Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism DVT and Pulmonary Embolism (PE); a Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00362232

Purpose

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.

Condition	Intervention	Phase
Venous Thromboembolism	Drug: Rivaroxaban (BAY59-7939) Drug: Enoxaparin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	RECORD 4 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

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Surgery

Drug Information available for: Rivaroxaban Enoxaparin Sodium

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes [ Time Frame: Treatment period : up to day 12+/-4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE) [ Time Frame: Treatment period : up to day 12+/-4 ] [ Designated as safety issue: No ]
Incidence of symptomatic VTE (DVT, PE) [ Time Frame: Treatment period : up to day 12+/-4 ] [ Designated as safety issue: No ]
Incidence of DVT (total, proximal, distal) [ Time Frame: Treatment period : up to day 12+/-4 ] [ Designated as safety issue: No ]
Incidence of symptomatic VTE during follow-up [ Time Frame: Follow-up period: following 12+/-4 days ] [ Designated as safety issue: No ]
The composite endpoint comprising major VTE and treatment-emergent major bleeding [ Time Frame: For major VTE, treatment period: up to Day 12+/-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 ] [ Designated as safety issue: No ]
Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death [ Time Frame: Treatment period : up to day 12+/-4 ] [ Designated as safety issue: No ]
Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death [ Time Frame: Treatment period : up to day 12+/-4 ] [ Designated as safety issue: No ]
Treatment-emergent major bleedings [ Time Frame: From first dose of double-blind study medication to up to two days after last dose of double-blind study medication ] [ Designated as safety issue: Yes ]

Enrollment:	2300
Study Start Date:	June 2006
Study Completion Date:	January 2008
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Rivaroxaban (BAY59-7939) Patients will receive 10 mg rivaroxaban once daily (10mg tablet administered in the evening) plus placebo syringes of enoxaparin twice a day (once in the morning and once in the evening).
Arm 2: Active Comparator	Drug: Enoxaparin Patients will receive one placebo tablet of rivaroxaban (administered in the evening) plus syringes of enoxaparin active substance at a dose of 30 mg twice a day (once in the morning and once in the evening)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362232

Show 123 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided by Bayer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009 May 16;373(9676):1673-80. Epub 2009 May 4.

Responsible Party:	Bayer HealthCare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	11355, EudraCT: 2006-002402-60
Study First Received:	August 8, 2006
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00362232 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Prevention of venous thromboembolism

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Venous Thromboembolism
Thromboembolism

Thrombosis
Pharmacologic Actions
Enoxaparin
Embolism and Thrombosis
Fibrin Modulating Agents
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010