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

Q: What are the key findings of this study?

Tongxinluo capsule increased minimum fibrous cap thickness by 35 μm more than placebo (115.0 μm vs. 80.0 μm, P < 0.001) at 12 months in patients with ACS and thin-cap lipid-rich plaques on statins.

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Patients aged 18-80 years with acute coronary syndrome and coronary thin-cap lipid-rich plaques defined by OCT with fibrous cap thickness 90°, on guideline-directed statin therapy (n=220). Intervention: Tongxinluo capsule (TXL) vs. Placebo capsule with identical appearance. Primary outcome: Minimum fibrous cap thickness (FCT) of OCT-assessed coronary lesions at 12 months (P < 0.001, p=<0.001).

Q: What question did this study set out to answer?

To evaluate whether adding Tongxinluo capsule to standard statin therapy increases coronary plaque stability in patients admitted with acute coronary syndrome.

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

doi:10.1038/s41392-026-02581-z

Key result

Tongxinluo increases minimum fibrous cap thickness by ~35 μm vs placebo in statin-treated ACS patients.

P < 0.001
P<0.001
n=220

Why the study?

Clinical evidence evaluating the effect of traditional Chinese medicine Tongxinluo capsule on coronary plaque vulnerability in patients admitted with acute coronary syndrome on statin therapy was lacking.

Does Tongxinluo capsule improve coronary plaque stability (fibrous cap thickness) in patients with acute coronary syndrome on statin therapy?

Key Points

To evaluate whether adding Tongxinluo capsule to standard statin therapy increases coronary plaque stability in patients admitted with acute coronary syndrome.
Conducted a multicenter, randomized, double-blind, placebo-controlled trial across 17 centers in China enrolling 220 patients with acute coronary syndrome who had an optical coherence tomography (OCT)-detected thin-cap lipid-rich plaque (ChiCTR1900025842).
Randomized patients 1:1 to receive Tongxinluo capsule (n = 110) or matching placebo (n = 110) for 12 months on the basis of guideline-directed medical therapy, with statins administered to 92.7% of the Tongxinluo group and 93.6% of the placebo group.
At the 12-month follow-up, the minimum fibrous cap thickness was significantly greater in the Tongxinluo group than in the placebo group (115.0 μm vs. 80.0 μm, P < 0.001), showing a larger increase from baseline (61.2 μm vs. 33.7 μm, P = 0.002).
Tongxinluo treatment produced a greater reduction in the maximum lipid arc (−38.4° vs. −8.1°, P = 0.007) and a higher proportion of patients with Canadian Cardiovascular Society Grade I angina (92.3% vs. 63.2%, P < 0.001), without lowering cardiovascular events at 12 months.

Study Design

Type

RCT (n=220)

Blinding

Double-blind

Randomization

Central randomization system with 1:1 allocation

Multicenter

Yes

Structured PICO

Does Tongxinluo capsule improve coronary plaque stability (fibrous cap thickness) in patients with acute coronary syndrome on statin therapy?

P

Population

220 patients admitted with acute coronary syndrome (ACS) who had a coronary thin-cap lipid-rich plaque detected by optical coherence tomography (OCT), mean age 58.6 years, 70.5% male, from 17 centers in China.

I

Intervention

Tongxinluo (TXL) capsule for 12 months added to guideline-directed treatment (including statin therapy).

C

Comparator

Matching placebo for 12 months added to guideline-directed treatment (including statin therapy).

O

Outcome

Difference in the minimum fibrous cap thickness of the OCT-assessed lesions between Tongxinluo and placebo groups at the end of 12 months.surrogate

Main Result

Effect estimate: P < 0.001

Absolute Event Rate: 115% vs 80%

p-value: p=<0.001

In patients with ACS on statin therapy, the addition of Tongxinluo capsule significantly increased fibrous cap thickness and reduced the lipid arc of vulnerable plaques, while also improving angina symptoms.

Limitations

Loss to follow-up due to COVID-19 pandemic with potential selection bias though sensitivity analyses were robust
Study was underpowered to detect significant differences in cardiovascular events
Only Chinese patients enrolled which may limit generalizability to other ethnic groups
Loss to follow-up due to the COVID-19 pandemic, with potential selection bias
Underpowered to detect differences in secondary endpoints like composite cardiovascular events
Only Chinese patients were enrolled, limiting generalizability to other ethnic groups

Discussion

No takes yet. Share an insight, caveat, or question.

Implication

Supports adjunctive Tongxinluo with statins for plaque stabilization in ACS; extends RCT evidence for TCM in vulnerable coronary disease.

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).

Figures from the paper

Published by Signal Transduction and Targeted Therapy · CC BY-NC-ND

Cite This Study

Ni et al. (2026) conducted an RCT in Patients aged 18-80 years with acute coronary syndrome and coronary thin-cap lipid-rich plaques defined by OCT with fibrous cap thickness <100 μm and lipid arc >90°, on guideline-directed statin therapy (n=220). Tongxinluo capsule (TXL) vs. Placebo capsule with identical appearance was evaluated on Minimum fibrous cap thickness (FCT) of OCT-assessed coronary lesions at 12 months (P < 0.001, p=<0.001). Tongxinluo capsule increased minimum fibrous cap thickness by 35 μm more than placebo (115.0 μm vs. 80.0 μm, P < 0.001) at 12 months in patients with ACS and thin-cap lipid-rich plaques on statins.

synapsesocial.com/papers/699fe32295ddcd3a253e6bda https://doi.org/10.1038/s41392-026-02581-z

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

Key Points

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Abstract

Figures from the paper

Cite This Study

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

Key Points

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Abstract

Figures from the paper

Cite This Study

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