AzTrials
AzTrials

Arthroplasty, Replacement, HipPhase 3NCT07124819

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

A Phase 3 study testing Sodium enoxaparin and Dimolegin in people with Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by Avexima Diol LLC at 8 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Sodium enoxaparin and Dimolegin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
215 participants
Where
8 sitesRussia
Study dates
22 Jul 2024to 14 Jan 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 30Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Russia8 sites

  • Bryansk City Hospital No. 1

    Bryansk

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

    Moscow

  • Privolzhsky Research Medical University

    Nizhny Novgorod

  • Rostov State Medical University

    Rostov-on-Don

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

    Ryazan

  • Samara Regional Clinical Hospital named after V.D. Seredavin

    Samara

  • National Research Ogarev Mordovia State University

    Saransk

  • Saratov State Medical University named after V. I. Razumovsky

    Saratov

Other trials in Russia

About this study

Official title: Randomized, Double-blind, Double-masked Prospective Multicenter Trial to Evaluate the Efficacy and Safety of the Oral Anticoagulant Dimolegin® Compared With Low Molecular Weight Heparin (Clexane®) as a Means of Preventing VTE in Patients Undergoing Elective Endoprosthetics of Large Joints

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.

Being tested
Sodium enoxaparin, Dimolegin, Dimolegin placebo, Sodium enoxaparine placebo
Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium enoxaparinDrug

    Also called Clexane

    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.

  • DimoleginDrug

    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.

  • Dimolegin placeboDrug

    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.

  • Sodium enoxaparine placeboDrug

    Also called Clexane 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.

Study groups in NCT07124819
Study groupRoleWhat they receive
1 (Dimolegin® Group)ExperimentalSubgroup 1A (Hip Arthroplasty): Dimolegin® + placebo Clexane® for 35±2 days. Subgroup 1B (Knee Arthroplasty): Dimolegin® + placebo Clexane® for 14±1 days.
Receives: Drug: Dimolegin; Drug: Sodium enoxaparine placebo
2 (Clexane® Group)Active comparatorSubgroup 2A (Hip Arthroplasty): Clexane® + placebo Dimolegin® for 35±2 days. Subgroup 2B (Knee Arthroplasty): Clexane® + placebo Dimolegin® for 14±1 days.
Receives: Drug: Sodium enoxaparin; Drug: Dimolegin placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (7)

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

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

  2. Switching to other anticoagulant therapy

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

  3. Incidence of DVT (proximal, distal)

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

  4. Incidence of non fatal PE

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

  5. Incidence of symptomatic VTE

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

  6. Death due to VTE

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

  7. Death of all causes

    Measured: up to the end of therapy (for subgroup A - up to 14±1 days, for subgroup B - up to 35±2 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2025
  2. Study start22 Jul 2024
  3. Primary completion14 Jan 2025
  4. Study completion14 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07124819
Sponsor's protocol ID
AVD-DIM-PН-2023-01
Status last verified
Jan 2026
First submitted
7 Aug 2025
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sodium enoxaparin and Dimolegin in people with Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by Avexima Diol LLC at 8 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite endpoint i.e.: confirmed symptomatic DVT, asymptomatic DVT, non fatal PE, death of all causes (time frame: up to the follow-up visit (28±2 days after the end of therapy)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07124819, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in