the frequencies of adverse events .
CONCLUSIONS	Among adults with hypertension in China without a history of stroke or MI , the combined use of enalapril and folic acid , compared with enalapril alone , significantly reduced the risk of first stroke .
CONCLUSIONS	These findings are consistent with benefits from folate use among adults with hypertension and low baseline folate levels .
BACKGROUND	clinicaltrials.gov Identifier : NCT00794885 .

