Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI
- Conditions
- Percutaneous Coronary Intervention
- Interventions
- Registration Number
- NCT03809273
- Lead Sponsor
- Shenyang Northern Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 668
- 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；
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Yangxinshi Yangxinshi - Yangxinshi Trimetazidine mimic - Trimetazidine Yangxinshi mimic - Trimetazidine Trimetazidine -
- Primary Outcome Measures
Name Time Method Change in METs assessed by the CPET 24 weeks MET=Metabolic Equivalent of Task; CPET=Cardiopulmonary Exercise Test
- Secondary Outcome Measures
Name Time Method 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 PHQ=Patient health questionaire, score range: 0-27
Changes of Seattle Angina Questionnaire 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)
Frequency of angina pectoris 24 weeks The proportion of METs>7 patients 24 weeks MET=Metabolic Equivalent of Task
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 24 weeks GAD=Generalized Anxiety Disorder, score range: 0\~21
Trial Locations
- Locations (15)
Beijing Anzhen Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of University of Science and Technology of China
🇨🇳Hefei, Anhui, China
Hebei General Hospital
🇨🇳Shijiazhuang, Hebei, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Cangzhou Central Hospital
🇨🇳Cangzhou, 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
Qingdao Municipal Hospital
🇨🇳Qingdao, Shandong, China
First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China