Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). A Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement.

RECORD 3 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled., Double-blind, Randomized Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00361894

Acronym

RECORD 3

Enrollment

2531

Registered

2006-08-09

Start date

2006-02-28

Completion date

2007-01-31

Last updated

2014-10-27

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

Conditions

Prevention, Venous Thromboembolism

Brief summary

The purpose of this study is to assess if 10 mg Bay 59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

Interventions

DRUGRivaroxaban (BAY59-7939)

10 mg rivaroxaban (tablet) once daily administered for 13 +/- 2 days

DRUGEnoxaparin

Syringe of enoxaparin at a dose of 40 mg for 13 +/- 2 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- Male and female patients aged 18 years or above- Patients scheduled for elective total knee replacement

Exclusion criteria

- Active bleeding or high risk of bleeding contraindicating treatment with LMWH- Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)- Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)

Design outcomes

Primary

Measure	Time frame
Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes	Treatment period: up to Day 13+/-4

Secondary

Measure	Time frame
Incidence of symptomatic VTE (DVT, PE)	Treatment period: up to Day 13+/-4
Incidence of DVT (total, proximal, distal)	Treatment period: up to Day 13+/-4
Incidence of symptomatic VTE during follow-up	Follow-up period: following 13+/-4 days
Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)	Treatment period: up to Day 13+/-4
Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death	Treatment period: up to Day 13+/-4
Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death	Treatment period: up to Day 13+/-4
Treatment-emergent major bleedings	From first dose of double-blind study medication to up to two days after last dose of double-blind study medication
The composite endpoint comprising major VTE and treatment-emergent major bleeding	For major VTE, treatment period: up to Day 13+/-4 ; for major bleeding, from first dose of double-blind study medication to up to two days after last dose of double-blind study medication

Countries

Austria, Belgium, Canada, China, Colombia, Czechia, Denmark, France, Germany, Israel, Italy, Mexico, Netherlands, Norway, Peru, Poland, South Africa, Spain, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026