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Sequential Rivaroxaban Versus Aspirin for Venous Thromboembolism Prevention After Total Hip/Knee Arthroplasty in High-Risk Patients: A multicenter, prospective, randomized controlled trial (SEQUENCE-VTE)

Sequential Rivaroxaban Versus Aspirin for Venous Thromboembolism Prevention After Total Hip/Knee Arthroplasty in High-Risk Patients: A multicenter, prospective, randomized controlled trial (SEQUENCE-VTE)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120507
Enrollment
Unknown
Registered
2026-03-16
Start date
2026-04-07
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous thrombosis

Interventions

Low-molecular-weight heparin followed by rivaroxaban:During the hospitalization, standardized heparin treatment was administered. After discharge, rivaroxaban 10 mg was taken orally once daily. The tr
The low-molecular-weight heparin followed by aspirin group:During the hospitalization, standardized heparin treatment was given. After discharge, aspirin 100 mg was taken orally once a day. Treatment

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age>= 18 years, planned for THA or TKA; (2) Preoperatively, assessed by Caprini score as having a high VTE risk (>= 8 points); (3) Expected to be able to take oral medications after surgery and complete at least 90-day follow-up; (4) The subject voluntarily participates in the study and signs a written informed consent form.

Exclusion criteria

Exclusion criteria: (1) Active bleeding or high-risk bleeding status; (2) Abnormal coagulation function (such as platelet count 5 times the upper limit of normal value); (4) Severe renal insufficiency (estimated glomerular filtration rate < 30 mL/min, or in a state of kidney transplantation/hemodialysis); (5) Pregnancy or lactation period; (6) Allergic to the study drug (rivaroxaban/aspirin) or having clear contraindications (such as active gastrointestinal ulcer, etc.); (7) Expected survival period < 1 year; (8) Active tumor requiring systemic treatment or recent chemotherapy/radiotherapy; (9) Presence of serious neurological diseases that are unsuitable for surgery or unable to complete follow-up; (10) History of hip/leg fracture within the past 3 months; (11) Recent major surgery within the past 3 months; (12) Long-term anticoagulant therapy due to other comorbidities; (13) Concurrent use of drugs that strongly inhibit or induce P-gp and CYP3A4; (14) Concurrent participation in other interventional clinical trials; (15) Members of the research team or their immediate family members.

Design outcomes

Primary

MeasureTime frame
Symptomatic deep vein thrombosis;Symptomatic pulmonary embolism;Bleeding incident;

Secondary

MeasureTime frame
all-cause mortality;Unplanned readmission;Surgical-related complications;Arterial embolism event;Drug-related adverse reactions;

Countries

China

Contacts

Public ContactQiming Liu

The Second Xiangya Hospital of Central South University

qimingliu@csu.edu.cn+86 138 7318 1753

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026