Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI (HEARTRIP)

September 3, 2025 updated by: Han Yaling, Shenyang Northern Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
681

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • The First Affiliated Hospital of University of Science and Technology of China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Peking University People's Hospital
      • Beijing, Beijing Municipality, China
        • Beijing AnZhen Hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • The First Affiliated Hospital of Chongqing Medical University
    • Guangdong
      • Guangzhou, Guangdong, China
        • Guangdong Provincial People's Hospital
    • Hebei
      • Cangzhou, Hebei, China
        • Cangzhou Central Hospital
      • Shijiazhuang, Hebei, China
        • Hebei General Hospital
    • Jilin
      • Changchun, Jilin, China
        • Changchun Traditional Medicine University Affiliated Hospital
    • Liaoning
      • Dalian, Liaoning, China
        • The Second Hospital of Dalian Medical University
      • Shenyang, Liaoning, China, 110016
        • General Hospital of Northern Theater Command
    • Shandong
      • Jinan, Shandong, China
        • Shandong Provincial Hospital
      • Jinan, Shandong, China
        • Jinan Central Hospital Affiliated to Shandong University
      • Qingdao, Shandong, China
        • Qingdao Municipal Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    • Shanxi
      • Taiyuan, Shanxi, China
        • First Hospital of Shanxi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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；

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Yangxinshi
Drug: Yangxinshi
Yangxinshi pill 3 pills /tid
Drug: Trimetazidine mimic
Trimetazidine mimic tablets 20mg/tid
Active Comparator: Trimetazidine
Drug: Trimetazidine
Trimetazidine 20mg/tid
Drug: Yangxinshi mimic
Yangxinshi mimic tablets 3 pills /tid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in METs assessed by the CPET
Time Frame: 24 weeks
MET=Metabolic Equivalent of Task; CPET=Cardiopulmonary Exercise Test
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes of anaerobic threshold (AT) by CPET
Time Frame: 24 weeks
24 weeks
Incidence of major cardiovascular events (MACE)
Time Frame: 4,12,24 and 28 weeks
4,12,24 and 28 weeks
PHQ-9 Depression Scale
Time Frame: 24 weeks
PHQ=Patient health questionaire, score range: 0-27
24 weeks
Changes of Seattle Angina Questionnaire
Time Frame: 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)
24 weeks
Frequency of angina pectoris
Time Frame: 24 weeks
24 weeks
The proportion of METs>7 patients
Time Frame: 24 weeks
MET=Metabolic Equivalent of Task
24 weeks
Changes of VO2max by CPET
Time Frame: 24 weeks
24 weeks
Changes of VO2/HR by CPET
Time Frame: 24 weeks
24 weeks
Changes of VO2/W by CPET
Time Frame: 24 weeks
24 weeks
GAD-7 Anxiety Screening Scale
Time Frame: 24 weeks
GAD=Generalized Anxiety Disorder, score range: 0~21
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenyang Northern Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GrowfulPower-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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