Rationale and design of SCOPE trial: a prospective, multicentre, open-label, randomised controlled trial to evaluate the overall efficacy and safety of a short-term anticoagulation strategy versus conventional single antiplatelet therapy in patients with severe aortic stenosis without indications for anticoagulation or dual antiplatelet therapy post-transcatheter aortic valve replacement
Introduction While transcatheter aortic valve replacement (TAVR) has become a well-established standard of care for patients with symptomatic severe aortic stenosis, the optimal antithrombotic strategy post-TAVR remains a subject of debate, particularly in patients without clear indications for anti...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2025-08-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/8/e098551.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849388503576608768 |
|---|---|
| author | Yang Wang Yan Li Lihua Zhang Ran Liu Wei Wu Yang Li Huiping Zhang Stuart Pocock Xinmin Liu Zhinan Lu Taiyang Luo Liang Guo Fei Yuan Yi-Da Tang Yingxuan Zhu Yunfeng Yan Guangyuan Song Zhengming Jiang SCOPE Investigators |
| author_facet | Yang Wang Yan Li Lihua Zhang Ran Liu Wei Wu Yang Li Huiping Zhang Stuart Pocock Xinmin Liu Zhinan Lu Taiyang Luo Liang Guo Fei Yuan Yi-Da Tang Yingxuan Zhu Yunfeng Yan Guangyuan Song Zhengming Jiang SCOPE Investigators |
| author_sort | Yang Wang |
| collection | DOAJ |
| description | Introduction While transcatheter aortic valve replacement (TAVR) has become a well-established standard of care for patients with symptomatic severe aortic stenosis, the optimal antithrombotic strategy post-TAVR remains a subject of debate, particularly in patients without clear indications for anticoagulation or dual antiplatelet therapy. This study aims to investigate the safety and efficacy of rivaroxaban compared with antiplatelet monotherapy in this specific patient population.Methods and analysis This study is designed as a prospective, multicentre, open-label, randomised controlled trial. A total of 454 patients, who have successfully undergone TAVR and do not have indications for long-term anticoagulation or dual antiplatelet therapy, will be consecutively enrolled from seven centres across China. Participants will be randomly assigned to receive either anticoagulation with rivaroxaban (20/15 mg) or conventional antiplatelet therapy (aspirin or clopidogrel) for 1 month. Follow-up evaluations are scheduled at 1, 3, 6 and 12 months post-procedure. After the initial 1-month antithrombotic therapy, the regimen may be adjusted by the investigator based on the patient’s clinical and imaging follow-up results. The primary endpoint is a hierarchical composite of cardiovascular death, first occurrence of myocardial infarction or stroke, first occurrence of life-threatening, disabling or major bleeding, and grade 3 or higher hypo-attenuated leaflet thickening and reduced leaflet motion at 12 months post-TAVR. The win ratio method will be employed to analyse the primary endpoint.Ethics and dissemination This trial was approved by the Ethics Committee of the Beijing AnZhen Hospital. All relevant results will be disseminated through publications in peer-reviewed journals and presentations at conferences.Trial registration number ChiCTR2400087453. |
| format | Article |
| id | doaj-art-4b12ef6beca1415fbcc7ec75cb2a7d80 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-4b12ef6beca1415fbcc7ec75cb2a7d802025-08-20T03:42:18ZengBMJ Publishing GroupBMJ Open2044-60552025-08-0115810.1136/bmjopen-2024-098551Rationale and design of SCOPE trial: a prospective, multicentre, open-label, randomised controlled trial to evaluate the overall efficacy and safety of a short-term anticoagulation strategy versus conventional single antiplatelet therapy in patients with severe aortic stenosis without indications for anticoagulation or dual antiplatelet therapy post-transcatheter aortic valve replacementYang Wang0Yan Li1Lihua Zhang2Ran Liu3Wei Wu4Yang Li5Huiping Zhang6Stuart Pocock7Xinmin Liu8Zhinan Lu9Taiyang Luo10Liang Guo11Fei Yuan12Yi-Da Tang13Yingxuan Zhu14Yunfeng Yan15Guangyuan Song16Zhengming Jiang17SCOPE Investigators18Medical Research and Biometrics Center, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaDepartment of Cardiology, Tangdu Hospital, Airforce Medical University, Beijing, ChinaNational Clinical Research Center for Cardiovascular Diseases, NHC Key Laboratory of Clinical Research for Cardiovascular Medications, State Key Laboratory of Cardiovascular Disease Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, Beijing, ChinaInterventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, ChinaDepartment of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, ChinaInterventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, ChinaCardiology Department, Beijing Hospital, National Center of Gerontology, Beijing, ChinaEPH, London School of Hygiene and Tropical Medicine, London, UKInterventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, ChinaInterventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, ChinaInterventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, ChinaDepartment of Cardiovascular Medicine, The First Hospital of China Medical University, Shenyang, ChinaInterventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, ChinaDepartment of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing, ChinaMedical Research and Biometrics Center, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaInterventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, ChinaInterventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, ChinaInterventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, ChinaBeijing Anzhen Hospital Affiliated to Capital Medical University, Beijing, Beijing, ChinaIntroduction While transcatheter aortic valve replacement (TAVR) has become a well-established standard of care for patients with symptomatic severe aortic stenosis, the optimal antithrombotic strategy post-TAVR remains a subject of debate, particularly in patients without clear indications for anticoagulation or dual antiplatelet therapy. This study aims to investigate the safety and efficacy of rivaroxaban compared with antiplatelet monotherapy in this specific patient population.Methods and analysis This study is designed as a prospective, multicentre, open-label, randomised controlled trial. A total of 454 patients, who have successfully undergone TAVR and do not have indications for long-term anticoagulation or dual antiplatelet therapy, will be consecutively enrolled from seven centres across China. Participants will be randomly assigned to receive either anticoagulation with rivaroxaban (20/15 mg) or conventional antiplatelet therapy (aspirin or clopidogrel) for 1 month. Follow-up evaluations are scheduled at 1, 3, 6 and 12 months post-procedure. After the initial 1-month antithrombotic therapy, the regimen may be adjusted by the investigator based on the patient’s clinical and imaging follow-up results. The primary endpoint is a hierarchical composite of cardiovascular death, first occurrence of myocardial infarction or stroke, first occurrence of life-threatening, disabling or major bleeding, and grade 3 or higher hypo-attenuated leaflet thickening and reduced leaflet motion at 12 months post-TAVR. The win ratio method will be employed to analyse the primary endpoint.Ethics and dissemination This trial was approved by the Ethics Committee of the Beijing AnZhen Hospital. All relevant results will be disseminated through publications in peer-reviewed journals and presentations at conferences.Trial registration number ChiCTR2400087453.https://bmjopen.bmj.com/content/15/8/e098551.full |
| spellingShingle | Yang Wang Yan Li Lihua Zhang Ran Liu Wei Wu Yang Li Huiping Zhang Stuart Pocock Xinmin Liu Zhinan Lu Taiyang Luo Liang Guo Fei Yuan Yi-Da Tang Yingxuan Zhu Yunfeng Yan Guangyuan Song Zhengming Jiang SCOPE Investigators Rationale and design of SCOPE trial: a prospective, multicentre, open-label, randomised controlled trial to evaluate the overall efficacy and safety of a short-term anticoagulation strategy versus conventional single antiplatelet therapy in patients with severe aortic stenosis without indications for anticoagulation or dual antiplatelet therapy post-transcatheter aortic valve replacement BMJ Open |
| title | Rationale and design of SCOPE trial: a prospective, multicentre, open-label, randomised controlled trial to evaluate the overall efficacy and safety of a short-term anticoagulation strategy versus conventional single antiplatelet therapy in patients with severe aortic stenosis without indications for anticoagulation or dual antiplatelet therapy post-transcatheter aortic valve replacement |
| title_full | Rationale and design of SCOPE trial: a prospective, multicentre, open-label, randomised controlled trial to evaluate the overall efficacy and safety of a short-term anticoagulation strategy versus conventional single antiplatelet therapy in patients with severe aortic stenosis without indications for anticoagulation or dual antiplatelet therapy post-transcatheter aortic valve replacement |
| title_fullStr | Rationale and design of SCOPE trial: a prospective, multicentre, open-label, randomised controlled trial to evaluate the overall efficacy and safety of a short-term anticoagulation strategy versus conventional single antiplatelet therapy in patients with severe aortic stenosis without indications for anticoagulation or dual antiplatelet therapy post-transcatheter aortic valve replacement |
| title_full_unstemmed | Rationale and design of SCOPE trial: a prospective, multicentre, open-label, randomised controlled trial to evaluate the overall efficacy and safety of a short-term anticoagulation strategy versus conventional single antiplatelet therapy in patients with severe aortic stenosis without indications for anticoagulation or dual antiplatelet therapy post-transcatheter aortic valve replacement |
| title_short | Rationale and design of SCOPE trial: a prospective, multicentre, open-label, randomised controlled trial to evaluate the overall efficacy and safety of a short-term anticoagulation strategy versus conventional single antiplatelet therapy in patients with severe aortic stenosis without indications for anticoagulation or dual antiplatelet therapy post-transcatheter aortic valve replacement |
| title_sort | rationale and design of scope trial a prospective multicentre open label randomised controlled trial to evaluate the overall efficacy and safety of a short term anticoagulation strategy versus conventional single antiplatelet therapy in patients with severe aortic stenosis without indications for anticoagulation or dual antiplatelet therapy post transcatheter aortic valve replacement |
| url | https://bmjopen.bmj.com/content/15/8/e098551.full |
| work_keys_str_mv | AT yangwang rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT yanli rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT lihuazhang rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT ranliu rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT weiwu rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT yangli rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT huipingzhang rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT stuartpocock rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT xinminliu rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT zhinanlu rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT taiyangluo rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT liangguo rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT feiyuan rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT yidatang rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT yingxuanzhu rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT yunfengyan rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT guangyuansong rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT zhengmingjiang rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf AT scopeinvestigators rationaleanddesignofscopetrialaprospectivemulticentreopenlabelrandomisedcontrolledtrialtoevaluatetheoverallefficacyandsafetyofashorttermanticoagulationstrategyversusconventionalsingleantiplatelettherapyinpatientswithsevereaorticstenosiswithoutindicationsf |