Prevention of Arterial and Venous Thrombosis
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
SHR-2004 injection in low dose.
Enoxaparin sodium injection.
DRUGEnoxaparin sodium injection placebo
Enoxaparin sodium injection placebo.
DRUGSHR-2004 placebo
SHR-2004 placebo in low dose.
Sponsors
Beijing Suncadia Pharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Understand the research procedures and methods, volunteer to participate in this trial, and sign the informed consent form in writing; 2. Planned elective schedule total knee arthroplasty (TKA) patients; 3. Men or women who are ≥ 18 years old and \< 80 years old on the day of signing the informed consent form.
Exclusion criteria
1. Unable to receive CT angiography of both lower limbs; 2. Malignant tumor within one year of the screening; 3. Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening; 4. Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding; 5. History of drug abuse; 6. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of asymptomatic deep vein thrombosis (DVT) | Day 12. |
| Incidence of non-fatal pulmonary embolism (PE) | Day 12. |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) | Day 65. |
| Bleeding events | Day 12. |
Countries
China
Outcome results
None listed