Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome

Chronic Coronary Syndrome Clinical Trial

Official title:

Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome: Prospective, Multicentre, Randomized, Open-label, Blinded-endpoint Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06171061
• Other study ID #: GrowfulPower-008
• Status: Recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Coronary Syndrome
• Syndrome

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