Coronary atherosclerotic plaque intervention with Tongxinluo capsule (TXL-CAP): a multicenter, randomized, double-blind and placebo-controlled study
Summary
Clinical evidence of traditional Chinese medicine Tongxinluo capsule therapy on coronary plaque vulnerability is lacking. To investigate whether Tongxinluo may increase coronary plaque stability in patients admitted with acute coronary syndrome based on statin therapy, the TXL-CAP study, a multicenter, randomized, double-blind clinical trial, was conducted. Patients who had a coronary thin-cap lipid-rich plaque detected by optical coherence tomography (OCT) were randomized 1:1 to either To
Content
# Coronary atherosclerotic plaque intervention with Tongxinluo capsule (TXL-CAP): a multicenter, randomized, double-blind and placebo-controlled study
*Published: 2026 Feb 24*
Clinical evidence of traditional Chinese medicine Tongxinluo capsule therapy on
coronary plaque vulnerability is lacking. To investigate whether Tongxinluo may
increase coronary plaque stability in patients admitted with acute coronary
syndrome based on statin therapy, the TXL-CAP study, a multicenter, randomized,
double-blind clinical trial, was conducted. Patients who had a coronary thin-cap
lipid-rich plaque detected by optical coherence tomography (OCT) were randomized
1:1 to either Tongxinluo or placebo treatment for 12 months on the basis of
guideline-directed treatment. The primary endpoint was the difference in the
minimum fibrous cap thickness of the OCT-assessed lesions between Tongxinluo and
placebo groups in patients at the end of 12 months. A total of 220 patients were
finally recruited and randomized. For the primary endpoint, the minimum fibrous
cap thickness did not differ between the two groups at baseline but increased in
the Tongxinluo group relative to the placebo group at the 12-month follow-up
(115.0 μm vs. 80.0 μm, P < 0.001). The increase in the minimum fibrous cap
thickness (61.2 μm vs. 33.7 μm, P = 0.002) and the decrease in the maximum lipid
arc (-38.4° vs. -8.1°, P = 0.007) were greater in the Tongxinluo group than in
the placebo group. The Tongxinluo group showed improvement in both the Seattle
Angina Questionnaire score and the Canadian Cardiovascular Society grading of
angina pectoris compared to the placebo group. In conclusion, on the basis of
statins, Tongxinluo increased fibrous cap thickness, reduced the lipid arc of
coronary thin-cap lipid-rich plaques, and improved angina symptoms without
lowering cardiovascular events at the 12-month follow-up in patients with acute
coronary syndrome. ( http://www.chictr.org.cn , ID: ChiCTR1900025842).
DOI: 10.1038/s41392-026-02581-z