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Protocol for a randomized controlled trial of Xueshuantong injection on
myocardial injury and residual cardiovascular risk in patients with unstable
angina
#MMPMID41195123
Wang Y
; Liu G
; Lu Z
; Xi J
; Feng W
; Ma Y
; Lyu J
; Xie Y
Front Cardiovasc Med
2025[]; 12
(?): 1602666
PMID41195123
show ga
BACKGROUND: Unstable angina (UA) is a critical subtype of acute coronary syndrome
(ACS). Myocardial injury is a key determinant of disease progression and
long-term prognosis, yet it often persists despite standard therapy. In addition,
residual inflammation remains an important risk factor for adverse outcomes.
Xueshuantong Injection Lyophilized (XST), derived from Panax notoginseng saponins
(PNS), has shown potential to reduce myocardial injury and modulate inflammatory
responses in cardiovascular disease, but its efficacy in UA has not been fully
evaluated. METHODS: This is a randomized, parallel control, double-blind,
small-sample exploratory clinical trail. Participants will be recruited from
Xiyuan Hospital, China Academy of Chinese Medical Sciences (Beijing, China).
Eligible patients with UA will be randomized into two groups. The intervention
group will receive XST 500?mg intravenously once daily for 7 days, and the
control group will receive XST 25?mg intravenously once daily for 7 days. The
primary outcome is CK-MB at Day 7. Secondary outcomes are cTnT, NT-proBNP,
inflammatory/endothelial biomarkers (hs-CRP, IL-6, MMP-9, VEGF, HMGB1), and
angina-related parameters (attack frequency, symptom severity). ETHICS AND
REGISTRATION: The trial has been approved by the Ethics Committee of Xiyuan
Hospital and registered in the ITMCTR on March 21, 2025,
http://itmctr.ccebtcm.org.cn (No. ITMCTR2025000552). CONCLUSION: This exploratory
study will evaluate the efficacy and safety of XST in reducing myocardial injury
and residual risk in UA patients, providing evidence for future large-scale
confirmatory trials.