Clinical Study on the Efficacy and Safety of Multiple Oral Administrations of SHR2285 Tablets in Patients Undergoing Elective Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prevention of Venous Thrombosis After TKA

Intervention / Treatment
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* Drug: SHR2285 tablet
* Drug: SHR2285 tablet
* Drug: SHR2285 tablet
* Drug: SHR2285 tablet
* Drug: Enoxaparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: SHR2285 tablets compared with Enoxaparin
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group 1<br>SHR2285 tablet; dose 1 | Drug: SHR2285 tablet<br>* SHR2285 tablet; dose 1, for 12 days<br>|
| Experimental: Treatment group 2<br>SHR2285 tablet; dose 2 | Drug: SHR2285 tablet<br>* SHR2285 tablet; dose 2, for 12 days<br>|
| Experimental: Treatment group 3<br>SHR2285 tablet; dose 3 | Drug: SHR2285 tablet<br>* SHR2285 tablet; dose 3, for 12 days<br>|
| Experimental: Treatment group 4<br>SHR2285 tablet; dose 4 | Drug: SHR2285 tablet<br>* SHR2285 tablet; dose 4, for 12 days<br>|
| Active Comparator: Treatment group 5<br>Enoxaparin | Drug: Enoxaparin<br>* Enoxaparin, for 12 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with confirmed composite endpoint | 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 | Day 12 | 
| Number of patients with composite bleeding | Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events | Day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with composite venous thromboembolic events (VTE) | Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic/non-symptomatic venous thromboembolic events (VTE), non-fatal pulmonary embolism (PE) ,all-cause deaths | Day 1 to Day 12 | 
| Number of patients with composite venous thromboembolic events (VTE) | Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic/non-symptomatic venous thromboembolic events (VTE), non-fatal pulmonary embolism (PE) ,all-cause deaths | Day 1 to Day 42 |