Prevention of Venous Thromboembolism After Knee Arthroplasty
Conditions
Brief summary
The purpose of the study is to evaluate the efficacy and safety of SHR-2004 in preventing venous thromboembolism after elective unilateral total knee arthroplasty
Interventions
low dose subcutaneous injection once
40 mg administered as subcutaneous injection once daily
Sponsors
Beijing Suncadia Pharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
SHR-2004 injection compared with Enoxaparin sodium injection
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Understand the research procedures and methods, volunteer to participate in the study, and sign the informed consent 2. Scheduled to undergo elective unilateral total knee arthroplayts (TKA) 3. Male or female(≥ 40 years old and \< 80 years old)
Exclusion criteria
1. Unable to receive CT angiography of both lower limbs; 2. Malignant tumor within one year of the screening ; 3. History of venous thromboembolism; 4. Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening; 5. Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding 6. Any of the laboratory test indicators meets the following criteria: ①estimated Glomerular Filtration Rate \< 60 mL/min/1.73m2 ; ②Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times the upper limit of normal value (ULN); ③total bilirubin was \> 2 times, etc 7. History of drug abuse; 8. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral CT venography, confirmed symptomatic DVT, non-fatal PE and all-cause death（Primary efficacy outcome） | Day 12 |
| Incidence of composite endpoint of major and clinically relevant non-major bleeding（Primary safety outcome） | Day 12 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral CT venography, confirmed symptomatic DVT, non-fatal PE and all-cause death（Secondary efficacy endpoint） | Day 85 |
| Incidence of composite endpoint of any bleeding（Secondary safety endpoint） | Day 12 |
| Incidence of composite endpoint of major and clinically relevant non-major bleeding（Secondary safety endpoint） | Day 85 |
Countries
China
Outcome results
None listed