New blood clot pill could replace daily shots for joint replacement patients
NCT ID NCT07124819
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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215 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Jan 2025
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Bryansk City Hospital No. 1
Bryansk, Russia
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I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, Russia
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National Research Ogarev Mordovia State University
Saransk, Russia
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Privolzhsky Research Medical University
Nizhny Novgorod, Russia
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Rostov State Medical University
Rostov-on-Don, Russia
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Ryazan State Medical University named after academician I.P. Pavlov
Ryazan, Russia
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Samara Regional Clinical Hospital named after V.D. Seredavin
Samara, Russia
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Saratov State Medical University named after V. I. Razumovsky
Saratov, Russia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Which blood thinner is safer for lung clots? a Head-to-Head test
- Knee replacement pain: can a simple injection match a nerve block?
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- Which nerve block keeps you moving after knee surgery?
- Ultrasound may predict which patients get poor pain relief from a common knee block