See also:

CSPPT study, 2015	TRC11319
[NCT00794885]	download pdf: folic acid | plasma homocysteine lowering intervention for cardiovascular prevention

Treatments

Studied treatment	enalapril 10 mg / folic acid 0.8 mg daily
Control treatment	Enalapril maleate 10 mg daily
Concomittant treatment	on top enalapril

Patients

Patients

patients with primary hypertension

Method and design

Randomized effectives	10348 / 10354 (studied vs. control)
Design	Parallel groups
Blinding	double-blind
Geographic area	China
Primary endpoint	symptomatic stroke ( ischemic or hemorrhagic)

Results

Endpoints and data reported in the trial's publication(s)

Endpoint	Events (%)		Relative Risk	95% CI
	Studied treat.	Control treat.
First stroke	282 / 10348 (2,7%)	355 / 10354 (3,4%)	0,79	[0,68;0,93]
Ischemic stroke	223 / 10348 (2,2%)	292 / 10354 (2,8%)	0,76	[0,64;0,91]
Hemorrhagic stroke	58 / 10348 (0,6%)	62 / 10354 (0,6%)	0,94	[0,66;1,34]
Composite of stroke, myocardial infarction, or death due to cardiovascular causes	324 / 10348 (3,1%)	405 / 10354 (3,9%)	0,80	[0,69;0,92]
Myocardial infarctione	25 / 10348 (0,2%)	24 / 10354 (0,2%)	1,04	[0,60;1,82]
Death due to cardiovascular causesf	43 / 10348 (0,4%)	43 / 10354 (0,4%)	1,00	[0,66;1,53]
All-cause death	302 / 10348 (2,9%)	320 / 10354 (3,1%)	0,94	[0,81;1,10]

Endpoints used by the meta-analysis and data retained for this trial

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

All cause death

302 / 10348
320 / 10354
0,94 [0,81;1,10]

Non fatal MI

25 / 10348
24 / 10354
1,04 [0,60;1,82]

cardiovascular events

324 / 10348
405 / 10354
0,80 [0,69;0,92]

Cardiovascular death

43 / 10348
43 / 10354
1,00 [0,66;1,53]

stroke (fatal and non fatal)

282 / 10348
355 / 10354
0,79 [0,68;0,93] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
All cause death	302 / 10348 (2,9%)	320 / 10354 (3,1%)	0,94	[0,81;1,10]	All-cause death
Non fatal MI	25 / 10348 (0,2%)	24 / 10354 (0,2%)	1,04	[0,60;1,82]	Myocardial infarctione
cardiovascular events	324 / 10348 (3,1%)	405 / 10354 (3,9%)	0,80	[0,69;0,92]	Composite of stroke, myocardial infarction, or death due to cardiovascular causes
Cardiovascular death	43 / 10348 (0,4%)	43 / 10354 (0,4%)	1,00	[0,66;1,53]	Death due to cardiovascular causesf
stroke (fatal and non fatal)	282 / 10348 (2,7%)	355 / 10354 (3,4%)	0,79	[0,68;0,93]	First stroke
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction:

Endpoint	studied treat.	control treat.	mean diff

Absolute risk reduction (for a follow-up of )
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
All cause death	2,92%	3,09%	-0,17%
Non fatal MI	2,42‰	2,32‰	0,01%
cardiovascular events	3,13%	3,91%	-0,78%
Cardiovascular death	4,16‰	4,15‰	0,00%
stroke (fatal and non fatal)	2,73%	3,43%	-0,70%

Meta-analysis of all similar trials:

plasma homocysteine lowering intervention in cardiovascular prevention for all type of patients

Reference(s)

TrialResults-center ID	TRC11319
Trials register #	NCT00794885

• Huo Y, Li J, Qin X, Huang Y, Wang X, Gottesman RF, Tang G, Wang B, Chen D, He M, Fu J, Cai Y, Shi X, Zhang Y, Cui Y, Sun N, Li X, Cheng X, Wang J, Yang X, Yang T, Xiao C, Zhao G, Dong Q, Zhu D, Wang X, Ge J, Zhao L, Hu D, Liu L, Hou FF. Efficacy of Folic Acid Therapy in Primary Prevention of Stroke Among Adults With Hypertension in China: The CSPPT Randomized Clinical Trial.. JAMA 2015 Mar 15;: - 10.1001/jama.2015.2274
  Pubmed | Hubmed | Fulltext

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