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

NCT07124819 | Completed Phase 3 DMC

• 1 other identifier: AVD-DIM-PН-2023-01
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 8

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

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (7)

• Composite endpoint i.e.: confirmed symptomatic DVT, asymptomatic DVT, non fatal PE, death due to thrombosis

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

• Switching to other anticoagulant therapy

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

• Incidence of DVT (proximal, distal)

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

• Incidence of non fatal PE

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

• Incidence of symptomatic VTE

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

Study Arms (2)

1 (Dimolegin® Group)

EXPERIMENTAL

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

Drug: Dimolegin; Drug: Sodium enoxaparine placebo

2 (Clexane® Group)

ACTIVE COMPARATOR

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

Drug: Sodium enoxaparin; Drug: Dimolegin placebo

Interventions

Sodium enoxaparin 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.

Also known as: Clexane

2 (Clexane® Group)

Dimolegin 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.

1 (Dimolegin® Group)

Dimolegin placebo 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.

2 (Clexane® Group)

Sodium enoxaparine placebo 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.

Also known as: Clexane placebo

1 (Dimolegin® Group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avexima Diol LLC: lead

Study Sites (8)

Bryansk City Hospital No. 1

Bryansk, Russia

Location

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

Moscow, Russia

Location

Privolzhsky Research Medical University

Nizhny Novgorod, Russia

Location

Rostov State Medical University

Rostov-on-Don, Russia

Location

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

Ryazan, Russia

Location

Samara Regional Clinical Hospital named after V.D. Seredavin

Samara, Russia

Location

National Research Ogarev Mordovia State University

Saransk, Russia

Location

Saratov State Medical University named after V. I. Razumovsky

Saratov, Russia

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

enoxaparin sodium; Enoxaparin; (+-)-(1'R*,2'S*,6'R*)-(2-hydroxy-4,6-dimethoxyphenyl)(3'-methyl-2'-(3''-methylbut-2''-enyl)-6-phenylcyclohex-3'-enyl)methanone

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 15, 2025
• Study Start: July 22, 2024
• Primary Completion: January 14, 2025
• Study Completion: January 14, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (8)