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
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
Affiliations
Yang Wang
Medical 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, China
Yan Li
Department of Cardiology, Tangdu Hospital, Airforce Medical University, Beijing, China
Lihua Zhang
National 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, China
Ran Liu
Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Wei Wu
Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China
Yang Li
Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Huiping Zhang
Cardiology Department, Beijing Hospital, National Center of Gerontology, Beijing, China
Stuart Pocock
EPH, London School of Hygiene and Tropical Medicine, London, UK
Xinmin Liu
Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Zhinan Lu
Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Taiyang Luo
Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Liang Guo
Department of Cardiovascular Medicine, The First Hospital of China Medical University, Shenyang, China
Fei Yuan
Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Yi-Da Tang
Department 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, China
Yingxuan Zhu
Medical 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, China
Yunfeng Yan
Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Guangyuan Song
Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Zhengming Jiang
Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
SCOPE Investigators
Beijing Anzhen Hospital Affiliated to Capital Medical University, Beijing, Beijing, China
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.
