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New blood clot pill could replace daily shots for joint replacement patients

NCT ID NCT07124819

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study compared an experimental oral anticoagulant called Dimolegin to the standard injectable drug Clexane for preventing venous thromboembolism (VTE) in 215 adults undergoing hip or knee replacement surgery. The goal was to see if the pill is as effective and safe as the injection in reducing blood clots, clot-related deaths, and bleeding events. If successful, Dimolegin could offer a more convenient, needle-free option for post-surgery clot prevention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dimolegin (oral anticoagulant)
What this could lead to
If it works, this could offer a convenient pill alternative to daily injections for preventing dangerous blood clots after joint replacement surgery.
What could go wrong
This is a completed phase 3 trial with 215 participants, but results are not yet published. The new drug may not be as effective or safe as the standard treatment, and bleeding risks are a concern.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

215 people

The number who actually took part.

Started

Jul 2024

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Bryansk City Hospital No. 1

    Bryansk, Russia

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

    Moscow, Russia

  • National Research Ogarev Mordovia State University

    Saransk, 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

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

    Saratov, Russia

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