Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

RECORD 2 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Hip Replacement.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00332020

Acronym

RECORD 2

Enrollment

2457

Registered

2006-05-31

Start date

2006-02-28

Completion date

2007-06-30

Last updated

2015-01-27

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 can help prevent blood clots forming after a hip replacement operation.

Interventions

DRUGRivaroxaban (BAY59-7939)

10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days

DRUGEnoxaparin

40 mg enoxaparin syringe administered for 12 +/- 2 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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 hip replacement

Exclusion criteria

* Planned, staged total bilateral hip replacement * Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin * Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin * Conditions prohibiting bilateral venography (e.g. amputation of one 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 35+/-6

Secondary

Measure	Time frame
Incidence of symptomatic VTE (DVT, PE)	Treatment period: up to day 35+/-6
Incidence of DVT (total, proximal, distal)	Treatment period: up to day 35+/-6
Incidence of symptomatic VTE during follow-up	Follow-up period: following 35+/-6 days
Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)	Treatment period: up to day 35+/-6
Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death	Treatment period: up to day 35+/-6
Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death	Treatment period: up to day 35+/-6
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 35+/-6 ; 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

Australia, Brazil, Canada, China, Colombia, Denmark, Estonia, India, Indonesia, Italy, Latvia, Lithuania, Mexico, New Zealand, Norway, Peru, Portugal, South Africa, South Korea, Sweden, Taiwan, United Kingdom, United States

Outcome results

None listed

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