search
Back to results

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

Primary Purpose

Chronic Coronary Syndrome

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Yangxinshi tablet
Yangxinshi tablet simulants
Sponsored by
Dongzhimen Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Coronary Syndrome focused on measuring Cardiopulmonary Exercise Test, Yangxinshi

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All the following criteria must be met to participate in the study: 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) Meet the TCM standard of Qi deficiency and blood stasis syndrome MET < 5 measured by cardiopulmonary exercise test (treadmill) Age between 18 and 75 years (including both age limits), with no limitation on sex Understanding and voluntarily signing the written informed consent Exclusion Criteria: All the following criteria must not be met to participate in the study: Individuals with lower extremity dysfunction, intermittent claudication or severe leg pain who cannot participate in cardiopulmonary exercise tests Individuals with acute coronary syndrome within 1 month after percutaneous coronary intervention (PCI) or within 3 months after coronary artery bypass grafting (CABG) 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 Individuals with a revascularization plan within a month Individuals with left main stenosis ≥50% or proximal left anterior descending (LAD) diameter stenosis ≥90% without PCI or CABG Individuals with absolute and relative contraindications to cardiopulmonary exercise testing (please see Appendix 11 for details) Individuals with New York Heart Association (NYHA) cardiac function class III and IV Individuals with acute cerebrovascular disease Individuals with uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg Individuals found to be in a state of severe anxiety and depression as determined using the GAD-7 and PHQ-9 Individuals with allergies or abnormal drug reactions to the test drugs 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 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) Individuals who have participated in other clinical trials within the past 3 months Individuals unsuitable for the clinical trials, as determined by the researchers

Sites / Locations

  • China-Japan Friendship Hospital
  • Dongzhimen Hospital Beijing University of Chinese Medicine
  • The First Affiliated Hospital of Chongqing Medical University
  • Guangdong Provincial Hospital of Chinese Medicine
  • The First Hospital of Hebei Medical University
  • The First Affiliated Hospital of Henan University of CM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Cardiopulmonary exercise test (treadmill): (MET and peak oxygen uptake)
MET=Metabolic Equivalent of Task

Secondary Outcome Measures

anaerobic threshold
Cardiopulmonary exercise test (treadmill)
oxygen pulse
Cardiopulmonary exercise test (treadmill)
maximal exercise ventilation
Cardiopulmonary exercise test (treadmill)
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
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.
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)
Pittsburgh Sleep Quality Index (PSQI)
score range: 0~21,higher scores mean a worse outcome.
General Anxiety Disorder-7 (GAD-7)
score range: 0~21,higher scores mean a worse outcome.
Patient Health Questionnaire (PHQ-9)
score range: 0-27,higher scores mean a worse outcome.
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.
Hospitalization within 6 months of taking the medicine
total hospitalization time and hospitalization frequency

Full Information

First Posted
July 16, 2023
Last Updated
August 3, 2023
Sponsor
Dongzhimen Hospital, Beijing
search

1. Study Identification

Unique Protocol Identification Number
NCT05978089
Brief Title
Effect of Yangxinshi Tablet on Exercise Tolerance in Patients With Chronic Coronary Syndrome(MET STUDY)
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongzhimen Hospital, Beijing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Coronary Syndrome
Keywords
Cardiopulmonary Exercise Test, Yangxinshi

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Yangxinshi tablet
Intervention Description
The treatment group was given Yangxinshi tablets (3 tablets/time and 3 times/day). The treatment period was 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Yangxinshi tablet simulants
Intervention Description
The control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day).The treatment period was 24 weeks.
Primary Outcome Measure Information:
Title
Cardiopulmonary exercise test (treadmill): (MET and peak oxygen uptake)
Description
MET=Metabolic Equivalent of Task
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
anaerobic threshold
Description
Cardiopulmonary exercise test (treadmill)
Time Frame
24 weeks
Title
oxygen pulse
Description
Cardiopulmonary exercise test (treadmill)
Time Frame
24 weeks
Title
maximal exercise ventilation
Description
Cardiopulmonary exercise test (treadmill)
Time Frame
24 weeks
Title
electrocardiogram (ECG)
Description
Start time and duration determined by 1-mm downward shift in the ST segment on the electrocardiogram (ECG) during the cardiopulmonary exercise test
Time Frame
24 weeks
Title
CCS angina classification
Description
The change in Canadian Cardiovascular Society (CCS) angina scores in all participants. Scoring is via Class I-IV where class IV is worse outcome.
Time Frame
24 weeks
Title
Seattle Angina Questionnaire
Description
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)
Time Frame
24 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
score range: 0~21,higher scores mean a worse outcome.
Time Frame
24 weeks
Title
General Anxiety Disorder-7 (GAD-7)
Description
score range: 0~21,higher scores mean a worse outcome.
Time Frame
24 weeks
Title
Patient Health Questionnaire (PHQ-9)
Description
score range: 0-27,higher scores mean a worse outcome.
Time Frame
24 weeks
Title
Traditional Chinese medicine (TCM) Syndrome Score
Description
the main symptoms score range: 2-6,the secondary symptoms score range: 1-3,higher scores mean a worse outcome.
Time Frame
24 weeks
Title
Hospitalization within 6 months of taking the medicine
Description
total hospitalization time and hospitalization frequency
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Liver function
Description
alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (TBil), and glutamyl transferase (GGT) (γ-GT)
Time Frame
24 weeks
Title
Renal function
Description
blood urea nitrogen (BUN) and serum creatinine (Scr)
Time Frame
24 weeks
Title
Myocardial markers
Description
creatine kinase (CK), troponin I (TnI) (if not available, troponin T (TnT)), and N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time Frame
24 weeks
Title
Blood lipids
Description
cholesterol (CHO), triglyceride (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL)
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All the following criteria must be met to participate in the study: 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) Meet the TCM standard of Qi deficiency and blood stasis syndrome MET < 5 measured by cardiopulmonary exercise test (treadmill) Age between 18 and 75 years (including both age limits), with no limitation on sex Understanding and voluntarily signing the written informed consent Exclusion Criteria: All the following criteria must not be met to participate in the study: Individuals with lower extremity dysfunction, intermittent claudication or severe leg pain who cannot participate in cardiopulmonary exercise tests Individuals with acute coronary syndrome within 1 month after percutaneous coronary intervention (PCI) or within 3 months after coronary artery bypass grafting (CABG) 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 Individuals with a revascularization plan within a month Individuals with left main stenosis ≥50% or proximal left anterior descending (LAD) diameter stenosis ≥90% without PCI or CABG Individuals with absolute and relative contraindications to cardiopulmonary exercise testing (please see Appendix 11 for details) Individuals with New York Heart Association (NYHA) cardiac function class III and IV Individuals with acute cerebrovascular disease Individuals with uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg Individuals found to be in a state of severe anxiety and depression as determined using the GAD-7 and PHQ-9 Individuals with allergies or abnormal drug reactions to the test drugs 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 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) Individuals who have participated in other clinical trials within the past 3 months Individuals unsuitable for the clinical trials, as determined by the researchers
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Xian Lun, Professor
Facility Name
Dongzhimen Hospital Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Xian, Professor
Phone
010-84013203
Email
wx650515@163.com
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Guangdong Provincial Hospital of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Qiu Xiong, Professor
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
The First Affiliated Hospital of Henan University of CM
City
Zhengzhou
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Yong Xia, Professor

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs