Rivaroxaban Versus Vitamin K-Antagonist (VKA) in Thromboprophylaxis of Patients With Atrial Fibrillation: Patient Preference Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 647
- 主要终点
- A prescription of patient preferences pattern including 5 attributes for Discrete-Choice-Experiment(DCE)-design in patients with atrial fibrillation
研究概览
简要总结
According to recent guidelines, long-term anticoagulation is recommended for patients with atrial fibrillation (AF) and a risk profile with CHA2DS2-VASc score of 1 or more. Vitamin K antagonists(VAK) and novel oral anticoagulants such as rivaroxaban are current treatment options for AF patients with additional risk factors for stroke. Currently there are only limited information to what extend AF patients prefer one or the other treatment option based on patient relevant characteristics of novel oral anticoagulants vs. VKAs. It is also unknown which of the characteristics influences patient preference most and how this relates to a neutral comparator. Furthermore, an additional unknown factor is also how patient evaluate their current treatment and if this leads to differences among treatment with VKAs and rivaroxaban.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A.General Criteria (Group 1and Group2):
- •diagnosed non-valvular AF
- •older than 18 years
- •general capability and willingness to perform a structured patient interview in German
- •no participation in any other clinical or observational study over the last 3 month
- •Additional criteria for Group1 (VKA-experienced):
- •active VKA-therapy for at least 3 month without significant interruptions
- •in case of perioperative interruption VKA treatment should not have been hold for more than two weeks.
- •Additional criteria for Group2 (rivaroxaban-experienced patients):
- •active rivaroxaban-therapy for at least 3 month without significant interruptions
- •in case of perioperative interruption VKA treatment should not have been hold for more than two weeks.
排除标准
- •participation in any other clinical or observational study over the last 3 month
研究组 & 干预措施
Group 1
300 AF patients, with at least 3 month of anticoagulation therapy with VKAs (VKA-experienced patients)
干预措施: Phenprocoumon (Marcumar) (Drug)
Group 2
300 AF patients, with at least 3 month of rivaroxaban therapy (rivaroxaban-experienced patients)
干预措施: Rivaroxaban (Xarelto, BAY-59 7939) (Drug)
结局指标
主要结局
A prescription of patient preferences pattern including 5 attributes for Discrete-Choice-Experiment(DCE)-design in patients with atrial fibrillation
时间窗: Within 1-4 weeks after patient enrollement
Attributes and values in relation to the DCE-Choice-Set. The patient will receive a "test card" with the following attributes: bridging of anticoagulation, regular anticoagulation control, limitations to eating behaviour and alcohol consumption, once vs. twice daily intake of medication, neutral comparator for quantification display of preference: distance to therapy practice
Patient relevant burden/benefit due to anticoagulation using the ACTS-questionnaire
时间窗: At study entry
次要结局
未报告次要终点