Efficacy and Safety of Rivaroxaban Prophylaxis Compared With Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 841
- 主要终点
- Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components)
研究概览
简要总结
The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, superiority study comparing the efficacy and safety of rivaroxaban with placebo for primary prophylaxis of venous thromboembolism (VTE) in ambulatory adult participants, with various cancer types who are scheduled to initiate systemic cancer therapy. The study consists of 3 Phases: Screening Phase (14 Days), double-blind treatment Phase (180 Days) and follow up Phase (30 Days). The duration of participation in the study for each participant is approximately 32 weeks.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Have histologically confirmed solid malignancy including but not limited to: pancreas, lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (hematologic), with locally advanced or metastatic disease
- •Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- •Have a Khorana thromboembolic risk Score greater than or equal to (>=) 2
- •Creatinine clearance (CrCl) >= 30 milliliter per minute (mL/min)
- •Plan to initiate systemic cancer therapy within plus or minus (+-) 1 week of receiving the first dose of study drug with the intention of receiving systemic cancer therapy during the double-blind treatment period for an intended duration determined by the treating oncologist according to standard protocols of clinical care
排除标准
- •Diagnosis of primary brain tumors
- •Known history of brain metastases
- •Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a high risk for bleeding
- •Hematologic malignancies with the exception of lymphoma
- •Platelet count less than (<) 50,000/millimeter^3 (mm^3), Life expectancy of less than or equal to (<=) 6 months
研究组 & 干预措施
Placebo
Participants will be administered matching placebo tablet orally once daily for 180 days.
干预措施: Placebo (Drug)
Rivaroxaban
Participants will be administered rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components)
时间窗: Up to Day 180
Percentage of participants with time to the first occurrence of primary efficacy endpoint (composite and components) was reported. The primary efficacy composite endpoint is time to first occurrence of objectively confirmed symptomatic and asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE, or VTE-related death as adjudicated by an independent blinded Clinical Endpoint Committee (CEC).
Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH)
时间窗: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Major bleeding is defined as clinically overt bleeding that is associated with a reduction in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or occurrence at a critical site defined as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal, or fatal outcome.
次要结局
- Percentage of Participants With Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths(Up to Day 180)
- Percentage of Participants With All-Cause Mortality(Up to Day 180)
- Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE)(Up to Day 180)
- Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Visceral VTE(Up to Day 180)
- Percentage of Participants With Time to the First Occurrence of Composite Efficacy Endpoint 1(Up to Day 180)
- Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 2(Up to Day 180)
- Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 3(Up to Day 180)
- Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 4(Up to Day 180)
- Percentage of Participants With Time to the First Occurrence of Clinically Relevant Non-major Bleeding(From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks))
- Percentage of Participants With Time to the First Occurrence of Minor Bleeding(From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks))
- Percentage of Participants With Time to the First Occurrence of Any Bleeding(From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks))