Clinical trial NCT05752461: SHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
Official title: A Multicenter, Randomized, Active-comparator-controlled Phase 2 Clinical Trial to Assess the Efficacy and Safety of a Single Subcutaneous Injection of SHR-2004 in Patients Undergoing Elective Unilateral Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prevention of Venous Thromboembolism After Knee Arthroplasty
Lead sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-03-02
Enrollment: 353
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR-2004 injection compared with Enoxaparin sodium injection
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: 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）
timeFrame: Day 12
measure: Incidence of composite endpoint of major and clinically relevant non-major bleeding（Primary safety outcome）
timeFrame: Day 12
Secondary outcomes:
measure: 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）
timeFrame: Day 85
measure: Incidence of composite endpoint of any bleeding（Secondary safety endpoint）
timeFrame: Day 12
measure: Incidence of composite endpoint of major and clinically relevant non-major bleeding（Secondary safety endpoint）
timeFrame: Day 85
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
Study officials:
References: