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Treatment of Venous Thromboembolism in Cancer PatientsOSCAR-USNCT04979780

Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort

An observational study of Treatment of Venous Thromboembolism in Cancer Patients and Prophylaxis of Recurrent Venous Thromboembolism in Cancer Patients, run by Bayer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with active cancer are ~5-fold more likely to develop a venous thromboembolism (VTE) than those without. When VTE occurs, cancer patients carry an up to a 3-fold higher rate of thrombosis recurrence and ~twice the risk of bleeding during anticoagulation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rivaroxaban (Xarelto, BAY59-7939), Low molecular weight heparin (LMWH) and Direct Oral Anticoagulants (DOAC)
Type of treatment
Pill or oral medicine
How many people
3,708 participants
Where
1 siteUnited States
Study dates
20 Jul 2021to 31 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: The Optum EHR database includes longitudinal patient-level medical record data for ~91+ million patients seen at ~700+ hospitals and ~7,000+ clinics across the US. The study population of interest will be patients with cancer, admitted to the hospital, emergency department or observation unit for acute DVT and/or PE on or after January 1, 2013 (to correspond with the US availability of rivaroxaban for VTE treatment), being treated with rivaroxaban (or any DOAC in secondary analysis) or LMWH on day 7 post-acute VTE diagnosis (index date), and 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).

Who may be able to join

  • Be ≥18 years of age at the time of anticoagulation initiation.
  • Have active cancer admitted to the hospital, emergency department or observation unit for acute DVT and/or PE.
  • Treated with rivaroxaban (or any DOAC in secondary analysis) or LMWH as their first anticoagulant on day 7 post-acute CAT event diagnosis (index date) o 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).

Who cannot join

  • 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 rivaroxaban at a dose other than 15 mg twice daily or non-therapeutic doses of other DOAC or LMWH (e.g., enoxaparin at a dose other than 1 mg/kg twice daily or 1.5 mg/kg once daily; dalteparin at a dose other than 200 IU/kg of total body weight)
  • Evidence of use of anticoagulation use during the 12-months prior per written prescription or patient self-report

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Many Locations

    Multiple Locations, Connecticut, 06093

Other trials in United States

About this study

Patients with active cancer are ~5-fold more likely to develop a venous thromboembolism (VTE) than those without. When VTE occurs, cancer patients carry an up to a 3-fold higher rate of thrombosis recurrence and ~twice the risk of bleeding during anticoagulation. Therefore, it is critical to utilize anticoagulants that optimize efficacy while minimizing bleeding risk when treating cancer-associated thrombosis (CAT).

Guidelines list direct-acting oral anticoagulants (DOACs) as an alternative to low molecular-weight heparin (LMWH) for treatment of CAT. The strength-of-recommendation for DOACs is based on data from multiple randomized controlled trials (RCTs) comparing them to LMWHs to treat CAT, with results suggesting DOACs may reduce thrombosis risk but with potentially more frequent bleeding (particularly in those with certain gastrointestinal and genitourinary cancers).

Read more

Observational studies evaluating DOACs for CAT treatment have been published, but these studies have been either single-arm, evaluated cancer subtypes not recommended for DOAC treatment, were of limited sample size and/or employed heterogeneous definitions of active cancer. We seek to evaluate the effectiveness and safety of rivaroxaban versus LMWH for CAT treatment in active cancer patients using a large de-identified electronic health record database.

Retrospective cohort analysis using US Optum® De-Identified EHR data. We will use Optum EHR (electronic health records) data from November January 1, 2012 through latest available data (currently September 2020).

Being tested
Rivaroxaban (Xarelto, BAY59-7939), Low molecular weight heparin (LMWH), Direct Oral Anticoagulants (DOAC)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    Retrospective cohort analysis using US Optum De-Identified EHR data.

  • Low molecular weight heparin (LMWH)Drug

    Retrospective cohort analysis using US Optum De-Identified EHR data. LMWH (dalteparin, enoxaparin, tinzaparin)

  • Direct Oral Anticoagulants (DOAC)Drug

    Retrospective cohort analysis using US Optum De-Identified EHR data. DOAC (apixaban, dabigatran, edoxaban, rivaroxaban).

Study groups in NCT04979780
Study groupRoleWhat they receive
Cancer patients with acute venous thromboembolism (VTE)Cancer-associated thrombosis (CAT) patients treated with Rivaroxaban or any DOAC (Direct Oral Anticoagulants) or LMWH (Low molecular weight heparin).
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Low molecular weight heparin (LMWH); Drug: Direct Oral Anticoagulants (DOAC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Risk of recurrent VTE

    Measured: at 3 month after treatment

  2. Any clinically-relevant bleeding-related hospitalization

    Cunningham algorithm for identification of bleeding-associated hospitalizations

    Measured: at 3 month after treatment

  3. All-cause mortality

    Measured: at 3 month after treatment

Secondary outcomes (13)

  1. Recurrent VTE at 6- and 12-months post-index VTE

    Measured: at 6 and 12 months post-index VTE

  2. Composite of any major or clinically-relevant nonmajor bleeding-related hospitalization at 6- and 12-months post-index VTE

    including:

    • Intracranial hemorrhage (ICH)
    • Critical organ bleeding (e.g., intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, or pericardial bleeding or intramuscular with compartment syndrome)
    • Extracranial bleeding-related hospitalizations

    Measured: at 6 and 12 months post-index VTE

  3. Any clinically-relevant bleeding-related hospitalization

    per the Cunningham algorithm for identification of bleeding-associated hospitalizations

    Measured: at 6 and 12 months

  4. Intracranial hemorrhage (ICH)

    Measured: at 3, 6 and 12 months

  5. Critical organ bleeding

    Measured: at 3, 6 and 12 months

  6. Extracranial bleeding-related hospitalizations

    Measured: at 3, 6 and 12 months

  7. All-cause mortality at 6- and 12-months.

    Measured: at 6 and 12 months

  8. Incidence rates of recurrent VTE

    Incidence rates of recurrent VTE in DOAC and LMWH patients experiencing CAT regardless of the bleeding risk associated with cancer type.

    Measured: at 3, 6 and 12 months

  9. Incidence rates any clinically-relevant bleeding-related to recurrent VTE

    Incidence rates of any clinically-relevant bleeding-related in DOAC and LMWH patients experiencing CAT regardless of the bleeding risk associated with cancer type.

    Measured: at 3, 6 and 12 months

  10. All cause-mortality

    Incidence rates of all cause-mortality in DOAC and LMWH patients experiencing CAT regardless of the bleeding risk associated with cancer type.

    Measured: at 3, 6 and 12 months

  11. Duration of anticoagulation treatment

    Measured: at 3, 6 and 12 months

  12. DOAC discontinuation rates at 3-, 6- and 12-months follow-up

    Measured: at 3, 6 and 12 months

  13. LMWH discontinuation rates at 3-, 6- and 12-months follow-up

    Measured: at 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2021
  2. Study start20 Jul 2021
  3. Primary completion31 Mar 2022
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
3,708 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04979780
Sponsor's protocol ID
21982
Acronym
OSCAR-US
Status last verified
Oct 2024
First submitted
19 Jul 2021
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

  • Caroti KS, Becattini C, Carrier M, Cohen AT, Ekbom A, Khorana AA, Lee AYY, Brescia C, Abdelgawwad K, Psaroudakis G, Rivera M, Schaefer B, Brobert G, Coleman CI. Rivaroxaban versus Apixaban for Treatment of Cancer-Associated Venous Thromboembolism in Patients at Lower Risk of Bleeding. TH Open. 2023 Jul 10;7(3):e206-e216. doi: 10.1055/s-0043-1770783. eCollection 2023 Jul.

    PubMed 37435565

  • Coleman CI, Caroti KS, Abdelgawwad K, Psaroudakis G, Fatoba S, Rivera M, Schaefer B, Brobert G, Khorana AA, Becattini C, Lee AYY, Ekbom A, Carrier M, Brescia C, Cohen AT. Effectiveness and Safety of Rivaroxaban and Low Molecular Weight Heparin in Cancer-Associated Venous Thromboembolism. JACC CardioOncol. 2023 Feb 7;5(2):189-200. doi: 10.1016/j.jaccao.2022.10.014. eCollection 2023 Apr.

    PubMed 37144109

Questions about this trial

What is this clinical trial studying?

An observational study of Treatment of Venous Thromboembolism in Cancer Patients and Prophylaxis of Recurrent Venous Thromboembolism in Cancer Patients, run by Bayer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risk of recurrent VTE (time frame: at 3 month after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04979780, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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