Clinical trial NCT03809273: Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI
Official title: Effects of Yangxinshi Pills on the Exercise Tolerance Compared With Trimetazidine in Patients After PCI: a Prospective，Muhicenter,Doubleblind, Double-dummy, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Percutaneous Coronary Intervention
Keywords: Cardiopulmonary Exercise Test
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 668
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in METs assessed by the CPET
timeFrame: 24 weeks
Secondary outcomes:
measure: Changes of anaerobic threshold (AT) by CPET
timeFrame: 24 weeks
measure: Incidence of major cardiovascular events (MACE)
timeFrame: 4,12,24 and 28 weeks
measure: PHQ-9 Depression Scale
timeFrame: 24 weeks
measure: Changes of Seattle Angina Questionnaire
timeFrame: 24 weeks
measure: Frequency of angina pectoris
timeFrame: 24 weeks
measure: The proportion of METs>7 patients
timeFrame: 24 weeks
measure: Changes of VO2max by CPET
timeFrame: 24 weeks
measure: Changes of VO2/HR by CPET
timeFrame: 24 weeks
measure: Changes of VO2/W by CPET
timeFrame: 24 weeks
measure: GAD-7 Anxiety Screening Scale
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China
state: Anhui
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Changchun
country: China
facility: Changchun Traditional Medicine University Affiliated Hospital
state: Jilin
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Jinan
country: China
facility: Jinan Central Hospital Affiliated to Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
Study officials:
References: