Eliquis (VTE Treatment and Prevention of Recurrent VTE) rPMS

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

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-09-29

Brief Summary

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To assess the real-world safety/effectiveness of Eliquis in Korean venous thromboembolism (VTE) patients and patient characteristics that are associated with bleeding among patients taking Eliquis. To identify factors that might be associated with the safety and effectiveness profile in Korean VTE patients.

Detailed Description

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Conditions

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Venous Thromboembolism

Keywords

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Treatment Tx Prevent

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adult (≥19 years of age) patients who are initiating treatment with Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time in accordance with the Korean package insert will be enrolled in the study

Exclusion Criteria

* Patients with prior treatment with Eliquis before enrollment in this study
* Patients receiving Eliquis treatment for an indication not approved indication in Korea
* Patients meeting any of the following criteria will not be included in the study:

i) Hypersensitivity to the active substance or to any of the excipients

ii) Clinically significant active bleeding

iii) Hepatic disease associated with coagulopathy and clinically relevant bleeding risk

iv) Patients with increased bleeding risk due to such as following diseases:

1. Recent gastrointestinal ulceration history
2. Recent intracranial or intracerebral haemorrhage history
3. Intraspinal or intracerebral vascular abnormalities
4. Recent brain, spinal or ophthalmic surgery history
5. Recent brain or spinal injury
6. Known or suspected oesophageal varices
7. Arteriovenous malformations
8. Vascular aneurysms
9. Patients with malignant neoplasms at high risk of bleeding

* Concomitant treatment with any other anticoagulant agent:

i) Unfractionated heparin (UFH)

ii) Low molecular weight heparins (enoxaparin, dalteparin, etc)

iii) Heparin derivatives (fondaparinux, etc)

iv) oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc) except under the circumstances of switching therapy to or from apixaban or when UFH is given at doses necessary to maintain a patent central venous or arterial catheter

* Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CV185-440

Identifier Type: -

Identifier Source: org_study_id