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 - Full Text View

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
Prevention Venous Thromboembolism	Drug: Rivaroxaban (BAY59-7939) Drug: Enoxaparin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis Knee Replacement Pulmonary Embolism

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 13+/-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 13+/-4 ] [ Designated as safety issue: No ]
Incidence of symptomatic VTE (DVT, PE) [ Time Frame: Treatment period: up to Day 13+/-4 ] [ Designated as safety issue: No ]
Incidence of DVT (total, proximal, distal) [ Time Frame: Treatment period: up to Day 13+/-4 ] [ Designated as safety issue: No ]
Incidence of symptomatic VTE during follow-up [ Time Frame: Follow-up period: following 13+/-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 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 ] [ 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 13+/-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 13+/-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:	2530
Study Start Date:	February 2006
Study Completion Date:	January 2007

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Rivaroxaban (BAY59-7939) 10 mg rivaroxaban (tablet) once daily administered for 13 +/- 2 days
Active Comparator: Arm 2	Drug: Enoxaparin Syringe of enoxaparin at a dose of 40 mg for 13 +/- 2 days

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: NCT00361894

Show 143 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2776-86.

Responsible Party:	Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00361894 History of Changes
Other Study ID Numbers:	11356, EudraCT: 2005-004620-40
Study First Received:	August 8, 2006
Last Updated:	January 22, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Pulmonary Embolism
Thromboembolism
Venous Thrombosis
Venous Thromboembolism
Lung Diseases
Respiratory Tract Diseases
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

Thrombosis
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013

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)