Percutaneous Coronary InterventionPhase 4HEARTRIPNCT03809273
Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI
A Phase 4 study testing Yangxinshi, Trimetazidine and Yangxinshi mimic in people with Percutaneous Coronary Intervention, run by Shenyang Northern Hospital at 15 sites in China.
Trial summary
This study compared the effect of Yangxinshi on exercise tolerance of patients with percutaneous coronary intervention (PCI) for the first time with Trimetazidine.Half of participants will receive Yangxinshi and Trimetazidine mimic tablets in combination,While the other half will receive Trimetazidine and Yangxinshi… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- Yangxinshi, Trimetazidine and Yangxinshi mimic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 681 participants
- Where
- 15 sitesChina
- Study dates
- 1 Aug 2019to 31 Dec 2020
- 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
- Age 18~ 75, gender is not limited；
- The patient within two month after PCI operation for the first time；
- The patient had 1-2 coronary artery lesions with complete revascularization：At least one drug eluting stent was implanted，and residual coronary artery stenosis after PCI <30%；
- Have not revascularization plan within 6 months；
- After being evaluated by clinicians on aerobic exercise ability，patients can carry out early rehabilitation in hospital and exercise cardiopulmonary rehabilitation outside the hospital；
- Coronary heart disease patients with Qi Deficiency and Blood Stasis Syndrome；
- Participants voluntarily participated in and signed informed consent；
Who cannot join
- Patients was diagnosed with AMI as the first diagnosis in the past month, and then hospitalized for PCI operation；
- Patients with absolute and relative contraindications in cardiopulmonary exercise test；
- Any drug allergy to Yangxinshi pill and trimetazidine；
- Patients have taken regular Yangxinshi pill, trimetazidine or other Chinese patent medicine regularly in the past month；
- Patients are intolerant of aspirin, clopidogrel, statins, beta blockers or ACEI drugs (such as massive hemorrhage, severe hypotension, etc.)；
- History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown type) or lower extremity arterial disease in the past 6 months
Show all 14Show fewer
- Active bleeding disease within 6 months；
- Combined with severe liver and kidney dysfunction (creatinine clearance ≤ 30ml / min or in the active stage of kidney disease, serum aminotransferase ≥ 3 × upper limit of clinical reference), other lifethreatening serious primary or psychiatric diseases and malignant tumors
- Hemoglobin <90 g/L；
- Cardiac function (NYHA) grade IV or echocardiography LVEF < 30%；
- Venous blood pressure <100/60 mmHg；
- In past 6 months, have medical history of: pregnancy, prepare or suspected of pregnancy, abortion, breastfeeding or after childbirth
- The expected survival period is less than one year.；
- Patients who are participating in other clinical studies.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing, Beijing Municipality
Cangzhou Central Hospital
Cangzhou, Hebei
Changchun Traditional Medicine University Affiliated Hospital
Changchun, Jilin
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
The Second Hospital of Dalian Medical University
Dalian, Liaoning
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong
Shandong Provincial Hospital
Jinan, Shandong
Qingdao Municipal Hospital
Qingdao, Shandong
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016
Hebei General Hospital
Shijiazhuang, Hebei
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
About this study
Official title: Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI: a Prospective，Muhicenter,Doubleblind, Double-dummy, Randomized, Controlled Trial
This study compared the effect of Yangxinshi on exercise tolerance of patients with percutaneous coronary intervention (PCI) for the first time with Trimetazidine.Half of participants will receive Yangxinshi and Trimetazidine mimic tablets in combination,While the other half will receive Trimetazidine and Yangxinshi mimic tablets.
Read the detailed description
The Primary Purpose of this study is to compare the effect of Yangxinshi on exercise tolerance of patients with percutaneous coronary intervention (PCI) for the first time with Trimetazidine, The target patients are the people who underwent PCI for the first time and can be carried on Cardiopulmonary exercise test. The treatment period was 24 weeks. The patients were randomly divided into two groups.： A: Yangxinshi pill 3 pills /tid and Trimetazidine mimic tablets 20mg/tid B: Trimetazidine mimic tablets 20mg/tid and Yangxinshi pill 3 pills /tid The patients were followed up for 0 weeks, 4 weeks, 12 weeks, 24 weeks and 28 weeks after entering the group.
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- Yangxinshi, Trimetazidine, Yangxinshi mimic, Trimetazidine mimic
- Keywords
- Cardiopulmonary Exercise Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YangxinshiDrug
Yangxinshi pill 3 pills /tid
TrimetazidineDrug
Trimetazidine 20mg/tid
Yangxinshi mimicDrug
Yangxinshi mimic tablets 3 pills /tid
Trimetazidine mimicDrug
Trimetazidine mimic tablets 20mg/tid
| Study group | Role | What they receive |
|---|---|---|
| Yangxinshi | Experimental | Not described Receives: Drug: Yangxinshi; Drug: Trimetazidine mimic |
| Trimetazidine | Active comparator | Not described Receives: Drug: Trimetazidine; Drug: Yangxinshi mimic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in METs assessed by the CPET
MET=Metabolic Equivalent of Task; CPET=Cardiopulmonary Exercise Test
Measured: 24 weeks
Secondary outcomes (10)
Changes of anaerobic threshold (AT) by CPET
Measured: 24 weeks
Incidence of major cardiovascular events (MACE)
Measured: 4,12,24 and 28 weeks
PHQ-9 Depression Scale
PHQ=Patient health questionaire, score range: 0-27
Measured: 24 weeks
Changes of 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
Frequency of angina pectoris
Measured: 24 weeks
The proportion of METs>7 patients
MET=Metabolic Equivalent of Task
Measured: 24 weeks
Changes of VO2max by CPET
Measured: 24 weeks
Changes of VO2/HR by CPET
Measured: 24 weeks
Changes of VO2/W by CPET
Measured: 24 weeks
GAD-7 Anxiety Screening Scale
GAD=Generalized Anxiety Disorder, score range: 0~21
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 posted18 Jan 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies 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
- 681 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809273
- Sponsor's protocol ID
- GrowfulPower-001
- Acronym
- HEARTRIP
- Status last verified
- Sep 2025
- First submitted
- 3 Jan 2019
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Y, Li Y, Zhang Z, Zhang J, Chen H, Yu H, Meng X, Yuan H, Shao L, Lu Y, Liu B, Xu J, Zhang Y, Li J, Han Y; HEARTRIP investigators. Efficacy and safety of yangxinshi versus trimetazidine on exercise tolerance in patients with coronary heart disease after percutaneous coronary intervention: Multicenter, double-blind clinical trial. Phytomedicine. 2024 Dec;135:156198. doi: 10.1016/j.phymed.2024.156198. Epub 2024 Nov 7.
PubMed 39566404
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI: a Prospective，Muhicenter,Doubleblind, Double-dummy, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03809273
- Acronym / sponsor ID
- HEARTRIP / GrowfulPower-001
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- Cardiopulmonary Exercise Test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 681 participants (actual)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 Jan 2019 (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 compared the effect of Yangxinshi on exercise tolerance of patients with percutaneous coronary intervention (PCI) for the first time with Trimetazidine.Half of participants will receive Yangxinshi and Trimetazidine mimic tablets in combination,While the other half will receive Trimetazidine and Yangxinshi mimic tablets.
Detailed description
The Primary Purpose of this study is to compare the effect of Yangxinshi on exercise tolerance of patients with percutaneous coronary intervention (PCI) for the first time with Trimetazidine, The target patients are the people who underwent PCI for the first time and can be carried on Cardiopulmonary exercise test. The treatment period was 24 weeks. The patients were randomly divided into two groups.： A: Yangxinshi pill 3 pills /tid and Trimetazidine mimic tablets 20mg/tid B: Trimetazidine mimic tablets 20mg/tid and Yangxinshi pill 3 pills /tid The patients were followed up for 0 weeks, 4 weeks, 12 weeks, 24 weeks and 28 weeks after entering the group.
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 |
|---|---|---|
| Yangxinshi | Experimental | Drug: Yangxinshi, Drug: Trimetazidine mimic |
| Trimetazidine | Active comparator | Drug: Trimetazidine, Drug: Yangxinshi mimic |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18~ 75, gender is not limited；
- The patient within two month after PCI operation for the first time；
- The patient had 1-2 coronary artery lesions with complete revascularization：At least one drug eluting stent was implanted，and residual coronary artery stenosis after PCI <30%；
- Have not revascularization plan within 6 months；
- After being evaluated by clinicians on aerobic exercise ability，patients can carry out early rehabilitation in hospital and exercise cardiopulmonary rehabilitation outside the hospital；
Key exclusion criteria (14 listed)
- Patients was diagnosed with AMI as the first diagnosis in the past month, and then hospitalized for PCI operation；
- Patients with absolute and relative contraindications in cardiopulmonary exercise test；
- Any drug allergy to Yangxinshi pill and trimetazidine；
- Patients have taken regular Yangxinshi pill, trimetazidine or other Chinese patent medicine regularly in the past month；
- Patients are intolerant of aspirin, clopidogrel, statins, beta blockers or ACEI drugs (such as massive hemorrhage, severe hypotension, etc.)；
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 |
|---|---|---|
| YangxinshiYangxinshi pill 3 pills /tid | Drug | Yangxinshi |
| TrimetazidineTrimetazidine 20mg/tid | Drug | Trimetazidine |
| Yangxinshi mimicYangxinshi mimic tablets 3 pills /tid | Drug | Trimetazidine |
| Trimetazidine mimicTrimetazidine mimic tablets 20mg/tid | Drug | Yangxinshi |
Primary outcome
Change in METs assessed by the CPET
Time frame: 24 weeks
MET=Metabolic Equivalent of Task; CPET=Cardiopulmonary Exercise Test
10 secondary outcomes
Changes of anaerobic threshold (AT) by CPET
Time frame: 24 weeks
Incidence of major cardiovascular events (MACE)
Time frame: 4,12,24 and 28 weeks
PHQ-9 Depression Scale
Time frame: 24 weeks
Changes of Seattle Angina Questionnaire
Time frame: 24 weeks
Frequency of angina pectoris
Time frame: 24 weeks
The proportion of METs>7 patients
Time frame: 24 weeks
Changes of VO2max by CPET
Time frame: 24 weeks
Changes of VO2/HR by CPET
Time frame: 24 weeks
Changes of VO2/W by CPET
Time frame: 24 weeks
GAD-7 Anxiety Screening Scale
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Results publication: PubMed 39566404Li Y, Li Y, Zhang Z, Zhang J, Chen H, Yu H, Meng X, Yuan H, Shao L, Lu Y, Liu B, Xu J, Zhang Y, Li J, Han Y; HEARTRIP investigators. Efficacy and safety of yangxinshi versus trimetazidine on exercise tolerance in patients with coronary heart disease after percutaneous coronary intervention: Multicenter, double-blind clinical trial. Phytomedicine. 2024 Dec;135:156198. doi: 10.1016/j.phymed.2024.156198. Epub 2024 Nov 7.
- Individual participant dataSharing planned: No
Related trials for Percutaneous Coronary Intervention
Not yet recruiting
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Coronary Artery Disease, De Novo Stenosis Lesion
Recruiting
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
RecruitingPhase 3
Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
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.
The record lists no contact. Use the official record to reach the sponsor.
15 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, Trimetazidine and Yangxinshi mimic in people with Percutaneous Coronary Intervention, run by Shenyang Northern Hospital at 15 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 7 inclusion and 14 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: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in METs assessed by the CPET (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03809273, which also lists 1 linked publication.
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 10 Sep 2025.