Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome
1 other identifier
interventional
1,200
1 country
32
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2023
Typical duration for phase_4
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2023
CompletedFirst Posted
Study publicly available on registry
December 14, 2023
CompletedStudy Start
First participant enrolled
December 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedApril 17, 2024
April 1, 2024
2 years
December 5, 2023
April 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6MWD
The 6-min walking distance
24 weeks after treatment
Secondary Outcomes (2)
Borg scale
24 weeks after treatment
MACCE
after 4, 8, 12, 16, 20, and 24 weeks of treatment
Study Arms (2)
Experimental group
EXPERIMENTALbasic medication + Yangxinshi tablet
Control group
OTHERbasic medication.
Interventions
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.
The control group will be given basic medication only. The treatment period is 24 weeks.
Eligibility Criteria
You may qualify if:
- age 18-75 years;
- 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;
- 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;
- voluntary participation and signing of informed consent.
You may not qualify if:
- absolute or relative contraindications for the treadmill cardiopulmonary exercise test or 6-minute walk test (6MWT);
- serious primary diseases, mental diseases, or malignant tumours that affect lifespan;
- pregnancy, intended or suspected pregnancy, miscarriage, breastfeeding, or delivery in the last 6 months;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Shapingba District People's Hospital of Chongqing
Chongqing, Chongqing Municipality, China
Zhengzhou Seventh People's Hospital
Zhengzhou, Henan, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Binzhou People's Hospital
Binzhou, Shandong, 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
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Yuan Haitao
Shandong Provincial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2023
First Posted
December 14, 2023
Study Start
December 18, 2023
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
April 17, 2024
Record last verified: 2024-04