Dimolegin® (60 mg) Given Once Daily in Patients Undergoing Total Hip or Knee Replacement Compared… (NCT07124819) | Clinical Trial Compass
CompletedPhase 3
Dimolegin® (60 mg) Given Once Daily in Patients Undergoing Total Hip or Knee Replacement Compared to Enoxaparin
Russia215 participantsStarted 2024-07-22
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite endpoint i.e.: confirmed symptomatic DVT, asymptomatic DVT, non fatal PE, death of all causes
Timeframe: up to the follow-up visit (28±2 days after the end of therapy)