Treatment of Venous Thromboembolism (VTE) With Either Rivaroxaban or Current Standard of Care Therapy

NCT ID: NCT02210819

Last Updated: 2019-08-29

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

1987 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-27

Study Completion Date

2017-01-20

Brief Summary

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Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute venous thoromboembolism (VTE).

The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute VTE in routine clinical practice.

Detailed Description

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Conditions

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Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rivaroxaban

Patients who will be treated for an acute venous thromboembolism (VTE) with rivaroxaban.

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

Cohort participants are classified as "rivaroxaban" patient, if the patient receives initial rivaroxaban VTE treatment. Dosing according to daily clinical routine

Standard of care

Patients who will be treated for an acute venous thromboembolism (VTE) with current standard of care.

Recommended VTE pharmacological treatments according to international guidelines

Intervention Type DRUG

Cohort participants are classified as "Standard of care" patients, if the patient receives recommended VTE pharmacological treatments according to international guidelines, e.g. unfractionated heparin, LMWH, fondaparinux, VKA, if these are also approved pharmacological treatments for VTE in the respective country. Dosing according to daily clinical routine.

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

Cohort participants are classified as "rivaroxaban" patient, if the patient receives initial rivaroxaban VTE treatment. Dosing according to daily clinical routine

Intervention Type DRUG

Recommended VTE pharmacological treatments according to international guidelines

Cohort participants are classified as "Standard of care" patients, if the patient receives recommended VTE pharmacological treatments according to international guidelines, e.g. unfractionated heparin, LMWH, fondaparinux, VKA, if these are also approved pharmacological treatments for VTE in the respective country. Dosing according to daily clinical routine.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female or male patients, who are at \>=18 years
* Diagnosis of acute DVT and/or PE, objectively confirmed
* Indication for anticoagulation therapy for at least 12 weeks
* Willing to participate in this study and available for follow-up
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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Multiple Locations, , Algeria

Site Status

Multiple Locations, , Egypt

Site Status

Multiple Locations, , Indonesia

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Multiple Locations, , Jordan

Site Status

Multiple Locations, , Kazakhstan

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Multiple Locations, , Kenya

Site Status

Multiple Locations, , Kuwait

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Multiple Locations, , Lebanon

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Multiple Locations, , Malaysia

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Multiple Locations, , Mexico

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Multiple Locations, , Morocco

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Multiple Locations, , Philippines

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Multiple Locations, , Qatar

Site Status

Multiple Locations, , Russia

Site Status

Multiple Locations, , Saudi Arabia

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Multiple Locations, , Singapore

Site Status

Multiple Locations, , South Korea

Site Status

Multiple Locations, , Taiwan

Site Status

Multiple Locations, , Turkey (Türkiye)

Site Status

Multiple Locations, , Ukraine

Site Status

Multiple Locations, , United Arab Emirates

Site Status

Countries

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Algeria Egypt Indonesia Jordan Kazakhstan Kenya Kuwait Lebanon Malaysia Mexico Morocco Philippines Qatar Russia Saudi Arabia Singapore South Korea Taiwan Turkey (Türkiye) Ukraine United Arab Emirates

Other Identifiers

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XA1402

Identifier Type: OTHER

Identifier Source: secondary_id

17237

Identifier Type: -

Identifier Source: org_study_id

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