Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 8,101
- 试验地点
- 13
- 主要终点
- Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days
研究概览
简要总结
This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.
详细描述
The treatment period was followed by a follow-up period starting the day after the last intake of study medication, regardless of the actual duration of study drug administration and ended on Day 90 (+ 7 days). Participants who did not complete the treatment period also entered the follow-up period. It was also possible that participants did not enter the follow-up period, e.g. due to withdrawal of consent or termination of study participation.
Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 40 years or more
- •Patients at risk of venous thromboembolic events being hospitalized for acute medical conditions as follows:
- •Heart failure, New York Heart Association (NYHA) class III or IV
- •Active cancer
- •Acute ischemic stroke
- •Acute infectious and inflammatory diseases, including acute rheumatic diseases
- •Acute respiratory insufficiency
- •Additional risk factor for VTE, including reduced mobility
排除标准
- •Conditions that contraindicate the use of antithrombotic therapy with the Low Molecular-Weight Heparin (LMWH) enoxaparin
- •Conditions that may increase the risk of bleeding, including intracranial hemorrhage
- •Required drugs or procedures which may interfere with the study treatment
- •Concomitant conditions or diseases which may increase the risk of study subjects or interfere with the study outcome
- •General conditions in which subjects are not suitable to participate in the study
研究组 & 干预措施
Rivaroxaban (Xarelto, BAY59-7939)
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Rivaroxaban (Xarelto, BAY59-7939)
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
干预措施: Enoxaparin placebo (Drug)
Enoxaparin
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
干预措施: Enoxaparin (Drug)
Enoxaparin
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
干预措施: Rivaroxaban placebo (Drug)
结局指标
主要结局
Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days
时间窗: Up to Day 35 + 6 days
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days
时间窗: Up to Day 10 + 5 days
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
次要结局
- Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days(Up to Day 35 + 6 days)
- Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Per mITT Population(Up to Day 10 + 5 days)
- Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days(Up to Day 10 + 5 days)
- Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90(At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days)
- Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 35 + 6 Days(Up to Day 35 + 6 days)
- Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 10 + 5 Days(Up to Day 10 + 5 days)
- Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90(At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days)
- Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days(Up to Day 35 + 6 days)
- Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days(Up to Day 10 + 5 days)
- Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days(Up to Day 90 + 7 days)
- Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Intake of Any Study Medication (Day 35 + 6 Days)(Up to Day 35 + 6 days)
- Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Application of a Study Medication Syringe (Day 10 + 5 Days)(Up to Day 10 + 5 days)