Carotid artery plaque intervention with Tongxinluo capsule (CAPITAL): A multicenter randomized double-blind parallel-group placebo-controlled study.

Abstract

To determine whether the traditional Chinese medicine Tongxinluo (TXL) is efficacious at retarding the progression of carotid atherosclerotic lesions, a total of 1,212 patients with a focal intima-media thickness (IMT) of ≥1.2 mm of the carotid arteries received TXL or placebo capsules in addition to current routine therapy. The primary outcome was between-group differences in annualized change in mean IMT of 12 sites of bilateral carotid arteries over 24 months. The secondary outcomes were between-group differences in plaque area, vascular remodeling index (RI), serum levels of lipids and high-sensitivity C-reactive protein, and a composite of first major cardiovascular events. The results showed that the annualized change in mean IMT in the TXL and placebo groups was -0.00095 (95% CI, -0.00330 to 0.00141) mm and 0.01312 (95% CI, 0.01076 to 0.01548) mm, respectively, with a difference between the two groups of -0.01407 (95% CI, -0.01740 to -0.01073) mm (P < 0.001). Compared with placebo, TXL treatment significantly reduced the change from baseline in the plaque area and RI, as well as the first major cardiovascular events. In conclusion, TXL retarded the progression of mean IMT, plaque area and vascular remodeling of the carotid artery with a good safety profile.

• Authors: Mei Zhang, Yan Liu, Mingjun Xu, Lei Zhang, Yan Liu, Xiaoling Liu, Yuxia Zhao, Fang Zhu, Rui Xu, Zhihong Ou, Ying Wang, Qigong Liu, Shuping Ma, Tian Wang, Maolin He, Qinghua Lu, Honghua Li, Jihan Huang, Yun Zhang
• Journal: Scientific reports (Sci Rep) Vol. 9 Issue 1 Pg. 4545 (03 14 2019) ISSN: 2045-2322 [Electronic] England
• PMID: 30872737 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Drugs, Chinese Herbal
• Lipids
• tongxinluo

Topics

• Carotid Arteries (drug effects, pathology)
• Carotid Intima-Media Thickness
• Cohort Studies
• Disease Progression
• Double-Blind Method
• Drugs, Chinese Herbal (therapeutic use)
• Female
• Humans
• Lipids (blood)
• Male
• Middle Aged
• Plaque, Atherosclerotic (drug therapy, pathology)
• Vascular Remodeling (drug effects)