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

NCT ID: NCT03809273

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 681 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Yangxinshi

Group Type: EXPERIMENTAL

Yangxinshi

Intervention Type: DRUG

Yangxinshi pill 3 pills /tid

Trimetazidine mimic

Intervention Type: DRUG

Trimetazidine mimic tablets 20mg/tid

Trimetazidine

Group Type: ACTIVE_COMPARATOR

Trimetazidine

Intervention Type: DRUG

Trimetazidine 20mg/tid

Yangxinshi mimic

Intervention Type: DRUG

Yangxinshi mimic tablets 3 pills /tid

Interventions

Yangxinshi

Yangxinshi pill 3 pills /tid

Intervention Type: DRUG

Trimetazidine

Trimetazidine 20mg/tid

Intervention Type: DRUG

Yangxinshi mimic

Yangxinshi mimic tablets 3 pills /tid

Intervention Type: DRUG

Trimetazidine mimic

Trimetazidine mimic tablets 20mg/tid

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenyang Northern Hospital

OTHER

Sponsor Role: lead

Responsible Party

Han Yaling

Director, clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Hefei, Anhui, China

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Cangzhou Central Hospital

Cangzhou, Hebei, China

Hebei General Hospital

Shijiazhuang, Hebei, China

Changchun Traditional Medicine University Affiliated Hospital

Changchun, Jilin, China

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Jinan Central Hospital Affiliated to Shandong University

Jinan, Shandong, China

Shandong Provincial Hospital

Jinan, Shandong, China

Qingdao Municipal Hospital

Qingdao, Shandong, China

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 39566404 (View on PubMed)

Other Identifiers

GrowfulPower-001

Identifier Type: -

Identifier Source: org_study_id