Yangxinshi Tablets Versus Trimetazidine on Exercise Tolerance After Percutaneous Coronary Intervention: Rationale and Design of the Double-blind, Randomized HEARTRIP Trial
Improving exercise tolerance is indisputably beneficial for long-term survival in patients treated with percutaneous coronary intervention (PCI). Although previous studies suggested that Yangxinshi tablets effectively improve exercise tolerance in patients with coronary heart disease, the evidence i...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Health/LWW
2023-06-01
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| Series: | Cardiology Discovery |
| Online Access: | http://journals.lww.com/10.1097/CD9.0000000000000094 |
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| author | Yi Li Jian Zhang Hong Chen Yi Zhang Jing Li Haichu Yu Xiaoping Meng Haitao Yuan Lili Shao Yaling Han |
| author_facet | Yi Li Jian Zhang Hong Chen Yi Zhang Jing Li Haichu Yu Xiaoping Meng Haitao Yuan Lili Shao Yaling Han |
| author_sort | Yi Li |
| collection | DOAJ |
| description | Improving exercise tolerance is indisputably beneficial for long-term survival in patients treated with percutaneous coronary intervention (PCI). Although previous studies suggested that Yangxinshi tablets effectively improve exercise tolerance in patients with coronary heart disease, the evidence is limited due to the lack of high-quality randomized trials. The Effects of Yangxinshi Tablets on Exercise Tolerance Compared with Trimetazidine in Patients after PCI (HEARTRIP) trial is a multicenter, double-blind, double-dummy, active drug-controlled, randomized trial designed to test if the effects of Yangxinshi tablets on exercise tolerance are non-inferior to those of trimetazidine in patients undergoing PCI. A total of 668 patients who have undergone PCI for the first time and completed a cardiopulmonary exercise test (CPET) will be enrolled and randomly assigned, in a 1:1 ratio, to receive Yangxinshi tablets (3 tablets, 3 times/d) plus trimetazidine-placebo or trimetazidine (20 mg, 3 times/d) plus Yangxinshi-placebo for 24 weeks. The primary endpoint is metabolic equivalent of tasks (METs) measured by CPET at 24 weeks after randomization. The secondary endpoints include comprehensive CPET indicators, incidence of major adverse cardiac and cerebrovascular events, and depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), and quality of life (Seattle Angina Questionnaire) scores. This study will appraise current clinical evidence on the beneficial effect of Yangxinshi tablets on improving exercise tolerance after PCI and may substantiate their use as an effective pharmacological option for cardiac rehabilitation patients. The HEARTRIP study protocol received approval from the ethics committee of the General Hospital of Northern Theater Command (Shenyang, China). The procedures set out in this protocol are in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results will be published following the guidelines of the CONSORT statement in a peer-reviewed scientific journal (Trial registration number: NCT03809273). |
| format | Article |
| id | doaj-art-2d90161e2d9f4d2bb521b6adcf6c039f |
| institution | DOAJ |
| issn | 2096-952X 2693-8499 |
| language | English |
| publishDate | 2023-06-01 |
| publisher | Wolters Kluwer Health/LWW |
| record_format | Article |
| series | Cardiology Discovery |
| spelling | doaj-art-2d90161e2d9f4d2bb521b6adcf6c039f2025-08-20T03:17:55ZengWolters Kluwer Health/LWWCardiology Discovery2096-952X2693-84992023-06-013212212610.1097/CD9.0000000000000094202306000-00007Yangxinshi Tablets Versus Trimetazidine on Exercise Tolerance After Percutaneous Coronary Intervention: Rationale and Design of the Double-blind, Randomized HEARTRIP TrialYi Li0Jian Zhang1Hong Chen2Yi Zhang3Jing Li4Haichu Yu5Xiaoping Meng6Haitao Yuan7Lili Shao8Yaling Han91 Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China1 Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China2 Department of Cardiology, Peking University People’s Hospital, Beijing 100044, China1 Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China1 Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China3 Department of Cardiology, The Affiliated Hospital of Qingdao University, Qingdao 266071, China4 Department of Cardiology, Affiliated Hospital of Changchun University of Chinese Medicine, Changchun 130021, China5 Department of Cardiology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, China6 Department of Cardiology, The First Hospital of Handan of Hebei Province, Handan 056000, China.1 Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, ChinaImproving exercise tolerance is indisputably beneficial for long-term survival in patients treated with percutaneous coronary intervention (PCI). Although previous studies suggested that Yangxinshi tablets effectively improve exercise tolerance in patients with coronary heart disease, the evidence is limited due to the lack of high-quality randomized trials. The Effects of Yangxinshi Tablets on Exercise Tolerance Compared with Trimetazidine in Patients after PCI (HEARTRIP) trial is a multicenter, double-blind, double-dummy, active drug-controlled, randomized trial designed to test if the effects of Yangxinshi tablets on exercise tolerance are non-inferior to those of trimetazidine in patients undergoing PCI. A total of 668 patients who have undergone PCI for the first time and completed a cardiopulmonary exercise test (CPET) will be enrolled and randomly assigned, in a 1:1 ratio, to receive Yangxinshi tablets (3 tablets, 3 times/d) plus trimetazidine-placebo or trimetazidine (20 mg, 3 times/d) plus Yangxinshi-placebo for 24 weeks. The primary endpoint is metabolic equivalent of tasks (METs) measured by CPET at 24 weeks after randomization. The secondary endpoints include comprehensive CPET indicators, incidence of major adverse cardiac and cerebrovascular events, and depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), and quality of life (Seattle Angina Questionnaire) scores. This study will appraise current clinical evidence on the beneficial effect of Yangxinshi tablets on improving exercise tolerance after PCI and may substantiate their use as an effective pharmacological option for cardiac rehabilitation patients. The HEARTRIP study protocol received approval from the ethics committee of the General Hospital of Northern Theater Command (Shenyang, China). The procedures set out in this protocol are in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results will be published following the guidelines of the CONSORT statement in a peer-reviewed scientific journal (Trial registration number: NCT03809273).http://journals.lww.com/10.1097/CD9.0000000000000094 |
| spellingShingle | Yi Li Jian Zhang Hong Chen Yi Zhang Jing Li Haichu Yu Xiaoping Meng Haitao Yuan Lili Shao Yaling Han Yangxinshi Tablets Versus Trimetazidine on Exercise Tolerance After Percutaneous Coronary Intervention: Rationale and Design of the Double-blind, Randomized HEARTRIP Trial Cardiology Discovery |
| title | Yangxinshi Tablets Versus Trimetazidine on Exercise Tolerance After Percutaneous Coronary Intervention: Rationale and Design of the Double-blind, Randomized HEARTRIP Trial |
| title_full | Yangxinshi Tablets Versus Trimetazidine on Exercise Tolerance After Percutaneous Coronary Intervention: Rationale and Design of the Double-blind, Randomized HEARTRIP Trial |
| title_fullStr | Yangxinshi Tablets Versus Trimetazidine on Exercise Tolerance After Percutaneous Coronary Intervention: Rationale and Design of the Double-blind, Randomized HEARTRIP Trial |
| title_full_unstemmed | Yangxinshi Tablets Versus Trimetazidine on Exercise Tolerance After Percutaneous Coronary Intervention: Rationale and Design of the Double-blind, Randomized HEARTRIP Trial |
| title_short | Yangxinshi Tablets Versus Trimetazidine on Exercise Tolerance After Percutaneous Coronary Intervention: Rationale and Design of the Double-blind, Randomized HEARTRIP Trial |
| title_sort | yangxinshi tablets versus trimetazidine on exercise tolerance after percutaneous coronary intervention rationale and design of the double blind randomized heartrip trial |
| url | http://journals.lww.com/10.1097/CD9.0000000000000094 |
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