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

NCT ID: NCT07124819

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-22
• Study Completion Date: 2025-01-14

Brief 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.

Conditions

Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Venous Thromboembolism (VTE); Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1 (Dimolegin® Group)

Subgroup 1A (Hip Arthroplasty): Dimolegin® + placebo Clexane® for 35±2 days. Subgroup 1B (Knee Arthroplasty): Dimolegin® + placebo Clexane® for 14±1 days.

Group Type: EXPERIMENTAL

Dimolegin

Intervention Type: DRUG

Subgroup 1A (Hip Arthroplasty): Patients undergoing total hip arthroplasty will receive Dimolegin® starting 6-10 hours after surgery everyday for 35±2 days.

Subgroup 1B (Knee Arthroplasty): Patients undergoing total knee arthroplasty will receive Dimolegin® starting 6-10 hours after surgery everyday for 14±1 days.

Sodium enoxaparine placebo

Intervention Type: DRUG

Subgroup 1A (Hip Arthroplasty): Patients undergoing total hip arthroplasty will receive palcebo Clexane® subcutaneously administered 12±1 hours before surgery starting 6-10 hours after surgery everyday for 35±2 days.

Subgroup 2B (Knee Arthroplasty): Patients undergoing total knee arthroplasty will receive placebo Clexane® subcutaneously administered 12±1 hours before surgery everyday for 14±1 days.

2 (Clexane® Group)

Subgroup 2A (Hip Arthroplasty): Clexane® + placebo Dimolegin® for 35±2 days. Subgroup 2B (Knee Arthroplasty): Clexane® + placebo Dimolegin® for 14±1 days.

Group Type: ACTIVE_COMPARATOR

Sodium enoxaparin

Intervention Type: DRUG

Subgroup 2A (Hip Arthroplasty): Patients undergoing total hip arthroplasty will receive Clexane® subcutaneously administered 12±1 hours before surgery starting 6-10 hours after surgery everyday for 35±2 days.

Subgroup 2B (Knee Arthroplasty): Patients undergoing total knee arthroplasty will receive Clexane® subcutaneously administered 12±1 hours before surgery everyday for 14±1 days.

Dimolegin placebo

Intervention Type: DRUG

Subgroup 2A (Hip Arthroplasty): Patients undergoing total hip arthroplasty will receive placebo Dimolegin® starting 6-10 hours after surgery everyday for 35±2 days. Subgroup 2B (Knee Arthroplasty): Patients undergoing total knee arthroplasty will receive placebo Dimolegin® starting 6-10 hours after surgery everyday for 14±1 days.

Interventions

Sodium enoxaparin

Subgroup 2A (Hip Arthroplasty): Patients undergoing total hip arthroplasty will receive Clexane® subcutaneously administered 12±1 hours before surgery starting 6-10 hours after surgery everyday for 35±2 days.

Subgroup 2B (Knee Arthroplasty): Patients undergoing total knee arthroplasty will receive Clexane® subcutaneously administered 12±1 hours before surgery everyday for 14±1 days.

Intervention Type: DRUG

Dimolegin

Subgroup 1A (Hip Arthroplasty): Patients undergoing total hip arthroplasty will receive Dimolegin® starting 6-10 hours after surgery everyday for 35±2 days.

Subgroup 1B (Knee Arthroplasty): Patients undergoing total knee arthroplasty will receive Dimolegin® starting 6-10 hours after surgery everyday for 14±1 days.

Intervention Type: DRUG

Dimolegin placebo

Subgroup 2A (Hip Arthroplasty): Patients undergoing total hip arthroplasty will receive placebo Dimolegin® starting 6-10 hours after surgery everyday for 35±2 days. Subgroup 2B (Knee Arthroplasty): Patients undergoing total knee arthroplasty will receive placebo Dimolegin® starting 6-10 hours after surgery everyday for 14±1 days.

Intervention Type: DRUG

Sodium enoxaparine placebo

Subgroup 1A (Hip Arthroplasty): Patients undergoing total hip arthroplasty will receive palcebo Clexane® subcutaneously administered 12±1 hours before surgery starting 6-10 hours after surgery everyday for 35±2 days.

Subgroup 2B (Knee Arthroplasty): Patients undergoing total knee arthroplasty will receive placebo Clexane® subcutaneously administered 12±1 hours before surgery everyday for 14±1 days.

Intervention Type: DRUG

Other Intervention Names

Clexane; Clexane placebo

Eligibility Criteria

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 index is less than 18.5 or more than 40 kg/m2.
• Body weight for women is less than 45 kg, for men less than 57 kg and above 130 kg for both.
• Systolic blood pressure > 180 mmHg and/or diastolic blood pressure >110 mmHg.
• Hemoglobin < 105 g/l in women or < 115 g/l in men.
• Abnormal results aboratory parameters of the coagulation system (platelets, APTT, prothrombin time, INR) beyond the limits of normal values.
• An increase in ALT or ACT ≥ 2 times from the upper limit of normal (ULN) or total bilirubin ≥ 1.5 times from ULN.
• Hypersensitivity or contraindications to the administration of Dimolegin®, enoxaparin sodium, unfractionated heparin or warfarin.
• The need for constant use of parenteral or oral anticoagulants.
• The need for continuous use of antiplatelet drugs, which cannot be discontinued at least 4 days before the start of the investigational therapy.
• Systemic therapy with drugs with strong inducers and inhibitors of CYP3A4 and P-glycoprotein, which cannot be discontinued at least 7 days before the start of the investigational therapy.
• Pregnant or breast-feeding women.
• Participation in another clinical trial currently or within 90 days prior to screening.
• Affiliation to a research center, Sponsor, or contractual research organization.
• Inability to read or write; unwillingness to understand and follow the procedures of the study protocol; non-compliance with the study therapy or procedures.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avexima Diol LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bryansk City Hospital No. 1

Bryansk, , Russia

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, , Russia

Privolzhsky Research Medical University

Nizhny Novgorod, , Russia

Rostov State Medical University

Rostov-on-Don, , Russia

Ryazan State Medical University named after academician I.P. Pavlov

Ryazan, , Russia

Samara Regional Clinical Hospital named after V.D. Seredavin

Samara, , Russia

National Research Ogarev Mordovia State University

Saransk, , Russia

Saratov State Medical University named after V. I. Razumovsky

Saratov, , Russia

Countries

Russia

References

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

Reference Type: RESULT

Other Identifiers

AVD-DIM-PН-2023-01

Identifier Type: -

Identifier Source: org_study_id