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

Chronic Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978089
• Other study ID #: Growful2201YXS
• Status: Recruiting
• Phase: Phase 4
• Start date: November 8, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Dongzhimen Hospital, Beijing
• Contact: Wang Xian
• Phone: 010-84013276
• Email: wx650515[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Coronary Syndrome
• Syndrome

Intervention

Drug:
• Yangxinshi tablet
The treatment group was given Yangxinshi tablets (3 tablets/time and 3 times/day). The treatment period was 24 weeks.
• Yangxinshi tablet simulants
The control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day).The treatment period was 24 weeks.

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Dongzhimen Hospital Beijing University of Chinese Medicine	Beijing	Beijing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
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

Sponsors (1)

Lead Sponsor	Collaborator
Dongzhimen Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Liver function	alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (TBil), and glutamyl transferase (GGT) (?-GT)	24 weeks
Other	Renal function	blood urea nitrogen (BUN) and serum creatinine (Scr)	24 weeks
Other	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
Other	Blood lipids	cholesterol (CHO), triglyceride (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL)	24 weeks
Primary	Cardiopulmonary exercise test (treadmill): (MET and peak oxygen uptake)	MET=Metabolic Equivalent of Task	24 weeks
Secondary	anaerobic threshold	Cardiopulmonary exercise test (treadmill)	24 weeks
Secondary	oxygen pulse	Cardiopulmonary exercise test (treadmill)	24 weeks
Secondary	maximal exercise ventilation	Cardiopulmonary exercise test (treadmill)	24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Pittsburgh Sleep Quality Index (PSQI)	score range: 0~21,higher scores mean a worse outcome.	24 weeks
Secondary	General Anxiety Disorder-7 (GAD-7)	score range: 0~21,higher scores mean a worse outcome.	24 weeks
Secondary	Patient Health Questionnaire (PHQ-9)	score range: 0-27,higher scores mean a worse outcome.	24 weeks
Secondary	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
Secondary	Hospitalization within 6 months of taking the medicine	total hospitalization time and hospitalization frequency	24 weeks