SHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty

Beijing Suncadia Pharmaceuticals Co., Ltd353 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

353

Conditions

Prevention of Venous Thromboembolism After Knee Arthroplasty

Interventions

SHR-2004 injectionDRUG

low dose subcutaneous injection once

SHR-2004 injectionDRUG

medium dose subcutaneous injection once

SHR-2004 injectionDRUG

high dose subcutaneous injection once

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Xiangya Hospital Central South University

Changsha, Hunan, China

Outcomes

Primary Outcomes

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）

Time frame: Day 12

Incidence of composite endpoint of major and clinically relevant non-major bleeding（Primary safety outcome）

Time frame: Day 12

Secondary Outcomes

Time frame: Day 85

Incidence of composite endpoint of any bleeding（Secondary safety endpoint）

Time frame: Day 12

Incidence of composite endpoint of major and clinically relevant non-major bleeding（Secondary safety endpoint）

Time frame: Day 85

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.