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Effect of Yangxinshi Tablet on Exercise Tolerance in Patients With Chronic Coronary Syndrome（MET STUDY） | Clinical Trials | Clareo Health

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Effect of Yangxinshi Tablet on Exercise Tolerance in Patients With Chronic Coronary Syndrome（MET STUDY）

Efficacy and Safety of Yangxinshi Tablet in Improving Exercise Tolerance in Patients With Chronic Coronary Syndrome(Qi Deficiency and Blood Stasis Syndrome):A Randomized, Double-blind,Placebo-parallel-controlled,Multicenter Clinical Study

NCT05978089•Dongzhimen Hospital, Beijing

View on ClinicalTrials.gov

Summary

This study adopted a randomized, double-blind, placebo-controlled, multicenter clinical design and compared the effects of Yangxinshi tablet and placebo on exercise tolerance in patients with chronic coronary syndrome (CCS).

Detailed Description

The aim of the research is to find out if the addition of Yangxinshi tablets on the basis of conventional treatment can improve exercise tolerance of patients with chronic coronary syndrome (CCS), improve quality of life and mental health. A total of 120 qualified CCS patients were randomly divided into two groups. In addition to conventional treatment, the experimental group was given Yangxinshi tablets (3 tablets/time and 3 times/day), and the control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day). The treatment period was 24 weeks. The primary endpoints were metabolic equivalents (METs), and peak oxygen uptake measured by cardiopulmonary exercise testing after 24 weeks of treatment.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All the following criteria must be met to participate in the study:
•1. Meet the diagnostic criteria for CCS in Western medicine; stable coronary heart disease (CHD) with a degree of coronary stenosis ≥50% by angiography or computed tomography angiography (CTA) (including patients with more than 1 year of revascularization)
•2. Meet the TCM standard of Qi deficiency and blood stasis syndrome
•3. MET \< 5 measured by cardiopulmonary exercise test (treadmill)
•4. Age between 18 and 75 years (including both age limits), with no limitation on sex
•5. Understanding and voluntarily signing the written informed consent

Exclusion Criteria

•All the following criteria must not be met to participate in the study:
•1. Individuals with lower extremity dysfunction, intermittent claudication or severe leg pain who cannot participate in cardiopulmonary exercise tests
•2. Individuals with acute coronary syndrome within 1 month after percutaneous coronary intervention (PCI) or within 3 months after coronary artery bypass grafting (CABG)
•3. Individuals with serious primary diseases related to the liver, kidney, and hematopoietic system, acute infectious diseases, and mental illness and individuals with other diseases who are not suitable for cardiopulmonary exercise tests
•4. Individuals with a revascularization plan within a month
•5. Individuals with left main stenosis ≥50% or proximal left anterior descending (LAD) diameter stenosis ≥90% without PCI or CABG
•6. Individuals with absolute and relative contraindications to cardiopulmonary exercise testing (please see Appendix 11 for details)
•7. Individuals with New York Heart Association (NYHA) cardiac function class III and IV
•8. Individuals with acute cerebrovascular disease
•9. Individuals with uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg
+6 more criteria

Locations (6)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Dongzhimen Hospital Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The First Affiliated Hospital of Henan University of CM

Zhengzhou, Henan, China

Key Dates

Start Date

November 8, 2023

Primary Completion Date

June 1, 2025

Completion Date

December 1, 2025

Last Updated

December 18, 2023

Enrollment

120

ESTIMATED participants

Conditions

Chronic Coronary Syndrome

Interventions

Yangxinshi tablet

DRUG

Yangxinshi tablet simulants

DRUG

Contacts

Wang Xian

CONTACT

010-84013276 wx650515@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effect of Yangxinshi Tablet on Exercise Tolerance in Patients With Chronic Coronary Syndrome（MET STUDY）

Inclusion Criteria

Exclusion Criteria

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