Treatment of Venous Thromboembolism in Cancer PatientsH2H-OSCAR-USNCT05461807
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)
An observational study of Treatment of Venous Thromboembolism in Cancer Patients and Venous Thromboembolism, run by Bayer at 1 site in Germany.
Trial summary
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. 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, Venous Thromboembolism, Cancer
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939) and Apixaban
- How many people
- 2,437 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jul 2022to 5 Oct 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 excluding oesophageal, gastric, unresected colorectal, bladder, central nervous system cancers (except brain) and leukaemia (a cohort of CAT patients at a low risk for bleeding, which is defined as per ISTH guidelines), experiencing a hospital, emergency department, or observation unit admission with a primary diagnosis code for VTE, who received therapeutic VTE doses of rivaroxaban or apixaban as their first outpatient anticoagulant (index event) within 7-days of the acute VTE event and were active in the data set for at least 12-months prior to the CAT event and with at least one provider visit in the 12-months prior to the acute CAT event (establishing a 12-month look back/baseline period).
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read more
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.
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), Apixaban
- Medical subject headings
- Venous Thromboembolism, Neoplasms
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 United States Optum De-Identified Electronic Health Records data
ApixabanDrug
Retrospective cohort analysis using United States Optum De-Identified Electronic Health Records data
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients with venous thromboembolism (VTE) | Adults diagnosed with active (primary or metastatic) cancer excluding oesophageal, gastric, unresected colorectal, bladder, central nervous system cancers (except brain) and leukaemia (a cohort of CAT (Cancer-associated thrombosis) patients at a low risk for bleeding, which is defined as per the ISTH (International Society on Thrombosis and Haemostasis) guidelines), admitted to the hospital, emergency department or observation unit for acute DVT (Deep vein thrombosis) and/or PE (Pulmonary embolism) on or after January 1, 2013 (to correspond with the US availability of rivaroxaban for VTE treatment), being treated with a therapeutic VTE dose of rivaroxaban or apixaban on day 7 post-acute VTE diagnosis (index date). Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of recurrent VTE (fatal and non-fatal) or any bleed resulting in hospitalization (per the Cunningham algorithm) at 3 months
Measured: 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
Measured: Retrospective data analysis from January,2013 to December,2020
Recurrent VTE (fatal and non-fatal) at 3 months
Measured: Retrospective data analysis from January,2013 to December,2020
Any bleed resulting in hospitalization (per the Cunningham algorithm) at 3 months
Measured: 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
Measured: Retrospective data analysis from January,2013 to December,2020
Secondary outcomes (5)
Composite of recurrent VTE (fatal and non-fatal) or any bleed resulting in hospitalization (per the Cunningham algorithm) at 6 months
Measured: 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
Measured: Retrospective data analysis from January,2013 to December,2020
Recurrent VTE (fatal and non-fatal) at 6 months
Measured: Retrospective data analysis from January,2013 to December,2020
Any bleed resulting in hospitalization (per the Cunningham algorithm) at 6 months
Measured: 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
Measured: Retrospective data analysis from January,2013 to December,2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start14 Jul 2022
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
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
- 2,437 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
- NCT05461807
- Sponsor's protocol ID
- 22290
- Acronym
- H2H-OSCAR-US
- Status last verified
- Oct 2022
- First submitted
- 14 Jul 2022
- Last updated
- 26 Oct 2022
- 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
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05461807
- Acronym / sponsor ID
- H2H-OSCAR-US / 22290
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,437 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 18 Jul 2022 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients with venous thromboembolism (VTE) | – | Drug: Rivaroxaban (Xarelto, BAY59-7939), Drug: ApixabanAdults diagnosed with active (primary or metastatic) cancer excluding oesophageal, gastric, unresected colorectal, bladder, central nervous system cancers (except brain) and leukaemia (a cohort of CAT (Cancer-associated thrombosis) patients at a low risk for bleeding, which is defined as per the ISTH (International Society on Thrombosis and Haemostasis) guidelines), admitted to the hospital, emergency department or observation unit for acute DVT (Deep vein thrombosis) and/or PE (Pulmonary embolism) on or after January 1, 2013 (to correspond with the US availability of rivaroxaban for VTE treatment), being treated with a therapeutic VTE dose of rivaroxaban or apixaban on day 7 post-acute VTE diagnosis (index date). |
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 excluding oesophageal, gastric, unresected colorectal, bladder, central nervous system cancers (except brain) and leukaemia (a cohort of CAT patients at a low risk for bleeding, which is defined as per ISTH guidelines), experiencing a hospital, emergency department, or observation unit admission with a primary diagnosis code for VTE, who received therapeutic VTE doses of rivaroxaban or apixaban as their first outpatient anticoagulant (index event) within 7-days of the acute VTE event and were active in the data set for at least 12-months prior to the CAT event and with at least one provider visit in the 12-months prior to the acute CAT event (establishing a 12-month look back/baseline period).
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
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 United States Optum De-Identified Electronic Health Records data | Drug | Cancer patients with venous thromboembolism (VTE) |
| ApixabanRetrospective cohort analysis using United States Optum De-Identified Electronic Health Records data | Drug | Cancer patients with venous thromboembolism (VTE) |
Primary outcome
Composite of recurrent VTE (fatal and non-fatal) or any bleed resulting in hospitalization (per the Cunningham algorithm) at 3 months
Time 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
Time frame: Retrospective data analysis from January,2013 to December,2020
Recurrent VTE (fatal and non-fatal) at 3 months
Time frame: Retrospective data analysis from January,2013 to December,2020
Any bleed resulting in hospitalization (per the Cunningham algorithm) at 3 months
Time 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
Time frame: Retrospective data analysis from January,2013 to December,2020
5 secondary outcomes
Composite of recurrent VTE (fatal and non-fatal) or any bleed resulting in hospitalization (per the Cunningham algorithm) at 6 months
Time 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
Time frame: Retrospective data analysis from January,2013 to December,2020
Recurrent VTE (fatal and non-fatal) at 6 months
Time frame: Retrospective data analysis from January,2013 to December,2020
Any bleed resulting in hospitalization (per the Cunningham algorithm) at 6 months
Time 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
Time frame: Retrospective data analysis from January,2013 to December,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 26 Oct 2022.
- Derived from this study: PubMed 37435565Caroti 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.
- 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 and Venous Thromboembolism, run by Bayer at 1 site in Germany.
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 5 inclusion and 5 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 26 Oct 2022. 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 Germany. 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?
Composite of recurrent VTE (fatal and non-fatal) or any bleed resulting in hospitalization (per the Cunningham algorithm) at 3 months (time frame: Retrospective data analysis from January,2013 to December,2020). The study lists 5 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 NCT05461807, 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 26 Oct 2022.