Chronic Coronary SyndromePhase 4NCT05978089
Effect of Yangxinshi Tablet on Exercise Tolerance in Patients With Chronic Coronary Syndrome（MET STUDY）
A Phase 4 study testing Yangxinshi tablet and Yangxinshi tablet simulants in people with Chronic Coronary Syndrome, run by Dongzhimen Hospital, Beijing at 6 sites in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Coronary Syndrome
- What is being tested?
- Yangxinshi tablet and Yangxinshi tablet simulants
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 6 sitesChina
- Study dates
- 8 Nov 2023to Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Li Xianlun, Professor
- Not yet recruiting
Dongzhimen Hospital Beijing University of Chinese Medicine
Beijing, Beijing Municipality
Wang Xian, Professor, 010-84013203, wx650515@163.com
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Luo Suxin, Professor
- Not yet recruiting
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong
Chen Qiuxiong, Professor
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Liu Gang, Professor
- Recruiting
The First Affiliated Hospital of Henan University of CM
Zhengzhou, Henan
Wang Yongxia, Professor
About this 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
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).
Read the 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.
- Conditions
- Chronic Coronary Syndrome
- Being tested
- Yangxinshi tablet, Yangxinshi tablet simulants
- Keywords
- Cardiopulmonary Exercise Test, Yangxinshi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yangxinshi tabletDrug
Also called Yangxinshi
The treatment group was given Yangxinshi tablets (3 tablets/time and 3 times/day). The treatment period was 24 weeks.
Yangxinshi tablet simulantsDrug
The control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day).The treatment period was 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Yangxinshi tablets Receives: Drug: Yangxinshi tablet |
| Control group | Placebo comparator | Yangxinshi tablet simulants Receives: Drug: Yangxinshi tablet simulants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary exercise test (treadmill): (MET and peak oxygen uptake)
MET=Metabolic Equivalent of Task
Measured: 24 weeks
Secondary outcomes (11)
anaerobic threshold
Cardiopulmonary exercise test (treadmill)
Measured: 24 weeks
oxygen pulse
Cardiopulmonary exercise test (treadmill)
Measured: 24 weeks
maximal exercise ventilation
Cardiopulmonary exercise test (treadmill)
Measured: 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
Measured: 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.
Measured: 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)
Measured: 24 weeks
Pittsburgh Sleep Quality Index (PSQI)
score range: 0~21，higher scores mean a worse outcome.
Measured: 24 weeks
General Anxiety Disorder-7 (GAD-7)
score range: 0~21，higher scores mean a worse outcome.
Measured: 24 weeks
Patient Health Questionnaire (PHQ-9)
score range: 0-27，higher scores mean a worse outcome.
Measured: 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.
Measured: 24 weeks
Hospitalization within 6 months of taking the medicine
total hospitalization time and hospitalization frequency
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start8 Nov 2023
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Xian, Dongzhimen Hospital, Beijing
- Investigators
- Wang Xian, Principal investigator, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978089
- Sponsor's protocol ID
- Growful2201YXS
- Status last verified
- Dec 2023
- First submitted
- 16 Jul 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05978089
- Acronym / sponsor ID
- Growful2201YXS
- Conditions
- Chronic Coronary Syndrome
- Keywords
- Cardiopulmonary Exercise Test, Yangxinshi
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Yangxinshi tabletYangxinshi tablets |
| Control group | Placebo comparator | Drug: Yangxinshi tablet simulantsYangxinshi tablet simulants |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yangxinshi tabletAlso: YangxinshiThe treatment group was given Yangxinshi tablets (3 tablets/time and 3 times/day). The treatment period was 24 weeks. | Drug | Treatment group |
| Yangxinshi tablet simulantsThe control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day).The treatment period was 24 weeks. | Drug | Control group |
Primary outcome
Cardiopulmonary exercise test (treadmill): (MET and peak oxygen uptake)
Time frame: 24 weeks
MET=Metabolic Equivalent of Task
11 secondary outcomes
anaerobic threshold
Time frame: 24 weeks
oxygen pulse
Time frame: 24 weeks
maximal exercise ventilation
Time frame: 24 weeks
electrocardiogram (ECG)
Time frame: 24 weeks
CCS angina classification
Time frame: 24 weeks
Seattle Angina Questionnaire
Time frame: 24 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 24 weeks
General Anxiety Disorder-7 (GAD-7)
Time frame: 24 weeks
Patient Health Questionnaire (PHQ-9)
Time frame: 24 weeks
Traditional Chinese medicine (TCM) Syndrome Score
Time frame: 24 weeks
Hospitalization within 6 months of taking the medicine
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Xian principal investigator
Dongzhimen Hospital, Beijing
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Yangxinshi tablet and Yangxinshi tablet simulants in people with Chronic Coronary Syndrome, run by Dongzhimen Hospital, Beijing at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Xian (010-84013276, wx650515@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary exercise test (treadmill): (MET and peak oxygen uptake) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.