Preventing blood clots after knee surgery with SHR-2004 injection
Multicenter, Randomized, Double-blind, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Arthroplasty
This study is testing if an injection called SHR-2004 can help prevent blood clots in people who are having knee surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1167 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Beijing Suncadia Pharmaceuticals Co., Ltd Industry-sponsored |
| Locations | 2 sites (Beijing, Beijing and 1 other locations) |
| Trial ID | NCT06825416 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of SHR-2004 injection in preventing venous thromboembolism in patients undergoing elective unilateral total knee arthroplasty. Participants will receive either SHR-2004, Enoxaparin sodium, or placebos to compare outcomes. The study aims to determine if SHR-2004 can reduce the incidence of blood clots following surgery. It involves a Phase III interventional approach to assess the drug's performance in a controlled setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 scheduled for elective total knee arthroplasty.
Not a fit: Patients with a recent history of bleeding risks or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of venous thromboembolism in knee surgery patients.
How similar studies have performed: Other studies have shown success with similar anticoagulant approaches, indicating potential for SHR-2004.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing and 1 other locations
- Fourth Medical Center of Chinese People's Liberation Army General Hospital — Beijing, Beijing, China (Recruiting)
- Xiangya Hospital, Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Zhuang Nie
- Email: zhuang.nie@hengrui.com
- Phone: +86-0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.