Study design and rationale of the TXL-CAP trial:a randomi-zed,double-blind,placebo-controlled,multicenter clinical tri-al assessing the effect of Tongxinluo capsules on the stability of coronary atherosclerotic plaques
Mei NI1
Yun TI1
Yan QI1
Meng ZHANG1
Dayue Darrel Duan2
Chen YAO3
Zhen-Hua JIA4
Yun ZHANG1
Pei-Li BU1
1.State Key Laboratory for Innovation and Transformation of Luobing Theory;Key Laboratory of Cardiovascular Re-modeling 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,China2.Cen-ter for Phenomics of Traditional Chinese Medicine,Affiliated TCM Hospital Southwest Medical University,Luzhou,China3.Peking University Clinical Research Institute,Peking University,Beijing,China4.National Key Laboratory of Luobing Research and Innovative Chinese Medicine,Shijiazhuang,China;Hebei Yiling Hospital,Key Disciplines of State Administration of TCM for Collateral Disease,Shijiazhuang,China
摘要：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 vulnerabil-ity 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 in-vestigator-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(n=110)or placebo(n=110)for a duration of 12 months.The primary endpoint was the difference in the minimum FCT of the coronary tar-get 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 sys-tem 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.
机标关键词：stabilityclinicaldesigntrialstudyassessingatheroscleroticcapsules
论文发表日期：2025-07-30
在线出版日期：2025-09-16（本平台首次上网日期，不代表文献的发表时间）
页数：10( 615-624 )