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

NCT03809273 | Completed Phase 4

• 1 other identifier: GrowfulPower-001
• Study Type: interventional
• Target: 681
• Locations: 1 country
• Sites: 15

Brief 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 mimic tablets.

Conditions

Percutaneous Coronary Intervention

Keywords

Cardiopulmonary Exercise Test

Outcome Measures

Primary Outcomes (1)

• Change in METs assessed by the CPET

  MET=Metabolic Equivalent of Task; CPET=Cardiopulmonary Exercise Test

  24 weeks

Secondary Outcomes (10)

• 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

  24 weeks

• Changes of Seattle Angina Questionnaire

  24 weeks

• Frequency of angina pectoris

  24 weeks

Study Arms (2)

Yangxinshi

EXPERIMENTAL

Drug: Yangxinshi; Drug: Trimetazidine mimic

Trimetazidine

ACTIVE COMPARATOR

Drug: Trimetazidine; Drug: Yangxinshi mimic

Interventions

Yangxinshi DRUG

Yangxinshi pill 3 pills /tid

Yangxinshi

Trimetazidine DRUG

Trimetazidine 20mg/tid

Trimetazidine

Yangxinshi mimic DRUG

Yangxinshi mimic tablets 3 pills /tid

Trimetazidine

Trimetazidine mimic DRUG

Trimetazidine mimic tablets 20mg/tid

Yangxinshi

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

Study Sites (15)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Location

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

Cangzhou Central Hospital

Cangzhou, Hebei, China

Location

Hebei General Hospital

Shijiazhuang, Hebei, China

Location

Changchun Traditional Medicine University Affiliated Hospital

Changchun, Jilin, China

Location

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110016, China

Location

Jinan Central Hospital Affiliated to Shandong University

Jinan, Shandong, China

Location

Shandong Provincial Hospital

Jinan, Shandong, China

Location

Qingdao Municipal Hospital

Qingdao, Shandong, China

Location

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Related Publications (1)

• 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.

  PMID: 39566404 BACKGROUND

MeSH Terms

Interventions

Yangxinshi; Trimetazidine

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, clinical professor

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 18, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)