Treatment of Venous Thromboembolism in Cancer PatientsNCT05150938
A Study to Gather Information About Rivaroxaban in Patients in Sweden With Cancer Who Also Have Thrombosis (OSCAR-SE)
An observational study of Treatment of Venous Thromboembolism in Cancer Patients, run by Bayer at 1 site in Sweden.
Trial summary
This is an observational study in which patient data from the past on venous thromboembolism (VTE) in patients with cancer is studied. VTE is a condition in which a patient has problems due to the formation of blood clots in the veins. 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), Low molecular weight heparin (LMWH) and vitamin K antagonist (VKA)
- How many people
- 5,737 participants
- Where
- 1 siteSweden
- Study dates
- 18 Mar 2022to 28 Feb 2023
- 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: All patients diagnosed with cancer in Sweden from year 2013 to 2019.
Who may be able to join
- A resident in Sweden of 18+ years of age
- A Swedish Person Identification Number
- A diagnosis of cancer ((ICD10 = C00-C97) in the Swedish Cancer registry during 2013-2019 and a diagnosis of VTE subsequent to the cancer diagnosis.
Who cannot join
- A diagnosis of atrial fibrillation, total hip or knee replacement or acute coronary syndrome (for evaluation of treatment patterns) before the date of VTE diagnosis
- A dispensed prescription for any oral anticoagulant (OAC) before the date of VTE diagnosis
- A cancer diagnosis associated with high bleeding risk, including upper gastrointestinal cancer, malignant immunoproliferative diseases and leukemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden (OSCAR-SE)
This is an observational study in which patient data from the past on venous thromboembolism (VTE) in patients with cancer is studied.
VTE is a condition in which a patient has 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 heart and lungs, which can lead to them becoming damaged. VTE can also be "recurrent". This means that the blood clots have returned after treatment. People who have cancer have an increased risk of developing VTE.
Read more
Three main types of anticoagulation treatments ("blood thinners") have been available for patients with cancer who also have VTE
- Low molecular weight heparins (LMWHs)
- Vitamin K antagonists (VKAs)
- Non-vitamin K antagonist oral anticoagulants (NOACs) The treatment rivaroxaban belongs to the NOACs.
Compared to other treatments available to patients who have cancer and VTE, NOACs may cause fewer medical problems and can be easier for patients to take correctly.
In this study, the researchers will collect data about:
- the type of VTE treatments given and for how long the treatments are taken
- the risk of blood clots returning in the veins after treatment, any events of major bleeding, and the number of deaths in patients with cancer who do not have a high risk of bleeding
The researchers will compare this information in the patients
- who received rivaroxaban to the patients who received LMWHs
- who received NOACs to the patients who received LMWHs.
There will be no required visits with a study doctor or required tests in this study. The researchers will look at the health information from adult patients in Sweden who were diagnosed with cancer between 2013 and 2019 and also have VTE. The researchers will collect this information from Swedish health registers including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), Low molecular weight heparin (LMWH), vitamin K antagonist (VKA), other NOACs
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 Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
Low molecular weight heparin (LMWH)Drug
Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
vitamin K antagonist (VKA)Drug
Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
other NOACsDrug
Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients with VTE | Cancer patients who received anticoagulation treatment. Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Low molecular weight heparin (LMWH); Drug: vitamin K antagonist (VKA); Drug: other NOACs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of VTE
Measured: Retrospective data analysis from 2013 to 2020
Major bleedings
Measured: Retrospective data analysis from 2013 to 2020
All-cause death
Measured: Retrospective data analysis from 2013 to 2020
Choice of anticoagulation treatments for VTE
Measured: Retrospective data analysis from 2013 to 2020
Duration of anticoagulation treatments for VTE
Measured: Retrospective data analysis from 2013 to 2020
Recurrence of VTE with different treatment types of LMWH, VKA and NOAC
Measured: Retrospective data analysis from 2013 to 2020
Major bleedings with different treatment types of LMWH, VKA and NOAC
Measured: Retrospective data analysis from 2013 to 2020
All-cause death with different treatment types of LMWH, VKA and NOAC
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 Dec 2021
- Study start18 Mar 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 5,737 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
- NCT05150938
- Sponsor's protocol ID
- 21616
- Status last verified
- Dec 2023
- First submitted
- 18 Nov 2021
- Last updated
- 18 Dec 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.
Publications
Linder M, Ekbom A, Brobert G, Vogtlander K, Balabanova Y, Becattini C, Carrier M, Cohen AT, Coleman CI, Khorana AA, Lee AYY, Psaroudakis G, Abdelgawwad K, Rivera M, Schaefer B, Giunta DH. Comparison of rivaroxaban and low molecular weight heparin in the treatment of cancer-associated venous thromboembolism: a Swedish national population-based register study. J Thromb Thrombolysis. 2024 Aug;57(6):973-983. doi: 10.1007/s11239-024-02992-1. Epub 2024 May 12.
PubMed 38735015
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden (OSCAR-SE)
- ClinicalTrials.gov ID
- NCT05150938
- Acronym / sponsor ID
- 21616
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,737 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 9 Dec 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.
This is an observational study in which patient data from the past on venous thromboembolism (VTE) in patients with cancer is studied.
VTE is a condition in which a patient has 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 heart and lungs, which can lead to them becoming damaged. VTE can also be "recurrent". This means that the blood clots have returned after treatment. People who have cancer have an increased risk of developing VTE.
Three main types of anticoagulation treatments ("blood thinners") have been available for patients with cancer who also have VTE
- Low molecular weight heparins (LMWHs)
- Vitamin K antagonists (VKAs)
- Non-vitamin K antagonist oral anticoagulants (NOACs) The treatment rivaroxaban belongs to the NOACs.
Compared to other treatments available to patients who have cancer and VTE, NOACs may cause fewer medical problems and can be easier for patients to take correctly.
In this study, the researchers will collect data about:
- the type of VTE treatments given and for how long the treatments are taken
- the risk of blood clots returning in the veins after treatment, any events of major bleeding, and the number of deaths in patients with cancer who do not have a high risk of bleeding
The researchers will compare this information in the patients
- who received rivaroxaban to the patients who received LMWHs
- who received NOACs to the patients who received LMWHs.
There will be no required visits with a study doctor or required tests in this study. The researchers will look at the health information from adult patients in Sweden who were diagnosed with cancer between 2013 and 2019 and also have VTE. The researchers will collect this information from Swedish health registers including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
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: Low molecular weight heparin (LMWH), Drug: vitamin K antagonist (VKA), Drug: other NOACsCancer patients who received anticoagulation treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with cancer in Sweden from year 2013 to 2019.
Key inclusion criteria (3 listed)
- A resident in Sweden of 18+ years of age
- A Swedish Person Identification Number
- A diagnosis of cancer ((ICD10 = C00-C97) in the Swedish Cancer registry during 2013-2019 and a diagnosis of VTE subsequent to the cancer diagnosis.
Key exclusion criteria (3 listed)
- A diagnosis of atrial fibrillation, total hip or knee replacement or acute coronary syndrome (for evaluation of treatment patterns) before the date of VTE diagnosis
- A dispensed prescription for any oral anticoagulant (OAC) before the date of VTE diagnosis
- A cancer diagnosis associated with high bleeding risk, including upper gastrointestinal cancer, malignant immunoproliferative diseases and leukemia
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 Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry. | Drug | Cancer patients with VTE |
| Low molecular weight heparin (LMWH)Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry. | Drug | Cancer patients with VTE |
| vitamin K antagonist (VKA)Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry. | Drug | Cancer patients with VTE |
| other NOACsRetrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry. | Drug | Cancer patients with VTE |
Primary outcome
Recurrence of VTE
Time frame: Retrospective data analysis from 2013 to 2020
Major bleedings
Time frame: Retrospective data analysis from 2013 to 2020
All-cause death
Time frame: Retrospective data analysis from 2013 to 2020
Choice of anticoagulation treatments for VTE
Time frame: Retrospective data analysis from 2013 to 2020
Duration of anticoagulation treatments for VTE
Time frame: Retrospective data analysis from 2013 to 2020
Recurrence of VTE with different treatment types of LMWH, VKA and NOAC
Time frame: Retrospective data analysis from 2013 to 2020
Major bleedings with different treatment types of LMWH, VKA and NOAC
Time frame: Retrospective data analysis from 2013 to 2020
All-cause death with different treatment types of LMWH, VKA and NOAC
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 18 Dec 2023.
- Derived from this study: PubMed 38735015Linder M, Ekbom A, Brobert G, Vogtlander K, Balabanova Y, Becattini C, Carrier M, Cohen AT, Coleman CI, Khorana AA, Lee AYY, Psaroudakis G, Abdelgawwad K, Rivera M, Schaefer B, Giunta DH. Comparison of rivaroxaban and low molecular weight heparin in the treatment of cancer-associated venous thromboembolism: a Swedish national population-based register study. J Thromb Thrombolysis. 2024 Aug;57(6):973-983. doi: 10.1007/s11239-024-02992-1. Epub 2024 May 12.
- 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 Sweden.
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 3 inclusion and 3 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 18 Dec 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 Sweden. 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?
Recurrence of VTE (time frame: Retrospective data analysis from 2013 to 2020). The study lists 8 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 NCT05150938, which also lists 1 linked publication.
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 18 Dec 2023.