Clinical trial NCT03088358: Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement
Official title: A Multicenter, Randomized, Pilot, Dose-Ranging Clinical Study to Evaluate Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Total Knee Replacement
Lead sponsor: TeaRx LLC
Sponsor class: INDUSTRY
First posted: 2017-03-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of deep venous thrombosis (DVT) (efficacy of the selected TeaRx dose)
timeFrame: 6 weeks following total knee replacement
measure: Incidence of nonfatal pulmonary embolism (PE) (efficacy of the selected TeaRx dose)
timeFrame: 6 weeks following total knee replacement
measure: Incidence of symptomatic venous thromboembolic events (DVT, PE) (efficacy of the selected TeaRx dose)
timeFrame: 6 weeks following total knee replacement
measure: venous thromboembolic events (VTE) caused mortality (efficacy of the selected TeaRx dose)
timeFrame: 6 weeks following total knee replacement
measure: Non-VTE caused mortality (efficacy of the selected TeaRx dose)
timeFrame: 6 weeks following total knee replacement
measure: AEs and SAEs from subject complaints, physical examination, vital signs, laboratory results (efficacy of the selected TeaRx dose)
timeFrame: 6 weeks following total knee replacement
Secondary outcomes:
measure: Incidence of bleeding (safety of selected TeaRx dose)
timeFrame: 6 weeks following total knee replacement
Other outcomes:
Locations:
city: Kazan
country: Russian Federation
facility: SHAI "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"
city: Moscow
country: Russian Federation
facility: Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation
city: Moscow
country: Russian Federation
facility: SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov Ministry of Health of the Russian Federation
city: Moscow
country: Russian Federation
facility: SHI of the city of Moscow City Clinical Hospital n.a. S.P. Botkin
city: Nizhny Novgorod
country: Russian Federation
facility: FSBI "Nizhny Novgorod Research Institute of Traumatology and Orthopedics" of the Ministry of Health of the Russian Federation
city: Orenburg
country: Russian Federation
facility: SBHI "City Clinical Hospital № 4" of the city of Orenburg
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Institution of Health "City Hospital № 2"
city: Yaroslavl
country: Russian Federation
facility: SHI of the Yaroslavl Region Emergency care hospital n. a. N. V. Solovyov
Study officials:
affiliation: Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation
name: Mikhail N. Zamyatin, Prof.
role: STUDY_CHAIR
References: