Danhong injection in the treatment of chronic stable angina: study protocol for a randomized controlled trial.
BACKGROUND
Chronic stable angina is a leading cause of death worldwide. Danhong injection, a complementary alternative medicine for chronic stable angina, has been demonstrated to be effective in numerous studies and is widely prescribed to patients. However, the methodological quality of most prior studies was found to be, in general, low. Therefore, we designed this randomized controlled trial to evaluate the efficacy and safety of using Danhong injection to treat chronic stable angina.


METHODS
This is a randomized multicentre, double-blind, placebo-controlled, adaptive clinical trial. A total of 870 patients meeting the eligibility criteria will be randomly assigned into either the Danhong injection or the placebo group in a 2:1 ratio. Participants will then undergo a 2-week treatment regimen and a 76-day follow-up period. Because this is an adaptive trial, two interim analyses are prospectively planned. These will be performed after one-third and two-thirds of the patients, respectively, have completed the trial. Based on the results of these interim analyses, a data monitoring committee will determine how to modify aspects of the study without undermining the validity and integrity of the trial. The primary outcome measure is the proportion of patients who show a clinically significant change, which is defined as at least a 20-point improvement in angina frequency score on the Seattle Angina Questionnaire, which will be administered on day 30. Other secondary efficacy and safety outcomes will also be assessed.


CONCLUSIONS
This trial will provide high-quality evidence regarding the use of Danhong injection to treat chronic stable angina.


BACKGROUND
ClinicalTrials.gov: NCT01681316 .
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, Dongzhimen nei, Beijing, 100700, China. pengqian.wang@163.com.
Peng Qian
PQ
Wang
Department of Cardiology, PLA General Hospital, Beijing, 100853, China. 7399253@qq.com.
Dan Dan
DD
Li
Department of Cardiology, PLA General Hospital, Beijing, 100853, China. 301dongw@sina.com.
Wei
W
Dong
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, Dongzhimen nei, Beijing, 100700, China. franlj1104@aliyun.com.
Jun
J
Liu
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, Dongzhimen nei, Beijing, 100700, China. pumpkinnaicha@163.com.
Ya Nan
YN
Yu
Changzhou Traditional Chinese Medicine Hospital, Heping North Road, Changzhou, 213004, Jiangsu, China. czsct@163.com.
Chun Ti
CT
Shen
School of Public Health, Southeast University, Dijia Qiao 87, Nanjing, 210009, Jiangsu, China. chwa2000@sohu.com.
Qi Guang
QG
Chen
School of Public Health, Southeast University, Dijia Qiao 87, Nanjing, 210009, Jiangsu, China. drchenbw@126.com.
Bing Wei
BW
Chen
Department of Cardiology, PLA General Hospital, Beijing, 100853, China. cyundai@126.com.
Yun Dai
YD
Chen
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, Dongzhimen nei, Beijing, 100700, China. zhonw@vip.sina.com.
Zhong
Z
Wang
D000293:Adolescent; D000328:Adult; D000368:Aged; D060050:Angina, Stable / Q000175:diagnosis / Q000188:drug therapy*; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002681:China; D002985:Clinical Protocols; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D002317:Cardiovascular Agents; D004365:Drugs, Chinese Herbal; C540581:danhong