Study Completed

Venous Thromboembolism

Bayer Identifier:

19622

ClinicalTrials.gov Identifier:

NCT03214172

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial purpose

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

Key Participants Requirements

Sex

All

Age

18 - N/A

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

Trial summary

Enrollment Goal

1000

Trial Dates

July 2017 - September 2017

Phase

N/A

Could I Receive a placebo

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	US database	New York, 10001, United States

Primary Outcome

Recurrent Venous thromboembolism
Derived using inpatient and outpatient medical claims
Time Frame:
Retrospective analysis from November 2012 through September 2015
Bleeding (based on the Cunningham algorithm)
Derived using inpatient and outpatient medical claims
Time Frame:
Retrospective analysis from November 2012 through September 2015
Mortality (In-hospital mortality or need for hospice care without subsequent healthcare claims)
Derived using inpatient and outpatient medical claims
Time Frame:
Retrospective analysis from November 2012 through September 2015

Trial design

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

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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