NCT01523418撤回不适用
Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery or Hip or Knee in Indian Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Bayer
- 主要终点
- Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse events
研究概览
简要总结
The primary objective of this study is to evaluate the safety of Xarelto in the prophylaxis of VTE in Indian patients undergoing elective TKR/THR
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
- •Adult patients of either sex, undergoing elective THR/TKR, in whom, Rivaroxaban is given for thromboprophylaxis
- •Patients willing to give a written informed consent
排除标准
- •Exclusion criteria must be read in conjunction with the local product information
- •Patients on UFH / LMWH therapy, fondaparinux and vitamin K antagonists are not eligible.
- •Patients with history of hypersensitivity to active ingredients or excipient :cellulose microcrystalline, croscarmellose sodium, lactose monohydrate, magnesium stearate, sodium lauryl sulfate
研究组 & 干预措施
Group 1
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
结局指标
主要结局
Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse events
时间窗: 3 months after the day of surgery
Safety related variables are bleeding events reported as major or non-major adverse events
时间窗: 3 months after the day of surgery
All cause mortality
时间窗: 3 months after the day of surgery
次要结局
未报告次要终点
研究者
相似试验
已完成
不适用
Xarelto for VTE Prophylaxis After Hip or Knee ArthroplastyVenous ThromboembolismNCT00831714Bayer19,076
已完成
不适用
Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)Venous ThromboembolismNCT02558465Bayer2,540
已完成
不适用
Xarelto for Thromboprophylaxis After Total Hip and Total Knee ArthroplastyArthroplastyVenous ThromboembolismNCT05449327Chiayi Christian Hospital150
已完成
不适用
Xarelto on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Treatment-naïve Asian Patients With Non-valvular Atrial FibrillationAtrial FibrillationNCT03284762Bayer1,216
已完成
不适用
Study to Gain Information on the Drug Xarelto for the Prevention of Brain Attack and Blockage of an Artery in the Non-central Nervous System Due to Irregular Heartbeat in Taiwanese Patients Suffering From Decreased Renal FunctionNon-valvular Atrial Fibrillation (NVAF)NCT04356989Bayer493