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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 (Dimolegin® Group) | Experimental | 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) | Active Comparator | Subgroup 2A (Hip Arthroplasty): Clexane® + placebo Dimolegin® for 35±2 days. Subgroup 2B (Knee Arthroplasty): Clexane® + placebo Dimolegin® for 14±1 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium enoxaparin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bryansk City Hospital No. 1 | Bryansk | Russia | ||||
| I.M. Sechenov First Moscow State Medical University (Sechenov University) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
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|
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| Dimolegin | Drug | 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 placebo | Drug | 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 placebo | Drug | 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. |
|
|
| 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) |
| Moscow |
| 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 |
| National Research Ogarev Mordovia State University | Saransk | Russia |
| Saratov State Medical University named after V. I. Razumovsky | Saratov | Russia |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000711671 | enoxaparin sodium |
| D017984 | Enoxaparin |
| C000721990 | (+-)-(1'R*,2'S*,6'R*)-(2-hydroxy-4,6-dimethoxyphenyl)(3'-methyl-2'-(3''-methylbut-2''-enyl)-6-phenylcyclohex-3'-enyl)methanone |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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