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To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TeaRx 50 mg | Experimental | TeaRx: 50 mg per day PO (active 25 mg + placebo 50 mg every 12 hours) during 12 days (±2 days) |
|
| TeaRx 100 mg | Experimental | TeaRx: 100 mg per day PO (placebo 25 mg + active 50 mg every 12 hours) during 12 days (±2 days) |
|
| TeaRx 150 mg | Experimental | TeaRx: 150 mg per day PO (active 25 mg + active 50 mg every 12 hours) during 12 days (±2 days) |
|
| Enoxaparin | Active Comparator | Enoxaparin 40 mg subcutaneous per day (24 hours interval) during 12 days (±2 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TeaRx | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of deep venous thrombosis (DVT) (efficacy of the selected TeaRx dose) | 6 weeks following total knee replacement | |
| Incidence of nonfatal pulmonary embolism (PE) (efficacy of the selected TeaRx dose) | 6 weeks following total knee replacement | |
| Incidence of symptomatic venous thromboembolic events (DVT, PE) (efficacy of the selected TeaRx dose) | 6 weeks following total knee replacement | |
| venous thromboembolic events (VTE) caused mortality (efficacy of the selected TeaRx dose) | 6 weeks following total knee replacement | |
| Non-VTE caused mortality (efficacy of the selected TeaRx dose) | 6 weeks following total knee replacement | |
| AEs and SAEs from subject complaints, physical examination, vital signs, laboratory results (efficacy of the selected TeaRx dose) | 6 weeks following total knee replacement |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of bleeding (safety of selected TeaRx dose) | major and clinically relevant non-major bleeding | 6 weeks following total knee replacement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikhail N. Zamyatin, Prof. | Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SHAI "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan" | Kazan' | 420064 | Russia | |||
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| Enoxaparin |
| Drug |
|
|
| Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation |
| Moscow |
| 105203 |
| Russia |
| SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov Ministry of Health of the Russian Federation | Moscow | 119435 | Russia |
| SHI of the city of Moscow City Clinical Hospital n.a. S.P. Botkin | Moscow | 125284 | Russia |
| FSBI "Nizhny Novgorod Research Institute of Traumatology and Orthopedics" of the Ministry of Health of the Russian Federation | Nizhny Novgorod | 603155 | Russia |
| SBHI "City Clinical Hospital № 4" of the city of Orenburg | Orenburg | 460000 | Russia |
| St. Petersburg State Institution of Health "City Hospital № 2" | Saint Petersburg | 194354 | Russia |
| SHI of the Yaroslavl Region Emergency care hospital n. a. N. V. Solovyov | Yaroslavl | 150003 | Russia |
| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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