Ni Mei, Ti Yun, Qi Yan, Zhang Meng, Duan Dayue Darrel, Yao Chen, Jia Zhen-Hua, Zhang Yun, Bu Pei-Li
State Key Laboratory for Innovation and Transformation of Luobing Theory; Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education, Chinese National Health Commission and Chinese Academy of Medical Sciences; Department of Cardiology, Qilu Hospital of Shandong University, Jinan, China.
Center for Phenomics of Traditional Chinese Medicine, Affiliated TCM Hospital Southwest Medical University, Luzhou, China.
J Geriatr Cardiol. 2025 Jul 28;22(7):615-624. doi: 10.26599/1671-5411.2025.07.004.
Recent clinical trials have demonstrated a protective effect in using traditional Chinese medicine Tongxinluo (TXL) capsule to treat atherosclerosis. However, clinical evidence of the effects of TXL treatment on coronary plaque vulnerability is unavailable. In response, we developed this study to investigate the hypothesis that on the basis of statin therapy, treatment with TXL capsule may stabilize coronary lesions in patients with acute coronary syndrome (ACS). The TXL-CAP study was an investigator-initiated, randomized, double-blind clinical trial conducted across 18 medical centers in China. Patients with ACS aging from 18 to 80 years old who had a non-intervened coronary target lesion with a fibrous cap thickness (FCT) < 100 μm and lipid arc > 90° as defined by optical coherence tomography (OCT) were recruited. A total of 220 patients who met the selection criteria but did not meet the exclusion criteria will be finally recruited and randomized to receive treatment with TXL ( = 110) or placebo ( = 110) for a duration of 12 months. The primary endpoint was the difference in the minimum FCT of the coronary target lesion between TXL and placebo groups at the end of the 12-month follow-up. Secondary endpoints included: (1) changes of the maximum lipid arc and length of the target plaque, and the percentage of lipid, fibrous, and calcified plaques at the end of the 12-month period; (2) the incidence of composite cardiovascular events and coronary revascularization within the 12 months; (3) changes in the grade and scores of the angina pectoris as assessed using the Canadian Cardiovascular Society (CCS) grading system and Seattle angina questionnaire (SAQ) score, respectively; and (4) changes in hs-CRP serum levels. The results of the TXL-CAP trial will provide additional clinical data for revealing whether TXL capsules stabilizes coronary vulnerable plaques in Chinese ACS patients.
近期临床试验已证明，使用中药通心络（TXL）胶囊治疗动脉粥样硬化具有保护作用。然而，TXL治疗对冠状动脉斑块易损性影响的临床证据尚不可得。为此，我们开展了本研究，以探讨在他汀类药物治疗基础上，TXL胶囊治疗可能使急性冠状动脉综合征（ACS）患者冠状动脉病变稳定这一假说。TXL-CAP研究是一项由研究者发起的、随机、双盲临床试验，在中国18个医学中心开展。招募年龄在18至80岁之间、经光学相干断层扫描（OCT）定义为具有纤维帽厚度（FCT）<100μm且脂质弧>90°的未干预冠状动脉靶病变的ACS患者。最终共招募220例符合入选标准但不符合排除标准的患者，并随机分为接受TXL治疗组（n = 110）或安慰剂组（n = 110），治疗持续12个月。主要终点是12个月随访结束时TXL组与安慰剂组冠状动脉靶病变最小FCT的差异。次要终点包括：（1）12个月末靶斑块最大脂质弧、长度的变化，以及脂质、纤维和钙化斑块的百分比；（2）12个月内复合心血管事件和冠状动脉血运重建的发生率；（3）分别使用加拿大心血管学会（CCS）分级系统和西雅图心绞痛问卷（SAQ）评分评估的心绞痛分级和评分的变化；（4）hs-CRP血清水平的变化。TXL-CAP试验结果将为揭示TXL胶囊是否能稳定中国ACS患者冠状动脉易损斑块提供更多临床数据。
