Naoxintong Capsule for Secondary Prevention of Ischemic Stroke: A Multicenter, Randomized, and Placebo-Controlled Trial.
Chin J Integr Med
; 28(12): 1063-1071, 2022 Dec.
Article
in En
| MEDLINE
| ID: mdl-36251140
ABSTRACT
OBJECTIVE:
To examine whether the combination of Naoxintong Capsule with standard care could further reduce the recurrence of ischemic stroke without increasing the risk of severe bleeding.METHODS:
A total of 23 Chinese medical centers participated in this trial. Adult patients with a history of ischemic stroke were randomly assigned in a 11 ratio using a block design to receive either Naoxintong Capsule (1.2 g orally, twice a day) or placebo in addition to standard care. The primary endpoint was recurrence of ischemic stroke within 2 years. Secondary outcomes included myocardial infarction, death due to recurrent ischemic stroke, and all-cause mortality. The safety of drugs was monitored. Results were analyzed using the intention-to-treat principle.RESULTS:
A total of 2,200 patients were enrolled from March 2015 to March 2016, of whom 143 and 158 in the Naoxintong and placebo groups were lost to follow-up, respectively. Compared with the placebo group, the recurrence rate of ischemic stroke within 2 years was significantly lower in the Naoxintong group [6.5% vs. 9.5%, hazard ratio (HR) 0.665, 95% confidence interval (CI) 0.492-0.899, P=0.008]. The two groups showed no significant differences in the secondary outcomes and safety, including rates of severe hemorrhage, cerebral hemorrhage and subarachnoid hemorrhage (P>0.05).CONCLUSION:
The combination of Naoxintong Capsule with standard care reduced the 2-year stroke recurrence rate in patients with ischemic stroke without increasing the risk of severe hemorrhage in high-risk patients. (Trial registration No. NCT02334969).Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Stroke
/
Ischemic Stroke
Type of study:
Clinical_trials
Limits:
Adult
/
Humans
Language:
En
Journal:
Chin J Integr Med
Journal subject:
TERAPIAS COMPLEMENTARES
Year:
2022
Document type:
Article
Affiliation country:
China