Treatment of Venous Thromboembolism in Cancer PatientsNCT05112666
A Study to Gather Information About Rivaroxaban in Patients in the United Kingdom Who Have Cancer and Thrombosis (OSCAR-UK)
An observational study of Treatment of Venous Thromboembolism in Cancer Patients, run by Bayer at 1 site in United Kingdom.
Trial summary
Patients with cancer are more likely than those without cancer to develop blood clots (deep vein thrombosis and pulmonary embolism), which are treated using blood thinners (anticoagulants). When clots occur, cancer patients carry a higher risk of recurring clots and more likely to bleed on blood thinning treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment of Venous Thromboembolism in Cancer Patients
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939), other DOACs and LMWH
- Type of treatment
- Pill or oral medicine
- How many people
- 2,601 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Dec 2021to 26 Aug 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults diagnosed with active (primary or metastatic) cancer experiencing a hospitalization or emergency department admission or a primary care visit with an incident VTE, being administered rivaroxaban or other DOACs or a LMWH on or after January 1, 2013.
Who may be able to join
- Be ≥18 years of age at the time of anticoagulation initiation
- Have active cancer and acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
- Treated with rivaroxaban (or any DOAC) or LMWH as their first recorded anticoagulant prescription 7 to 30 days post-acute CAT event diagnosis
- Have been active in the data set for at least 12-months prior to the index event and had at least one provider visit in the 12-months prior to the acute VTE event
Who cannot join
- Evidence of atrial fibrillation, recent hip/knee replacement (with 90 days of CAT), ongoing VTE treatment, valvular heart disease defined as any rheumatic heart disease, mitral stenosis or mitral valve repair/replacement
- History of inferior vena cava filter before cohort entry
- vitamin K antagonist (VKA) use between cohort entry and index day (initiation of DOAC or LMWH)
- Evidence of any type of therapeutic anticoagulation use during all available look-back period per written prescription or patient self-report
- Initiation of rivaroxaban or other DOACs or LMWH during the study period at non-therapeutic doses (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)
- Pregnancy
- Recording indicative of palliative care before cohort entry
- Any clinically-relevant bleeding-related d hospitalization or VTE recurrence between the initial CAT and the start of observation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United Kingdom Cohort (OSCAR-UK)
Patients with cancer are more likely than those without cancer to develop blood clots (deep vein thrombosis and pulmonary embolism), which are treated using blood thinners (anticoagulants). When clots occur, cancer patients carry a higher risk of recurring clots and more likely to bleed on blood thinning treatments. Therefore, it is critical to use blood thinners that optimize the safety and benefits.
There are two main types of blood thinners that are recommended. The tablets which are direct-acting oral anticoagulants and the injections (low molecular-weight heparin). Clinical trials show the tablets may reduce clot risk but may potentially lead to more frequent bleeding, particularly in those with certain risk factors such as stomach ulcers, previous bleeding problems, certain cancer type.
We aim to examine the effectiveness and safety of the tablets versus the injections for treatment of clots in cancer patients, to better understand these treatments' benefits and risks.
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), other DOACs, LMWH
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 Clinical Practice Research Datalink (CPRD) GOLD and Aurum Hospital Episode Statistics (HES)-linked datasets in UK.
other DOACsDrug
Retrospective cohort analysis using CPRD GOLD and Aurum HES-linked datasets in UK.
LMWHDrug
Retrospective cohort analysis using CPRD GOLD and Aurum HES-linked datasets in UK.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients with VTE | Adults diagnosed with active (primary or metastatic) cancer experiencing a hospitalization or emergency department admission or a primary care visit with an incident venous thromboembolism (VTE), being administered rivaroxaban or other direct-acting oral anticoagulants (DOACs) or a low molecular weight heparin (LMWH) will be included. Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: other DOACs; Drug: LMWH |
What is being measured
The primary outcome is the main question the study is designed to answer.
The risk of recurrent VTE at 3-months
Measured: Retrospective data analysis from 2013 to 2020
Composite of any major bleeding or clinically-relevant non-major bleeding-related hospitalization at 3-months
Per the International Society on Thrombosis and Haemostasis (ISTH) criteria [9, 10] for identification of bleeding-associated hospitalizations.
Measured: Retrospective data analysis from 2013 to 2020
All-cause mortality at 3-months
Measured: Retrospective data analysis from 2013 to 2020
Secondary outcomes (10)
Recurrent VTE at 6- and 12-months post-index VTE
Measured: Retrospective data analysis from 2013 to 2020
Composite of any major or clinically-relevant non-major 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 (including trauma-related)
Measured: Retrospective data analysis from 2013 to 2020
Composite of any major bleeding or clinically-relevant non-major bleeding-related hospitalization at 6 and 12-months
Per the ISTH criteria [9, 10] for identification of bleeding-associated hospitalizations.
Measured: Retrospective data analysis from 2013 to 2020
Intracranial hemorrhage (ICH), critical organ bleeding and extracranial bleeding-related hospitalizations as separate outcomes
Measured: Retrospective data analysis from 2013 to 2020
All-cause mortality at 6- and 12-months
Measured: Retrospective data analysis from 2013 to 2020
Incidence rates of recurrent VTE in rivaroxaban, DOAC and LMWH patients experiencing cancer-associated thrombosis (CAT) regardless of the bleeding risk associated with cancer type
Measured: Retrospective data analysis from 2013 to 2020
Any clinically-relevant bleeding-related hospitalization in rivaroxaban, DOAC and LMWH patients experiencing cancer-associated thrombosis (CAT) regardless of the bleeding risk associated with cancer type
Measured: Retrospective data analysis from 2013 to 2020
All cause-mortality in rivaroxaban, DOAC and LMWH patients experiencing cancer-associated thrombosis (CAT) regardless of the bleeding risk associated with cancer type
Measured: Retrospective data analysis from 2013 to 2020
Duration of anticoagulation treatment
Measured: Retrospective data analysis from 2013 to 2020
Discontinuation rates of rivaroxaban, DOAC and LMWH at 3-, 6-, 12-months and all available follow-up
Measured: Retrospective data analysis from 2013 to 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start2 Dec 2021
- Primary completion26 Aug 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Venous Thromboembolism in Cancer PatientsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 2,601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112666
- Sponsor's protocol ID
- 22020
- Status last verified
- Mar 2023
- First submitted
- 28 Oct 2021
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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.vivli.org 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 member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United Kingdom Cohort (OSCAR-UK)
- ClinicalTrials.gov ID
- NCT05112666
- Acronym / sponsor ID
- 22020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,601 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with cancer are more likely than those without cancer to develop blood clots (deep vein thrombosis and pulmonary embolism), which are treated using blood thinners (anticoagulants). When clots occur, cancer patients carry a higher risk of recurring clots and more likely to bleed on blood thinning treatments. Therefore, it is critical to use blood thinners that optimize the safety and benefits.
There are two main types of blood thinners that are recommended. The tablets which are direct-acting oral anticoagulants and the injections (low molecular-weight heparin). Clinical trials show the tablets may reduce clot risk but may potentially lead to more frequent bleeding, particularly in those with certain risk factors such as stomach ulcers, previous bleeding problems, certain cancer type.
We aim to examine the effectiveness and safety of the tablets versus the injections for treatment of clots in cancer patients, to better understand these treatments' benefits and risks.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients with VTE | – | Drug: Rivaroxaban (Xarelto, BAY59-7939), Drug: other DOACs, Drug: LMWHAdults diagnosed with active (primary or metastatic) cancer experiencing a hospitalization or emergency department admission or a primary care visit with an incident venous thromboembolism (VTE), being administered rivaroxaban or other direct-acting oral anticoagulants (DOACs) or a low molecular weight heparin (LMWH) will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with active (primary or metastatic) cancer experiencing a hospitalization or emergency department admission or a primary care visit with an incident VTE, being administered rivaroxaban or other DOACs or a LMWH on or after January 1, 2013.
Key inclusion criteria (4 listed)
- Be ≥18 years of age at the time of anticoagulation initiation
- Have active cancer and acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
- Treated with rivaroxaban (or any DOAC) or LMWH as their first recorded anticoagulant prescription 7 to 30 days post-acute CAT event diagnosis
- Have been active in the data set for at least 12-months prior to the index event and had at least one provider visit in the 12-months prior to the acute VTE event
Key exclusion criteria (8 listed)
- Evidence of atrial fibrillation, recent hip/knee replacement (with 90 days of CAT), ongoing VTE treatment, valvular heart disease defined as any rheumatic heart disease, mitral stenosis or mitral valve repair/replacement
- History of inferior vena cava filter before cohort entry
- vitamin K antagonist (VKA) use between cohort entry and index day (initiation of DOAC or LMWH)
- Evidence of any type of therapeutic anticoagulation use during all available look-back period per written prescription or patient self-report
- Initiation of rivaroxaban or other DOACs or LMWH during the study period at non-therapeutic doses (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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939)Retrospective cohort analysis using Clinical Practice Research Datalink (CPRD) GOLD and Aurum Hospital Episode Statistics (HES)-linked datasets in UK. | Drug | Cancer patients with VTE |
| other DOACsRetrospective cohort analysis using CPRD GOLD and Aurum HES-linked datasets in UK. | Drug | Cancer patients with VTE |
| LMWHRetrospective cohort analysis using CPRD GOLD and Aurum HES-linked datasets in UK. | Drug | Cancer patients with VTE |
Primary outcome
The risk of recurrent VTE at 3-months
Time frame: Retrospective data analysis from 2013 to 2020
Composite of any major bleeding or clinically-relevant non-major bleeding-related hospitalization at 3-months
Time frame: Retrospective data analysis from 2013 to 2020
Per the International Society on Thrombosis and Haemostasis (ISTH) criteria [9, 10] for identification of bleeding-associated hospitalizations.
All-cause mortality at 3-months
Time frame: Retrospective data analysis from 2013 to 2020
10 secondary outcomes
Recurrent VTE at 6- and 12-months post-index VTE
Time frame: Retrospective data analysis from 2013 to 2020
Composite of any major or clinically-relevant non-major bleeding-related hospitalization at 6- and 12-months post-index VTE
Time frame: Retrospective data analysis from 2013 to 2020
Composite of any major bleeding or clinically-relevant non-major bleeding-related hospitalization at 6 and 12-months
Time frame: Retrospective data analysis from 2013 to 2020
Intracranial hemorrhage (ICH), critical organ bleeding and extracranial bleeding-related hospitalizations as separate outcomes
Time frame: Retrospective data analysis from 2013 to 2020
All-cause mortality at 6- and 12-months
Time frame: Retrospective data analysis from 2013 to 2020
Incidence rates of recurrent VTE in rivaroxaban, DOAC and LMWH patients experiencing cancer-associated thrombosis (CAT) regardless of the bleeding risk associated with cancer type
Time frame: Retrospective data analysis from 2013 to 2020
Any clinically-relevant bleeding-related hospitalization in rivaroxaban, DOAC and LMWH patients experiencing cancer-associated thrombosis (CAT) regardless of the bleeding risk associated with cancer type
Time frame: Retrospective data analysis from 2013 to 2020
All cause-mortality in rivaroxaban, DOAC and LMWH patients experiencing cancer-associated thrombosis (CAT) regardless of the bleeding risk associated with cancer type
Time frame: Retrospective data analysis from 2013 to 2020
Duration of anticoagulation treatment
Time frame: Retrospective data analysis from 2013 to 2020
Discontinuation rates of rivaroxaban, DOAC and LMWH at 3-, 6-, 12-months and all available follow-up
Time frame: Retrospective data analysis from 2013 to 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: 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.vivli.org 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 member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment of Venous Thromboembolism in Cancer Patients, run by Bayer at 1 site in United Kingdom.
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 8 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 3 Apr 2023. 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 Kingdom. 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?
The risk of recurrent VTE at 3-months (time frame: Retrospective data analysis from 2013 to 2020). 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?
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 3 Apr 2023.