Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yangxinshi | Experimental |
| |
| Trimetazidine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yangxinshi | Drug | Yangxinshi pill 3 pills /tid |
| |
| Trimetazidine |
| Measure | Description | Time Frame |
|---|---|---|
| Change in METs assessed by the CPET | MET=Metabolic Equivalent of Task; CPET=Cardiopulmonary Exercise Test | 24 weeks |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Hefei | Anhui | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39566404 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Trimetazidine 20mg/tid |
|
| Yangxinshi mimic | Drug | Yangxinshi mimic tablets 3 pills /tid |
|
| Trimetazidine mimic | Drug | Trimetazidine mimic tablets 20mg/tid |
|
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 |
| 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 | 110016 | 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 |
| ID | Term |
|---|---|
| C000628007 | Yangxinshi |
| D014292 | Trimetazidine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided