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

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ClinicalTrials.gov Identifier: NCT02558465
Recruitment Status : Recruiting
First Posted : September 24, 2015
Last Update Posted : August 27, 2019
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Brief Summary:
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).

Condition or disease Intervention/treatment
Venous Thromboembolism Drug: Rivaroxaban (Xarelto, BAY59-7939)

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Study Type : Observational
Estimated Enrollment : 1250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of Xarelto for VTE
Actual Study Start Date : November 13, 2015
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Group/Cohort Intervention/treatment
Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxavban administration group
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Treatment parameters following the summary of product characteristics and the physician's decision




Primary Outcome Measures :
  1. Number of participants with ISTH (International Society on Thrombosis and Haemostasis) major bleeding as a measure of Safety and tolerability [ Time Frame: Up to 2 years ]
  2. Number of participants with symptomatic recurrent VTE (composite of DVT or nonfatal or fatal pulmonary embolism) [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Composite number of all-cause mortality, vascular events (acute coronary syndrome, ischemic stroke, transient ischemic attack, or systemic embolism), clinically relevant non-major bleeding and all other adverse events/ADRs [ Time Frame: Up to 2 years ]
  2. Number of participants with asymptomatic deterioration of thrombotic burden (change of D-dimer, imaging test such as CT or CCUS) by the end of standard observation period [ Time Frame: at 1 year ]
  3. Frequency of VTE recurrence and adverse events/ADRs comparison between distal and/or proximal DVT localization treatment outcomes [ Time Frame: Up to 2 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female and male patients who start rivaroxaban for VTE (pulmonary embolism, deep vein thrombosis) anticoagulation therapy
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558465


Contacts
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Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

Locations
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Japan
Many locations Recruiting
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02558465     History of Changes
Other Study ID Numbers: 17522
XAR-PE-DVT ( Other Identifier: company internal )
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
Keywords provided by Bayer:
Xarelto, rivaroxaban, VTE, PE, DVT, Japan, PMS, SDUI
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants