Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03088358

Enrollment

200

Registered

2017-03-23

Start date

2013-08-31

Completion date

2015-09-30

Last updated

2017-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Replacement

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

Interventions

DRUGTeaRx

DRUGEnoxaparin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of symptomatic venous thromboembolic events (DVT, PE) (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
AEs and SAEs from subject complaints, physical examination, vital signs, laboratory results (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

Secondary

Measure	Time frame	Description
Incidence of bleeding (safety of selected TeaRx dose)	6 weeks following total knee replacement	major and clinically relevant non-major bleeding

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026