drugset / Trial / NCT07124819

Dimolegin® (60 mg) Given Once Daily in Patients Undergoing Total Hip or Knee Replacement Compared to Enoxaparin

NCT07124819

Phase 3 Completed 215 enrolled Avexima Diol LLC
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This clinical study aims to evaluate the efficacy and safety of the anticoagulant Dimolegin® compared to low molecular weight heparin (Clexane®) for the prevention of venous thromboembolic events (VTE) in patients undergoing major joint (hip or knee) replacement surgery. The study will assess the incidence of VTE, VTE-related mortality, and all-cause mortality during different follow-up periods in both treatment groups. Additionally, the study will evaluate the frequency of bleeding events and the incidence, number, and characteristics of all adverse events associated with Dimolegin® and Clexane® therapy.

Timeline

Start
2024-07-22
Primary completion
2025-01-14
Completion
2025-01-14

Publications

  • Results Zagrekov VI, Usov AK, Vorontsov AK, Sapronova NG, Girkalo MV, Lychagin AV, Apartsin KA, Zolltukhin IA, Lomakin NV, Sychev DA. Efficacy and Safety of the Oral Anticoagulant DIMOLEGIN Compared to Enoxaparin Sodium for the Prevention of Venous Thromboembolism Following Major Joint Replacement Surgery (hip or knee arthroplasty): A Randomized, Double- Blind, Multicenter Trial. Russian Journal of Cardiology and Cardiovascular Surgery. 2025;18(5):577-585. (In Russ.). https://doi.org/10.17116/kardio202518051577

Drugs

EvaluationDrugModalityDoseRoute
Subject Dimolegin Unknown 60 mg
Comparator Enoxaparin sodium Other / unclassified Subcutaneous