Status:
RECRUITING
Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome
Lead Sponsor:
Shandong First Medical University
Conditions:
Chronic Coronary Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 co...
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, t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT06171061
Start Date
December 18 2023
End Date
December 31 2026
Last Update
April 17 2024
Active Locations (32)
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1
Shapingba District People's Hospital of Chongqing
Chongqing, Chongqing Municipality, China
2
Zhengzhou Seventh People's Hospital
Zhengzhou, Henan, China
3
Binzhou Medical University Hospital
Binzhou, Shandong, China
4
Binzhou People's Hospital
Binzhou, Shandong, China