Rationale and Design of the Evaluation of Oral Anticoagulation for Reduction of Thrombo-embolism in Chinese Patients with Device-Detected Subclinical Atrial Fibrillation (ART-CAF) Trial: an Open-Label Registry-Based Clinical Trial
| العنوان: | Rationale and Design of the Evaluation of Oral Anticoagulation for Reduction of Thrombo-embolism in Chinese Patients with Device-Detected Subclinical Atrial Fibrillation (ART-CAF) Trial: an Open-Label Registry-Based Clinical Trial |
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| المؤلفون: | Guosheng Fu, Ying Yang, Jiangfen Jiang, Wenbing Jiang, Xia Sheng, Dongmei Jiang, Jiefang Zhang, Linlin Zhao, Yiwen Pan, Leyan Cai, Fen Xu, Jinshan Tong |
| المصدر: | Cardiovascular Drugs and Therapy. 32:389-396 |
| بيانات النشر: | Springer Science and Business Media LLC, 2018. |
| سنة النشر: | 2018 |
| مصطلحات موضوعية: | China, Pacemaker, Artificial, medicine.medical_specialty, Time Factors, Arterial embolism, Clinical Decision-Making, Population, Administration, Oral, 030204 cardiovascular system & hematology, Decision Support Techniques, 03 medical and health sciences, 0302 clinical medicine, Predictive Value of Tests, Risk Factors, Thromboembolism, Internal medicine, Atrial Fibrillation, Humans, Multicenter Studies as Topic, Medicine, Pharmacology (medical), Prospective Studies, Registries, 030212 general & internal medicine, education, Prospective cohort study, Stroke, Subclinical infection, Pharmacology, education.field_of_study, business.industry, Cardiac Pacing, Artificial, Anticoagulants, Atrial fibrillation, General Medicine, medicine.disease, Clinical trial, Treatment Outcome, Asymptomatic Diseases, Feasibility Studies, Cardiology and Cardiovascular Medicine, business, Cohort study |
| الوصف: | Subclinical atrial fibrillation (AF) was found in a large number of pacemaker patients. It is not certain whether there is a similar risk/benefit ratio for oral anticoagulation in patients with subclinical AF compared to patients with similar risk profiles and clinically diagnosed AF. Given the weakness of clinical evidence for oral anticoagulation in patients with device-detected subclinical AF, specific recommendations in most guidelines for this population are scarce and rarely similar. ART-CAF trial was primarily designed to evaluate the efficacy and safety of oral anticoagulant agent use in patients with device-detected subclinical AF at the approved dosage to prevent stroke and systemic arterial embolism. It is an open-label, registry-based, prospective, multicenter, cohort study, recruiting patients with subclinical AF first detected by a pacemaker, implantable cardioverter-defibrillator, or insertable cardiac monitor after device implantation for more than 3 months. The primary outcome is a composite of ischemic stroke and systemic arterial embolism. The primary safety outcome is the occurrence of clinically overt major bleeding. Approximately 750 patients will be needed to be enrolled to the two treatment groups in a 1:1 ratio until 66 primary efficacy outcomes are observed. The anticipated follow-up period is approximately 70 months from the enrollment of the first patient. ART-CAF evaluates the feasibility of selecting high-risk patients suitable for anticoagulation by AF burden combined with CHA2DS2-VASc score after pacemaker implantation and aims to select patients who could benefit from anticoagulation. http://www.chictr.org.cn/index.aspxTest ChiCTR1800016221 |
| تدمد: | 1573-7241 0920-3206 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::20f524fd28c56856ce2850096ad5e8c9Test https://doi.org/10.1007/s10557-018-6807-9Test |
| حقوق: | CLOSED |
| رقم الانضمام: | edsair.doi.dedup.....20f524fd28c56856ce2850096ad5e8c9 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15737241 09203206 |
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