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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06171061
Other study ID # GrowfulPower-008
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date December 18, 2023
Est. completion date December 31, 2026

Study information

Verified date April 2024
Source Shandong First Medical University
Contact Yuan Haitao
Phone 0531-68776356
Email doctoryuanht@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a prospective, multicentre, randomized, open-label, blinded-endpoint clinical trial to evaluate the efficacy and safety of Yangxinshi tablets in the treatment of patients with chronic coronary syndrome (CCS).


Description:

This study plans to enrol 1200 CCS patients. A central randomized control group will be set up. The experimental and control groups will be populated at a 3:1 ratio. In addition to basic medication, the experimental group will be given Yangxinshi tablets (three tablets each time, three times a day); the control group will be given basic medication only. The treatment period is 24 weeks. The primary efficacy indicator is the 6-minute walking distance (6MWD).


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. age 18-75 years; 2. CCS patients in stable condition and clearly diagnosed by coronary artery imaging (at least one vessel stenosis = 50%): stable angina, ischaemic cardiomyopathy, asymptomatic or stable symptoms, occult coronary heart disease, acute coronary syndrome (ACS), or >3 months after coronary revascularization; 3. moderately to severely limited exercise tolerance: the maximum 6MWD is < 450 m, or the metabolic equivalent (MET) as measured by treadmill cardiopulmonary exercise testing is < 5 METs; 4. voluntary participation and signing of informed consent. Exclusion Criteria: 1. absolute or relative contraindications for the treadmill cardiopulmonary exercise test or 6-minute walk test (6MWT); 2. serious primary diseases, mental diseases, or malignant tumours that affect lifespan; 3. pregnancy, intended or suspected pregnancy, miscarriage, breastfeeding, or delivery in the last 6 months; 4. subjects not suitable for this study in the opinion of the researchers, such as subjects who are participating in other drug clinical trials or intervention studies.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Yangxinshi tablet
In addition to basic medication, the experimental group will be given Yangxinshi (three tablets each time, three times a day);The treatment period is 24 weeks.
Other:
Basic medication
The control group will be given basic medication only. The treatment period is 24 weeks.

Locations

Country Name City State
China Binzhou Medical University Hospital Binzhou Shandong
China Binzhou People's Hospital Binzhou Shandong
China Shapingba District People's Hospital of Chongqing Chongqing Chongqing
China Dezhou Municiple Hospital Dezhou Shandong
China Pingyuan County first People's Hospital Dezhou Shandong
China Feicheng People's Hospital Feicheng Shandong
China Shandong Health Group Feicheng Hospital Feicheng Shandong
China Affiliated Hospital of Shandong University of Traditional Chinese Medicine Jinan Shandong
China Jinan Central Hospital Jinan Shandong
China Jinan Zhangqiu District People's Hospital Jinan Shandong
China Shandong Provincial Hospital Affiliated to Shandong First Medical University Jinan Shandong
China The Fourth People's Hospital of Jinan Jinan Shandong
China Gaotang County People's Hospital Liaocheng Shandong
China Liaocheng Hospital of Traditional Chinese Medicine Liaocheng Shandong
China Liaocheng People's Hospital Liaocheng Shandong
China The Second People's Hospital of Liaocheng Liaocheng Shandong
China Linqing City People's Hospital Linqing Shandong
China Linyi People's Hospital Linyi Shandong
China Longkou People Hosptial Longkou Shandong
China Affiliated Hospital of Qingdao University Qingdao Shandong
China Hospital of Cardiovascular Diseases Affiliated to Qingdao University Qingdao Shandong
China Qingdao Central Hospital Qingdao Shandong
China Qingdao Fuwai Hospital Qingdao Shandong
China Qingdao Municipal Hospital Qingdao Shandong
China Shandong University Qilu Hospital Qingdao District Qingdao Shandong
China The Second Affiliated Hospital of Shandong First Medical University Taian Shandong
China Xintai People's Hospital Taian Shandong
China Tengzhou Central People's Hospital Tengzhou Shandong
China Weifang City People's Hospital Weifang Shandong
China Weifang City Yidu Central Hospital Weifang Shandong
China Yantai Hospital of Traditional Chinese Medicine Yantai Shandong
China Zhengzhou Seventh People's Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Shandong First Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 6MWD The 6-min walking distance 24 weeks after treatment
Secondary Borg scale score range: 0~10,higher scores mean a worse outcome. 24 weeks after treatment
Secondary MACCE incidence of major adverse cardiovascular and cerebrovascular events (MACCE) after 4, 8, 12, 16, 20, and 24 weeks of treatment
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