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).