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

NCT03088358 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-03-23

No results posted yet for this study

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

Conditions

  • Total Knee Replacement

Interventions

DRUG

TeaRx

DRUG

Enoxaparin

Sponsors & Collaborators

  • TeaRx LLC

    lead INDUSTRY

Principal Investigators

  • 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 Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03088358 on ClinicalTrials.gov