check_circleStudy 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
  • - 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
  • - 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
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
US databaseNew York, 10001, United States

Primary Outcome

  • Recurrent Venous thromboembolism
    Derived using inpatient and outpatient medical claims
    date_rangeTime Frame:
    Retrospective analysis from November 2012 through September 2015
  • Bleeding (based on the Cunningham algorithm)
    Derived using inpatient and outpatient medical claims
    date_rangeTime 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
    date_rangeTime 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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