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

Phase 4

Recruiting

• Conditions: Chronic Coronary Syndrome
• Interventions: Drug: Yangxinshi tablet; Drug: Yangxinshi tablet simulants

• Registration Number: NCT05978089
• Lead Sponsor: Dongzhimen Hospital, Beijing

Brief 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.

Study Timeline

• Study First Submitted: 2023-07-16
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-07
• Study Start: 2023-11-08
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-18
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Yangxinshi tablet	Yangxinshi tablets
Control group	Yangxinshi tablet simulants	Yangxinshi tablet simulants

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary exercise test (treadmill): (MET and peak oxygen uptake)	24 weeks	MET=Metabolic Equivalent of Task

Secondary Outcome Measures

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

Trial Locations

Locations (6)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

The First Affiliated Hospital of Henan University of CM; 🇨🇳 Zhengzhou, Henan, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Dongzhimen Hospital Beijing University of Chinese Medicine; 🇨🇳 Beijing, Beijing, China

Guangdong Provincial Hospital of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

The First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China