Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty

NCT ID: NCT00831714

Last Updated: 2017-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19076 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-04-30

Brief Summary

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The main goal is to provide additional information to the risk-benefit assessment of the drug.

Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

Female and male patients, who are at least 18 years of age and will undergo elective hip or knee arthroplasty, after the decision for VTE prophylaxis with Rivaroxaban has been made

Group 2

Standard care treatment for VTE prophylaxis

Intervention Type DRUG

Female and male patients, who are at least 18 years of age and will undergo elective hip or knee arthroplasty, after the decision for a pharmacologic VTE prophylaxis treatment other than rivaroxaban has been made

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

Female and male patients, who are at least 18 years of age and will undergo elective hip or knee arthroplasty, after the decision for VTE prophylaxis with Rivaroxaban has been made

Intervention Type DRUG

Standard care treatment for VTE prophylaxis

Female and male patients, who are at least 18 years of age and will undergo elective hip or knee arthroplasty, after the decision for a pharmacologic VTE prophylaxis treatment other than rivaroxaban has been made

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female and male patients who will undergo elective hip or knee arthroplasty.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Australia

Site Status

Many Locations, , Austria

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Many Locations, , Belgium

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Many Locations, , Bosnia and Herzegovina

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Many Locations, , Brazil

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Many Locations, , Canada

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Many Locations, , Chile

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Many Locations, , China

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Many Locations, , Colombia

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Many Locations, , Cyprus

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Many Locations, , Czechia

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Many Locations, , Denmark

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Many Locations, , Estonia

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Many Locations, , Finland

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Many Locations, , France

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Many Locations, , Germany

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Many Locations, , Greece

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Many Locations, , Hong Kong

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Many Locations, , Hungary

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Many Locations, , India

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Many Locations, , Italy

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Many Locations, , Latvia

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Many Locations, , Lebanon

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Many Locations, , Lithuania

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Many Locations, , Mexico

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Many Locations, , Netherlands

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Many Locations, , North Macedonia

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Many Locations, , Norway

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Many Locations, , Philippines

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Many Locations, , Portugal

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Many Locations, , Serbia

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Many Locations, , Singapore

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Many Locations, , Slovakia

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Many Locations, , South Africa

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Many Locations, , South Korea

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Many Locations, , Spain

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Many Locations, , Sweden

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Many Locations, , Switzerland

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Many Locations, , United Arab Emirates

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Many Locations, , United Kingdom

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Many Locations, , Venezuela

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Many Locations, , Vietnam

Site Status

Countries

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Australia Austria Belgium Bosnia and Herzegovina Brazil Canada Chile China Colombia Cyprus Czechia Denmark Estonia Finland France Germany Greece Hong Kong Hungary India Italy Latvia Lebanon Lithuania Mexico Netherlands North Macedonia Norway Philippines Portugal Serbia Singapore Slovakia South Africa South Korea Spain Sweden Switzerland United Arab Emirates United Kingdom Venezuela Vietnam

References

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Turpie AG, Haas S, Kreutz R, Mantovani LG, Pattanayak CW, Holberg G, Jamal W, Schmidt A, van Eickels M, Lassen MR. A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment. Thromb Haemost. 2014 Jan;111(1):94-102. doi: 10.1160/TH13-08-0666. Epub 2013 Oct 24.

Reference Type BACKGROUND
PMID: 24154549 (View on PubMed)

Turpie AG, Schmidt AC, Kreutz R, Lassen MR, Jamal W, Mantovani L, Haas S. Rationale and design of XAMOS: noninterventional study of rivaroxaban for prophylaxis of venous thromboembolism after major hip and knee surgery. Vasc Health Risk Manag. 2012;8:363-70. doi: 10.2147/VHRM.S30064. Epub 2012 Jun 1.

Reference Type DERIVED
PMID: 22701330 (View on PubMed)

Other Identifiers

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XA0801

Identifier Type: OTHER

Identifier Source: secondary_id

13802

Identifier Type: -

Identifier Source: org_study_id

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