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FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty

NCT03276143 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 813

Last updated 2020-03-03

No results posted yet for this study

Summary

This study was to compare the study drug BAY1213790 to existing therapies, i.e. enoxaparin or apixaban, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA). The study was open-label, but observer-blinded for the different doses of BAY1213790. This means that it was known which treatment was given, but it was not known which dose of BAY1213790 was administered.

Conditions

  • Knee Arthroplasty, Total

Interventions

DRUG

Enoxaparin

40 mg enoxaparin administered as subcutaneous injection once daily

DRUG

Apixaban

2.5 mg apixaban administered as tablet orally twice daily

DRUG

BAY1213790

Single dose of BAY1213790 administered as intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-21
Primary Completion
2018-08-20
Completion
2019-01-02

Countries

  • Bulgaria
  • Canada
  • Czechia
  • Greece
  • Israel
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Russia
  • South Africa
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

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 NCT03276143 on ClinicalTrials.gov