Coronary atherosclerotic plaque intervention with Tongxinluo capsule (TXL-CAP): a multicenter, randomized, double-blind and placebo-controlled study

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).

Authors

Institutions

Publication Details

Journal
Signal Transduction and Targeted Therapy
Published
2026-02-24
DOI
https://doi.org/10.1038/s41392-026-02581-z
Primary Topic
Lipid metabolism and disorders
Type
article
Field-Weighted Citation Impact
0.00

Funders

Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Coronary atherosclerotic plaque intervention with Tongxinluo capsule (TXL-CAP): a multicenter, randomized, double-blind and placebo-controlled study

Qiang Xie, Peili Bu, Xi Su, Ranzun Zhao et al.
Signal Transduction and Targeted Therapy
Lipid metabolism and disorders
article

Coronary atherosclerotic plaque intervention with Tongxinluo capsule (TXL-CAP): a multicenter, randomized, double-blind and placebo-controlled study

Qiang Xie, Peili Bu, Xi Su, Ranzun Zhao, Jianhong Tao, Zheng Ji, Huai Yu, YUQUAN HE, Jun Xiao, Yan Qi, Guo J, Yaojun Zhang, Mei Ni, Zengming Xue, C Yao, Y J Zhou, Dayue Darrel DUAN, Lin Wang, for the TXL-CAP Investigators, Bo Yu, Yun Zhang, Bo Zhang, Cheng Zhang, Meng Zhang, Jianqiang Peng, Yun Ti
article en

Abstract

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).

Signal Transduction and Targeted TherapyVol. 11(1)
Jiangsu University (CN), Nanjing University of Chinese Medicine (CN), Union Hospital (HK), Harbin Medical University (CN), Hunan Normal University (CN), Xuzhou Medical College (CN), Zunyi Medical University (CN), Capital Medical University (CN), Dalian Medical University (CN), Jilin University (CN), Peking University (CN), Wuhan University (CN), First Affiliated Hospital of Xiamen University (CN), Tangshan People's Hospital (CN), Xuzhou Cancer Hospital (CN), Liaoning Provincial People's Hospital (CN), Jiangsu Provincial Academy of Traditional Chinese Medicine (CN), Beijing Luhe Hospital Affiliated to Capital Medical University (CN), Beijing Anzhen Hospital (CN), First Hospital of Jilin University (CN), Wuhan Asia Heart Hospital (CN), Peking University First Hospital (CN), Second Affiliated Hospital of Harbin Medical University (CN), Chongqing Emergency Medical Center (CN), First Affiliated Hospital of Dalian Medical University (CN), Xuzhou No.1 People's Hospital (CN), Hunan Provincial People's Hospital (CN), Qilu Hospital of Shandong University (CN), Langfang Normal University (CN), Nanjing Medical University (CN)
Shandong University, Harbin Medical University, Qilu Hospital of Shandong University, Peking University First Hospital, Second Affiliated Hospital of Harbin Medical University, National Natural Science Foundation of China, Chongqing University, Hunan Normal University, Peking University, Dalian Medical University, National Key Research and Development Program of China
Good health and well-being
Openalex Percentile: Top 49%
Lipid metabolism and disorders
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.