Characterizing Recurrent Thromboembolism, Major Bleeding and All-Cause Death in Patients With Cancer-Associated Thromboembolism Treated With Rivaroxaban

NCT ID: NCT03214172

Last Updated: 2018-09-06

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

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-15

Study Completion Date

2017-09-15

Brief Summary

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To estimate the real-world rates of recurrent Venous thromboembolism (VTE), major bleeding and all-cause mortality in patients with Cancer-associated thrombosis (CAT) treated with rivaroxaban

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

RETROSPECTIVE

Study Groups

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Cancer-associated thrombosis

Adult patients with active cancer with at least one index venous thromboembolism (VTE) and no anticoagulation use during the 6-months (baseline period) prior to the index VTE event

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

15/20 mg

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

15/20 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients (≥18 years-of-age) with active cancer
* Patient with at least one index venous thromboembolism (VTE )
* ≥6-months of continuous eligibility prior to the index VTE event (baseline period).
* Newly initiated on rivaroxaban

Exclusion Criteria

* Patients with any medical claim for Deep vein thrombosis (DVT) or Pulmonary embolism (PE) during the 6 months pre-index date
* Patients with prescription claim for anticoagulation therapy during the 6-month pre-index VTE period
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

Locations

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US database

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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19622

Identifier Type: -

Identifier Source: org_study_id

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