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

Not Applicable

Completed

• Conditions: Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Venous Thromboembolism (VTE); Prevention
• Interventions: Drug: Dimolegin; Drug: Sodium enoxaparin; Drug: Sodium enoxaparine placebo; Drug: Dimolegin placebo

• Registration Number: NCT07124819
• Lead Sponsor: Avexima Diol LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-22
• Primary Completion: 2025-01-14
• Study Completion: 2025-01-14
• Status Verified: 2025-08
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 (Dimolegin® Group)	Dimolegin	Subgroup 1A (Hip Arthroplasty): Dimolegin® + placebo Clexane® for 35±2 days. Subgroup 1B (Knee Arthroplasty): Dimolegin® + placebo Clexane® for 14±1 days.
1 (Dimolegin® Group)	Sodium enoxaparine placebo	Subgroup 1A (Hip Arthroplasty): Dimolegin® + placebo Clexane® for 35±2 days. Subgroup 1B (Knee Arthroplasty): Dimolegin® + placebo Clexane® for 14±1 days.
2 (Clexane® Group)	Sodium enoxaparin	Subgroup 2A (Hip Arthroplasty): Clexane® + placebo Dimolegin® for 35±2 days. Subgroup 2B (Knee Arthroplasty): Clexane® + placebo Dimolegin® for 14±1 days.
2 (Clexane® Group)	Dimolegin placebo	Subgroup 2A (Hip Arthroplasty): Clexane® + placebo Dimolegin® for 35±2 days. Subgroup 2B (Knee Arthroplasty): Clexane® + placebo Dimolegin® for 14±1 days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Death due to VTE	up to the follow-up visit (28±2 days after the end of therapy)
Death of all causes	up to the end of therapy (for subgroup A - up to 14±1 days, for subgroup B - up to 35±2 days)

Trial Locations

Locations (8)

Bryansk City Hospital No. 1; 🇷🇺 Bryansk, Russian Federation

I.M. Sechenov First Moscow State Medical University (Sechenov University); 🇷🇺 Moscow, Russian Federation

Privolzhsky Research Medical University; 🇷🇺 Nizhny Novgorod, Russian Federation

Rostov State Medical University; 🇷🇺 Rostov-on-Don, Russian Federation

Ryazan State Medical University named after academician I.P. Pavlov; 🇷🇺 Ryazan', Russian Federation

Samara Regional Clinical Hospital named after V.D. Seredavin; 🇷🇺 Samara, Russian Federation

National Research Ogarev Mordovia State University; 🇷🇺 Saransk, Russian Federation

Saratov State Medical University named after V. I. Razumovsky; 🇷🇺 Saratov, Russian Federation