check_circleStudy Completed

Treatment of Venous Thromboembolism in Cancer Patients, Venous thromboembolism, Cancer

Bayer Identifier:

22290

ClinicalTrials.gov Identifier:

NCT05461807

EudraCT Number:

Not Available

EU CT Number:

Not Available
An observational study called H2H-OSCAR-US to learn more about how well rivaroxaban works and how safe it is compared to apixaban under real world conditions in people in the US with cancer who have problems due to formation of blood clots in the veins (venous thromboembolism)

Trial purpose

This is an observational study in which patient data from the past on venous thromboembolism (VTE) in people with cancer is studied. In observational studies, only observations are made without specified advice or interventions.
People with VTE have problems due to the formation of blood clots in the veins. Blood clots can reduce the flow of blood to vital organs such as the lungs, which can lead to their damage. VTE can also be “recurrent”. This means that the blood clots have returned after treatment. People who have cancer are more likely to develop VTE, recurrent clots, and bleeding on blood thinning treatments.
To prevent the formation of new or recurrent clots in people with cancer, a newer type of blood thinner is available, called direct-acting oral anticoagulant (DOAC). Rivaroxaban and apixaban are the most used DOACs in the US. They work by blocking a certain step in the blood clotting process, the activation of a protein called Factor X.
Previous studies show that DOACs may reduce clot risk compared to other available treatments but may potentially lead to more frequent bleeding. Studies looking at these points in direct comparison of rivaroxaban and apixaban a currently missing.
Therefore, this study will collect real-world data from the US to learn how well rivaroxaban works and how safe it is compared to apixaban in people with cancer and VTE who are at low risk for bleeding.

To do this, researchers will look at the proportion of patients that will develop:
•   recurrent blood clots in the veins after treatment
•   bleeding in a critical organ
•   bleeding that requires a hospital stay
within 3 and 6 months after participants had a VTE that was treated with rivaroxaban or apixaban.

De-identified data collected will cover 12 months before and at maximum 6 months after this VTE. They will come from US electronic health records and will cover the years 2012 to 2020.
No visits or tests are required as part of this study.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Be ≥18 years of age at the time of anticoagulation initiation.
    - Have active cancer defined as cancer being actively treated, diagnosed within 6-months prior of the index CAT or associated with metastatic disease (regardless of time from initial cancer diagnosis)
    - Admitted to the hospital, emergency department or observation unit for acute Deep vein thrombosis (DVT) and/or Pulmonary embolism (PE)
    - Started on a therapeutic VTE dose of rivaroxaban or apixaban within 7 days of the qualifying VTE event and treated with a therapeutic VTE dose of rivaroxaban or apixaban as their first anticoagulant on day 7 post-acute CAT event diagnosis (index date) to increase the probability of accurately classifying patients’ intended outpatient anticoagulant for CAT treatment, and that, patients are compared at the same point from diagnosis.
    - Have been active in the data set for at least 12-months prior to the index event (based on the “First Month Active” field) and had at least one provider visit in the 12-months prior to the acute VTE event (baseline period).
  • - Oesophageal, gastric, unresected colorectal, bladder, central nervous system cancers (except brain) and leukaemia
    - Evidence of atrial fibrillation, recent hip/knee replacement (within 35 days of index VTE), ongoing VTE treatment, valvular heart disease defined as any rheumatic heart disease, mitral stenosis, or mitral valve repair/replacement.
    - Pregnancy.
    - Initiation of non-therapeutic VTE doses of rivaroxaban or apixaban.
    - Evidence of anticoagulation use written prescription or patient self-report during the 12-months prior to the qualifying CAT event per.

Trial summary

Enrollment Goal
2437
Trial Dates
July 2022 - October 2022
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
BayerWuppertal, 42096, Germany

Primary Outcome

  • Composite of recurrent VTE (fatal and non-fatal) or any bleed resulting in hospitalization (per the Cunningham algorithm) at 3 months
    date_rangeTime Frame:
    Retrospective data analysis from January,2013 to December,2020
  • Composite of recurrent VTE (fatal and non-fatal) or any critical organ bleed (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, or pericardial, or intramuscular with compartment syndrome) at 3 months
    date_rangeTime Frame:
    Retrospective data analysis from January,2013 to December,2020
  • Recurrent VTE (fatal and non-fatal) at 3 months
    date_rangeTime Frame:
    Retrospective data analysis from January,2013 to December,2020
  • Any bleed resulting in hospitalization (per the Cunningham algorithm) at 3 months
    date_rangeTime Frame:
    Retrospective data analysis from January,2013 to December,2020
  • Critical organ bleeding (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, or pericardial, or intramuscular with compartment syndrome) at 3 months
    date_rangeTime Frame:
    Retrospective data analysis from January,2013 to December,2020

Secondary Outcome

  • Composite of recurrent VTE (fatal and non-fatal) or any bleed resulting in hospitalization (per the Cunningham algorithm) at 6 months
    date_rangeTime Frame:
    Retrospective data analysis from January,2013 to December,2020
  • Composite of recurrent VTE (fatal and non-fatal) or any critical organ bleed (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, or pericardial, or intramuscular with compartment syndrome) at 6 months
    date_rangeTime Frame:
    Retrospective data analysis from January,2013 to December,2020
  • Recurrent VTE (fatal and non-fatal) at 6 months
    date_rangeTime Frame:
    Retrospective data analysis from January,2013 to December,2020
  • Any bleed resulting in hospitalization (per the Cunningham algorithm) at 6 months
    date_rangeTime Frame:
    Retrospective data analysis from January,2013 to December,2020
  • Critical organ bleeding (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, or pericardial, or intramuscular with compartment syndrome) at 6 months
    date_rangeTime Frame:
    Retrospective data analysis from January,2013 to December,2020

Trial design

Effectiveness and Safety of Rivaroxaban Compared with Apixaban in Cancer-Associated Venous Thromboembolism: A Head-to-Head (H2H) Analysis of the United States Cohort of the Observational Study in Cancer Associated Thrombosis for Rivaroxaban (H2H-OSCAR-US)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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