Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement
- Registration Number
- NCT03088358
- Lead Sponsor
- TeaRx LLC
- Brief Summary
To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group:
* Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality
* Incidence of DVT (total, proximal, distal)
* Incidence of nonfatal PE
* Incidence of symptomatic VTE (DVT, PE)
* VTE caused mortality
* Non-VTE caused mortality
* Incidence of all hemorrhagic complications
* Incidence of major and clinically relevant non-major bleeding
* Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical examination, vital signs, laboratory results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Male or female, age ≥ 18 years;
- Planned total knee replacement surgery;
- Signed informed consent form;
- Willing to comply with the protocol;
- Willing to use adequate contraception during the trial.
- Surgery for acute fracture 4 weeks before screening; history of septic inflammation in the joint; prosthesis revision or one leg missing
- History of venous thrombosis of any location or PE
- History of heparin induced thrombocytopenia or other thrombocytopathy; hemorrhagic diathesis
- History of evident coagulopathy or in a relative
- Congenital thrombophilia
- Bleeding within 6 months of screening; increased risk of bleeding
- BMI less than 18,5 or more than 40 kg/m2
- Systolic BP > 180 mmHg and/or diastolic BP > 110 mmHg registered twice within 15-30 minutes
- Hb ≤ 10.5 g/dL in female or ≤ 11.5 g/dL in male
- Platelets < 100 000/mm3
- Clinical significant abnormalities of APTT and/or INR
- GFR < 30 ml/min/1.73 m2
- ALT or AST ≥ 2 x ULN or total bilirubin ≥1,5 x ULN
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TeaRx 50 mg TeaRx TeaRx: 50 mg per day PO (active 25 mg + placebo 50 mg every 12 hours) during 12 days (±2 days) TeaRx 100 mg TeaRx TeaRx: 100 mg per day PO (placebo 25 mg + active 50 mg every 12 hours) during 12 days (±2 days) TeaRx 150 mg TeaRx TeaRx: 150 mg per day PO (active 25 mg + active 50 mg every 12 hours) during 12 days (±2 days) Enoxaparin Enoxaparin Enoxaparin 40 mg subcutaneous per day (24 hours interval) during 12 days (±2 days)
- Primary Outcome Measures
Name Time Method venous thromboembolic events (VTE) caused mortality (efficacy of the selected TeaRx dose) 6 weeks following total knee replacement 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 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
- Secondary Outcome Measures
Name Time Method Incidence of bleeding (safety of selected TeaRx dose) 6 weeks following total knee replacement major and clinically relevant non-major bleeding
Trial Locations
- Locations (8)
St. Petersburg State Institution of Health "City Hospital № 2"
🇷🇺Saint Petersburg, Russian Federation
SHI of the city of Moscow City Clinical Hospital n.a. S.P. Botkin
🇷🇺Moscow, Russian Federation
SHAI "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"
🇷🇺Kazan, Russian Federation
Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation
🇷🇺Moscow, Russian Federation
FSBI "Nizhny Novgorod Research Institute of Traumatology and Orthopedics" of the Ministry of Health of the Russian Federation
🇷🇺Nizhny Novgorod, Russian Federation
SBHI "City Clinical Hospital № 4" of the city of Orenburg
🇷🇺Orenburg, Russian Federation
SHI of the Yaroslavl Region Emergency care hospital n. a. N. V. Solovyov
🇷🇺Yaroslavl, Russian Federation
SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov Ministry of Health of the Russian Federation
🇷🇺Moscow, Russian Federation