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

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: Completed
• Conditions: Percutaneous Coronary Intervention
• Intervention / Treatment: Drug: Yangxinshi; Drug: Trimetazidine mimic; Drug: Trimetazidine; Drug: Yangxinshi mimic

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: Interventional
• Enrollment (Actual): 681
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in METs assessed by the CPET	MET=Metabolic Equivalent of Task; CPET=Cardiopulmonary Exercise Test	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of anaerobic threshold (AT) by CPET		24 weeks
Incidence of major cardiovascular events (MACE)		4,12,24 and 28 weeks
PHQ-9 Depression Scale	PHQ=Patient health questionaire, score range: 0-27	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)	24 weeks
Frequency of angina pectoris		24 weeks
The proportion of METs>7 patients	MET=Metabolic Equivalent of Task	24 weeks
Changes of VO2max by CPET		24 weeks
Changes of VO2/HR by CPET		24 weeks
Changes of VO2/W by CPET		24 weeks
GAD-7 Anxiety Screening Scale	GAD=Generalized Anxiety Disorder, score range: 0~21	24 weeks

Collaborators and Investigators

• Sponsor: Shenyang Northern Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Cardiopulmonary Exercise Test
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Trimetazidine; Yangxinshi
• Other Study ID 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