CompletedPhase 3

A Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty

China1,166 participantsStarted 2025-03-16

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Understand the research procedures and methods, volunteer to participate in this trial, and sign the informed consent form in writing;
✓. Planned elective schedule total knee arthroplasty (TKA) patients;
✓. Men or women who are ≥ 18 years old and \< 80 years old on the day of signing the informed consent form.

Exclusion criteria

✕. Unable to receive CT angiography of both lower limbs;
✕. Malignant tumor within one year of the screening;
✕. Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening;
✕. Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding;
✕. History of drug abuse;
✕. Pregnant or lactating women.

What they're measuring

Incidence of asymptomatic deep vein thrombosis (DVT)

Timeframe: Day 12.

Incidence of non-fatal pulmonary embolism (PE)

Timeframe: Day 12.

Trial details

NCT IDNCT06825416

SponsorBeijing Suncadia Pharmaceuticals Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-15

View on ClinicalTrials.gov More Prevention of Arterial and Venous Thrombosis trials