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

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Coronary Syndrome
• Intervention / Treatment: Drug: Yangxinshi tablet; Drug: Yangxinshi tablet simulants

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wang Xian; Phone Number: 010-84013276; Email: wx650515@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Li Xianlun, Professor
    • Beijing, Beijing, China
      • Not yet recruiting
      • Dongzhimen Hospital Beijing University of Chinese Medicine
      • Contact: Wang Xian, Professor; Phone Number: 010-84013203; Email: wx650515@163.com
  • Chongqing
    • Chongqing, Chongqing, China
      • Not yet recruiting
      • The First Affiliated Hospital of Chongqing Medical University
      • Contact: Luo Suxin, Professor
  • Guangdong
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Guangdong Provincial Hospital of Chinese Medicine
      • Contact: Chen Qiuxiong, Professor
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The First Hospital of Hebei Medical University
      • Contact: Liu Gang, Professor
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • The First Affiliated Hospital of Henan University of CM
      • Contact: Wang Yongxia, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
10. Individuals found to be in a state of severe anxiety and depression as determined using the GAD-7 and PHQ-9
11. Individuals with allergies or abnormal drug reactions to the test drugs
12. Women of childbearing age who are pregnant or breastfeeding, plan to get pregnant within six months, have a positive pregnancy test, and cannot take effective contraceptive measures during the study period
13. Individuals who have regularly taken YTs, Chinese herbal decoctions or proprietary Chinese medicines with similar curative effects within the past 7 days (please refer to Appendix 12 for the names of proprietary Chinese medicines)
14. Individuals who have participated in other clinical trials within the past 3 months
15. Individuals unsuitable for the clinical trials, as determined by the researchers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Yangxinshi tablets	Drug: Yangxinshi tablet; The treatment group was given Yangxinshi tablets (3 tablets/time and 3 times/day). The treatment period was 24 weeks.; Other Names: Yangxinshi
Placebo Comparator: Control group; Yangxinshi tablet simulants	Drug: Yangxinshi tablet simulants; The control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day).The treatment period was 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiopulmonary exercise test (treadmill): (MET and peak oxygen uptake)	MET=Metabolic Equivalent of Task	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anaerobic threshold	Cardiopulmonary exercise test (treadmill)	24 weeks
oxygen pulse	Cardiopulmonary exercise test (treadmill)	24 weeks
maximal exercise ventilation	Cardiopulmonary exercise test (treadmill)	24 weeks
electrocardiogram (ECG)	Start time and duration determined by 1-mm downward shift in the ST segment on the electrocardiogram (ECG) during the cardiopulmonary exercise test	24 weeks
CCS angina classification	The change in Canadian Cardiovascular Society (CCS) angina scores in all participants. Scoring is via Class I-IV where class IV is worse outcome.	24 weeks
Seattle Angina Questionnaire	The Seattle Angina Questionaire (SAQ) quantifies patients'physical limitations caused by angina. The scale is transformed to a score of 0 to 100, where higher scores indicate better function (less physical limitation)	24 weeks
Pittsburgh Sleep Quality Index (PSQI)	score range: 0~21，higher scores mean a worse outcome.	24 weeks
General Anxiety Disorder-7 (GAD-7)	score range: 0~21，higher scores mean a worse outcome.	24 weeks
Patient Health Questionnaire (PHQ-9)	score range: 0-27，higher scores mean a worse outcome.	24 weeks
Traditional Chinese medicine (TCM) Syndrome Score	the main symptoms score range: 2-6，the secondary symptoms score range: 1-3，higher scores mean a worse outcome.	24 weeks
Hospitalization within 6 months of taking the medicine	total hospitalization time and hospitalization frequency	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver function	alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (TBil), and glutamyl transferase (GGT) (γ-GT)	24 weeks
Renal function	blood urea nitrogen (BUN) and serum creatinine (Scr)	24 weeks
Myocardial markers	creatine kinase (CK), troponin I (TnI) (if not available, troponin T (TnT)), and N-terminal pro-B-type natriuretic peptide (NT-proBNP)	24 weeks
Blood lipids	cholesterol (CHO), triglyceride (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL)	24 weeks

Collaborators and Investigators

• Sponsor: Dongzhimen Hospital, Beijing
• Investigators: Principal Investigator: Wang Xian, Dongzhimen Hospital, Beijing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 16, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cardiopulmonary Exercise Test; Yangxinshi
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: Growful2201YXS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No