Clinical trial NCT06171061: Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome
Official title: Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome: Prospective, Multicentre, Randomized, Open-label, Blinded-endpoint Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Coronary Syndrome
Keywords: Yangxinshi
Chronic Coronary Syndrome
Lead sponsor: Shandong First Medical University
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: 6MWD
timeFrame: 24 weeks after treatment
Secondary outcomes:
measure: Borg scale
timeFrame: 24 weeks after treatment
measure: MACCE
timeFrame: after 4, 8, 12, 16, 20, and 24 weeks of treatment
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Shapingba District People's Hospital of Chongqing
state: Chongqing
city: Zhengzhou
country: China
facility: Zhengzhou Seventh People's Hospital
state: Henan
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Binzhou
country: China
facility: Binzhou People's Hospital
state: Shandong
city: Dezhou
country: China
facility: Dezhou Municiple Hospital
state: Shandong
city: Dezhou
country: China
facility: Pingyuan County first People's Hospital
state: Shandong
city: Feicheng
country: China
facility: Feicheng People's Hospital
state: Shandong
city: Feicheng
country: China
facility: Shandong Health Group Feicheng Hospital
state: Shandong
city: Jinan
country: China
facility: Affiliated Hospital of Shandong University of Traditional Chinese Medicine
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Jinan
country: China
facility: Jinan Zhangqiu District People's Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital Affiliated to Shandong First Medical University
state: Shandong
city: Jinan
country: China
facility: The Fourth People's Hospital of Jinan
state: Shandong
city: Liaocheng
country: China
facility: Gaotang County People's Hospital
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng Hospital of Traditional Chinese Medicine
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Liaocheng
country: China
facility: The Second People's Hospital of Liaocheng
state: Shandong
city: Linqing
country: China
facility: Linqing City People's Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Longkou
country: China
facility: Longkou People Hosptial
state: Shandong
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University
state: Shandong
city: Qingdao
country: China
facility: Hospital of Cardiovascular Diseases Affiliated to Qingdao University
state: Shandong
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Fuwai Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Qingdao
country: China
facility: Shandong University Qilu Hospital Qingdao District
state: Shandong
city: Taian
country: China
facility: The Second Affiliated Hospital of Shandong First Medical University
state: Shandong
city: Taian
country: China
facility: Xintai People's Hospital
state: Shandong
city: Tengzhou
country: China
facility: Tengzhou Central People's Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang City People's Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang City Yidu Central Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Hospital of Traditional Chinese Medicine
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Yuan Haitao
role: PRINCIPAL_INVESTIGATOR
References: