Clinical Study for Safety Evaluation of GXN Tablets Combined with Aspirin in Long-Term Treatment of Coronary Heart Disease

• Published in: Evidence-based complementary and alternative medicine 2021, Vol.2021, p.6658704-8
• Main Authors: Zi, Mingjie, Li, Ruiqi, Lu, Fang, Li, Qingna, Zhao, Yang, Jia, Huijuan, Sun, Mingyue, Yang, Qiaoning, Qiu, Panbo, Wei, Eryang, Wang, Shuge, Li, Rui, Zhang, Wantong, Cao, Weiyi, Li, Yanling, Xu, Hao, Gao, Rui
• Format: Article
• Language: English
• Subjects: Adverse events; Alternative medicine; Angina; Angina pectoris; Antiplatelet therapy; Aspirin; Bleeding; Blood circulation; Cardiovascular disease; Chinese medicine; Clinical significance; Clinical trials; Clopidogrel; Coronary artery disease; Drugs; Gastrointestinal diseases; Heart; Heart diseases; Hospitals; Laboratories; Patients; Population studies; Prevention; Side effects; Statistical analysis; Tablets; Traditional Chinese medicine
• ISSN: 1741-427X; 1741-4288
• DOI: 10.1155/2021/6658704

Background. GXN tablets are composed of Danshen and Chuanxiong, with the functions of activating blood circulation, removing blood stasis, invigorating the pulse, and nourishing the heart, which are used for CHD patients with stable exertional angina Grade I or II (according to traditional Chinese medicine, it is a syndrome of heart and blood stasis with chest pain and dark purple lips and tongue). Clinical trials have shown satisfactory effects on coronary heart disease (CHD). 90.6% of Chinese patients with CHD use both Western medicine and Chinese medicine with the latter being thought to promote blood circulation and remove blood stasis. Some researchers doubt that the combination of Chinese medicine increases the risk of bleeding. The main objective of this study is to observe the safety of long-term use of Guanxinning (hereafter referred to as GXN) tablets combined with aspirin. Methods. The study population is patients with CHD after percutaneous coronary intervention (PCI). Randomization was performed for patients with stable CHD who received dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel or ticagrelor for more than 12 months and then switched to the treatment with aspirin alone for 1 month. This study includes a total of 3,595 subjects in 63 hospitals. The experimental group took aspirin orally (100 mg, 1 time/day) + GXN tablets (0–6 months: 4 tablets/time, 3 times/day; 7–12 months, 4 tablets/time, 2 times/day), and the control group received oral aspirin (100 mg, 1 time/day). Major observation indicators are the incidence of bleeding events, adverse events (AEs), and adverse reactions. The primary endpoint indicators are the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) and the MACCE composite endpoint. Results. A total of 31 cases of symptomatic bleeding were found in the two groups, including 21 cases (0.98%) in the experimental group and 10 cases (0.86%) in the control group; the difference between the two groups was not statistically significant. There were 29 cases (1.35%) of bleeding not reaching BARC type 1 in the experimental group. No attention was paid to the laboratory indicators in the control group during the trial process, so the bleeding as a laboratory indicator between the two groups was not comparable. For BARC type 3–5 bleeding events, there were 3 cases in the experimental group (0.139%) and 2 cases in the control group (0.172%); the difference between the two groups was not statis