Format

Send to

Choose Destination
Sci Rep. 2019 Mar 14;9(1):4545. doi: 10.1038/s41598-019-41118-z.

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

Author information

1
Department of Cardiology, Qilu Hospital of Shandong University, Jinan, China.
2
Department of Cardiology, People's Hospital of Liaoning Province, Shen Yang, China.
3
Department of Cardiology, Shandong Provincial Qianfoshan Hospital, Jinan, China.
4
Department of Cardiology, People's Hospital of Linyi City, Lin Yi, China.
5
Department of Cardiology, Second Affiliated Hospital of Shandong Traditional Chinese Medicine University, Jinan, China.
6
Department of Cardiology, Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.
7
Department of Cardiology, Hebei Provincial People's Hospital, Shi Jiazhuang, China.
8
Department of Cardiology, Traffic Hospital of Shandong Province, Jinan, China.
9
Department of Cardiology, Beijing Shijitan Hospital, Beijing, China.
10
Department of Cardiology, Second Affiliated Hospital of Shandong University, Jinan, China.
11
Department of Cardiology, Wuhan General Hospital of Guangzhou Military Region, Wuhan, China.
12
Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
13
Department of Cardiology, Qilu Hospital of Shandong University, Jinan, China. zhangyun@sdu.edu.cn.

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.

Supplemental Content

Full text links

Icon for Nature Publishing Group Icon for PubMed Central
Loading ...
Support Center