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ELIQUIS (APIXABAN) Regulatory Post-Marketing Surveillance In Clinical Practice for Venous Thromboembolism (VTE) Treatment and Prevention Of Recurrent VTE

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ClinicalTrials.gov Identifier: NCT02836457
Recruitment Status : Unknown
Verified December 2017 by Bristol-Myers Squibb.
Recruitment status was:  Recruiting
First Posted : July 19, 2016
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The primary objectives of this study is to estimate the real-world safety profile of Eliquis in Japanese Venous Thromboembolism patients and to estimate the risk factors likely to affect the incidence of bleeding. Lastly, the secondary objective of this study is to estimate the real-world effectiveness profile of Eliquis in Japanese Venous Thromboembolism patients.

Condition or disease Intervention/treatment
Venous Thromboembolism Drug: ELIQUIS (APIXABAN)

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ELIQUIS (APIXABAN) Regulatory Post-Marketing Surveillance In Clinical Practice for Venous Thromboembolism (VTE) Treatment and Prevention Of Recurrent VTE
Study Start Date : July 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Groups and Cohorts
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Group/Cohort Intervention/treatment
Population with Exposure to ELIQUIS (APIXABAN) Drug: ELIQUIS (APIXABAN)


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of all treatment-related adverse events ( AE) [ Time Frame: 52 Weeks ]
  2. The incidence of serious adverse events (SAE) [ Time Frame: 52 Weeks ]
  3. The incidence of unexpected treatment-related adverse events [ Time Frame: 52 Weeks ]
    The incidence of unexpected treatment-related adverse events will be analyzed by seriousness, causality, and outcomes of adverse events

  4. The incidence of bleeding [ Time Frame: 52 Weeks ]
    The incidence of bleeding will be analyzed by seriousness, causality, and outcomes of adverse events


Secondary Outcome Measures :
  1. The incidence of venous thromboembolism (VTE) [ Time Frame: 52 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary Care Clinic
Criteria

Inclusion Criteria:

  • Patients who are initiating Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time

Exclusion Criteria:

  • Prior treatment with Eliquis for nonvalvular atrial fibrillation or VTE
  • Patients initiating Eliquis for the treatment of atrial fibrillation
  • Off-label use of Eliquis

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations
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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): NCT02836457


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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Japan
Local Institution Recruiting
Shinjuku-ku, Tokyo, Japan, 162-0822
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02836457    
Other Study ID Numbers: CV185-396
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Apixaban
Factor Xa Inhibitors
 Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants