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Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)

NCT ID: NCT02558465

Last Updated: 2022-11-01

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

2540 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-13

Study Completion Date

2021-05-31

Brief Summary

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The objective of this investigation is to assess safety and effectiveness of Xarelto under practice routine use in VTE secondary prevention after acute DVT, focusing on hemorrhagic-related AEs, recurrent venous thromboembolism (PE/DVT), all-cause mortality. This study is a company sponsored, one- arm prospective cohort study with patients to whom Rivaroxaban treatment for VTE (PE/DVT) has been chosen. The study includes a standard observation period (1 year) and an extension survey period (2 years, at the longest).

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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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Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxavban administration group

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

Treatment parameters following the summary of product characteristics and the physician's decision

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

Treatment parameters following the summary of product characteristics and the physician's decision

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Patients who start rivaroxaban for VTE(pulmonary embolism, deep vein thrombosis) anticoagulation therapy.

Exclusion Criteria

\- Patients who are contraindicated based on the product label and have already received Xarelto treatment.
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

Multiple Locations, , Japan

Site Status

Countries

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Japan

References

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Fukuda I, Hirayama A, Kawasugi K, Kobayashi T, Maeda H, Nakamura M, Yamada N, Tajima T, Tachiiri M, Okayama Y, Sunaya T, Hirano K, Hayasaki T. Safety Profile and Effectiveness of Rivaroxaban for Patients With Venous Thromboembolism in Japan - Results From Post-Marketing Surveillance (XASSENT). Circ J. 2023 Aug 25;87(9):1175-1184. doi: 10.1253/circj.CJ-23-0104. Epub 2023 May 27.

Reference Type DERIVED
PMID: 37245989 (View on PubMed)

Related Links

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http://clinicaltrials.bayer.com/

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Other Identifiers

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XAR-PE-DVT

Identifier Type: OTHER

Identifier Source: secondary_id

17522

Identifier Type: -

Identifier Source: org_study_id

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