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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
681
Yangxinshi pill 3 pills /tid
Trimetazidine 20mg/tid
Yangxinshi mimic tablets 3 pills /tid
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
Change in METs assessed by the CPET
MET=Metabolic Equivalent of Task; CPET=Cardiopulmonary Exercise Test
Time frame: 24 weeks
Changes of anaerobic threshold (AT) by CPET
Time frame: 24 weeks
Incidence of major cardiovascular events (MACE)
Time frame: 4,12,24 and 28 weeks
PHQ-9 Depression Scale
PHQ=Patient health questionaire, score range: 0-27
Time frame: 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)
Time frame: 24 weeks
Frequency of angina pectoris
Time frame: 24 weeks
The proportion of METs>7 patients
MET=Metabolic Equivalent of Task
Time frame: 24 weeks
Changes of VO2max by CPET
Time frame: 24 weeks
Changes of VO2/HR by CPET
Time frame: 24 weeks
Changes of VO2/W by CPET
Time frame: 24 weeks
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Trimetazidine mimic tablets 20mg/tid
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
...and 5 more locations
GAD-7 Anxiety Screening Scale
GAD=Generalized Anxiety Disorder, score range: 0\~21
Time frame: 24 weeks