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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI: a Prospective，Muhicenter,Doubleblind, Double-dummy, Randomized, Controlled Trial

Conditions
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Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Yangxinshi
* Drug: Trimetazidine
* Drug: Yangxinshi mimic
* Drug: Trimetazidine mimic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yangxinshi<br> | Drug: Yangxinshi<br>* Yangxinshi pill 3 pills /tid<br>Drug: Trimetazidine mimic<br>* Trimetazidine mimic tablets 20mg/tid<br>|
| Active Comparator: Trimetazidine<br> | Drug: Trimetazidine<br>* Trimetazidine 20mg/tid<br>Drug: Yangxinshi mimic<br>* Yangxinshi mimic tablets 3 pills /tid<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary Exercise Test