Efficacy and Safety of SHR2285 Tablets Following Multiple Oral Administrations in Patients Undergoing Elective Total Knee Arthroplasty: a Multicenter, Randomized, Positive-controlled Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Number of patients with confirmed composite endpoint
研究概览
简要总结
This study is a multi-center, randomized, open-label, double-blind, positive-controlled phase II clinical study evaluating the efficacy and safety of different doses of SHR2285 tablets vs. enoxaparin for the prevention of postoperative venous thromboembolism in patients undergoing elective unilateral total knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand the study procedures and methods, voluntarily participate in the study, and sign the written informed consent form (ICF);
- •Scheduled to undergo elective unilateral total knee arthroplasty;
- •Males or females aged 40-75 years.
排除标准
- •Weighing less than 40 kg or greater than 135 kg;
- •Allergic to contrast agents rendering the patient unable to undergo venous angiography of the lower extremities; allergic to enoxaparin or any of the ingredients listed in the package insert thereof; allergic to the investigational product or any of the ingredients thereof;
- •With malignant tumors that still require medical intervention; except for radically treated non-melanoma skin cancer, basal cell carcinoma or squamous cell skin cancer, or cervical carcinoma in situ;
- •With a history of major liver disease within 1 year;
- •With myocardial infarction, transient ischemic attack, or ischemic stroke within 6 months.
研究组 & 干预措施
Treatment group 5
Enoxaparin
干预措施: Enoxaparin (Drug)
Treatment group 1
SHR2285 tablet; dose 1
干预措施: SHR2285 tablet (Drug)
Treatment group 2
SHR2285 tablet; dose 2
干预措施: SHR2285 tablet (Drug)
Treatment group 3
SHR2285 tablet; dose 3
干预措施: SHR2285 tablet (Drug)
Treatment group 4
SHR2285 tablet; dose 4
干预措施: SHR2285 tablet (Drug)
结局指标
主要结局
Number of patients with confirmed composite endpoint
时间窗: Day 12
Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic/non-symptomatic venous thromboembolic events (VTE), non-fatal pulmonary embolism (PE) or all-cause deaths
Number of patients with composite bleeding
时间窗: Day 12
Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events
次要结局
- Number of patients with composite venous thromboembolic events (VTE)(Day 1 to Day 42)