CompletedPhase 3

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

Russia215 participantsStarted 2024-07-22

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women between the ages of 18 and 80. * Patients scheduled for unilateral elective total hip or knee arthroplasty. * The patient's voluntary informed consent. * Negative pregnancy test result (for female patients with preserved reproductive potential). * Patients with reproductive potential should agree to use methods of contraception according to the protocol. Exclusion Criteria: * Surgery for an acute fracture (\<4 weeks). * Revision or extraction arthroplasty. * Septic arthritis. * The only lower limb. * Increased risk of thrombosis. * Active bleeding or increased risk of bleeding. * Current coagulopathy (patient's or his relative's) or congenital thrombophilia. * Collection of at least one volume unit of donated blood (≥ 450 ml) or blood transfusion during the previous 12 weeks. * Surgery or injury during the last 90 days. * Diseases of the digestive system that may disrupt the absorption of the study drug. * Significant cardiovascular diseases currently or within 6 months prior to screening. * Active liver or biliary tract diseases. * Creatinine clearance, calculated according to the Cockcroft-Gault formula, less than 30 ml/min. * Positive test result for HIV, syphilis, hepatitis B and C markers. * The development of trophic disorders of the lower extremities that are not amenable to drug treatment. * Any condition in which, in the opinion of the researcher, surgical intervention or the use of anticoagulants is contraindicated. * Body mass…

What they're measuring

Composite endpoint i.e.: confirmed symptomatic DVT, asymptomatic DVT, non fatal PE, death of all causes

Timeframe: up to the follow-up visit (28±2 days after the end of therapy)

Trial details

NCT IDNCT07124819

SponsorAvexima Diol LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-14