Venous Thrombosis and Pulmonary EmbolismCOSIMONCT02742623
A Non-interventional Study on Xarelto for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer
An observational study of Venous Thrombosis and Pulmonary Embolism, run by Bayer at 10 sites in 10 countries.
Trial summary
This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis and Pulmonary Embolism
- What is being tested?
- Rivaroxaban (Xarelto, BAY 59-7939)
- How many people
- 528 participants
- Where
- 10 sitesin 10 countries
- Study dates
- 11 Oct 2016to 28 Mar 2019
- 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: Female and male patients with active cancer and a diagnosis of DVT/ and/or PE after the decision for treatment with rivaroxaban
Who may be able to join
- Adult female and male patients with active cancer other than fully treated basal-cell or squamous-cell carcinoma of the skin (active cancer defined as the diagnosis or treatment of cancer in the previous < 6 months or recurrent or metastatic cancer)
- Patients that have been treated with standard of care anticoagulation (Low Molecular Weight Heparin / Vitamin K Antagonist) for treatment of DVT and/ or PE (index VTE event) and/ or prevention of recurrent DVT and PE for at least 4 weeks prior to inclusion in the study
- Patients for whom the decision was made to start rivaroxaban for treatment of DVT and/ or PE and/ or prevention of recurrent DVT and PE
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
- Patients who are willing to participate in this study (signed informed consent)
- Patients who are available for follow-up with a life expectancy >6 months
Who cannot join
- The contra-indications according to the local marketing authorization must be considered
- Patients who developed an index VTE event despite chronic anticoagulant therapy
- Patients receiving apixaban, edoxaban or dabigatran or any investigational drug as the initial therapy for the index VTE event
- Patients participating in an investigational program with interventions outside of routine clinical practice with exception of oncology investigational trials
Trial locations and contacts
10 sites in 10 countries.
10 sites in 10 countries
About this study
Official title: COSIMO Cancer Associated Thrombosis - Patient Reported Outcomes With Rivaroxaban. A Non-interventional Study on Patients Changing to Xarelto® for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer.
This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).
- Conditions
- Venous Thrombosis and Pulmonary Embolism
- Being tested
- Rivaroxaban (Xarelto, BAY 59-7939)
- Keywords
- Cancer, Deep Venous Thrombosis, Pulmonary Embolism
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY 59-7939)Drug
Treatment with rivaroxaban for DVT and/ or PE and/ or prevention of recurrent DVT and PE according to local label
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Female and male patients with active cancer and treated with rivaroxaban after a diagnosis of DVT/ and/or PE Receives: Drug: Rivaroxaban (Xarelto, BAY 59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment satisfaction burden score (ACTS)
Patient reported treatment satisfaction will be assessed with regard to the Anti-Clot Treatment Scale (ACTS) burden score for the use of rivaroxaban for treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in patients with active cancer changing to this therapy.
Measured: At 4 weeks
Secondary outcomes (20)
Preferences regarding the attributes of the anticoagulation medication options LMWH, VKA, rivaroxaban using DCE survey
Discrete Choice Experiment (DCE) based preference of patients for rivaroxaban versus other anticoagulants in a semi-structured telephone interview
LMWH: Low Molecular Weight Heparin; VKA: Vitamin K Antagonist
Measured: Between 4 weeks and 3 months
Change of ACTS score over time
To assess patient reported outcomes by means of the Anti-Clot Treatment Scale (ACTS) questionnaire
Measured: At 3 months and 6 months
Patient's quality of life using the FACIT-Fatigue questionnaire
To assess patient reported outcomes on quality of life using the FACIT-Fatigue questionnaire (Functional Assessment of Chronic Illness Therapy)
Measured: Up to 6 months
Type of index VTE (venous thromboembolism) event
Measured: At baseline
Date of index VTE event
Measured: At baseline
Type (trade name) of initial anticoagulation treatment
Measured: At baseline
Duration of initial anticoagulation treatment
Measured: At baseline
Reason for drug switch to rivaroxaban
Menu items: patient choice, physician choice, side effects, other
Measured: At baseline
Planned duration of anticoagulation with rivaroxaban
Measured: At baseline
Actual duration of anticoagulation with rivaroxaban
Measured: Up to 6 months
Dosage of rivaroxaban
Measured: Up to 6 months
Reason for any potential dose adjustments during course of treatment with rivaroxaban
Menu items: side effects, intervention, other
Measured: Up to 6 months
Reasons for any switch from rivaroxaban treatment
Menu items: patient choice, physician choice, side effects, other
Measured: Up to 6 months
Reasons for permanent cessation of rivaroxaban treatment
Menu items: patient choice, physician choice, side effects, other
Measured: Up to 6 months
TNM Staging (Clinical characteristics of cancer disease)
Assessment according to TNM (Tumor, Lymph Node and Metastases) classification. TNM is developed and maintained by the Union for International Cancer Control (UICC)
Measured: At baseline
Primary site of cancer (Clinical characteristics of cancer disease)
Following Medical Dictionary for Regulatory Activities (MedDRA) coding system
Measured: At baseline
Type of bleeding events
Measured: Up to 6 months
Number of bleeding events
Measured: Up to 6 months
Type of thromboembolic events
Measured: Up to 6 months
Number of thromboembolic events
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start11 Oct 2016
- Primary completion30 Nov 2018
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venous Thrombosis and Pulmonary EmbolismStudies 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
- Prospective
- Enrolment
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742623
- Sponsor's protocol ID
- 18137
- Other IDs
- XA1502
- Acronym
- COSIMO
- Status last verified
- Nov 2023
- First submitted
- 1 Mar 2016
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Maraveyas A, Beyer-Westendorf J, Lee AY, Mantovani LG, De Sanctis Y, Abdelgawwad K, Fatoba S, Bach M, Cohen AT. Cancer-Associated ThrOmboSIs - Patient-Reported OutcoMes With RivarOxaban (COSIMO) - Baseline characteristics and clinical outcomes. Res Pract Thromb Haemost. 2021 Nov 30;5(8):e12604. doi: 10.1002/rth2.12604. eCollection 2021 Dec.
PubMed 34877446Cohen AT, Maraveyas A, Beyer-Westendorf J, Lee AYY, Mantovani LG, Bach M; COSIMO Investigators. COSIMO - patients with active cancer changing to rivaroxaban for the treatment and prevention of recurrent venous thromboembolism: a non-interventional study. Thromb J. 2018 Sep 4;16:21. doi: 10.1186/s12959-018-0176-2. eCollection 2018.
PubMed 30186045
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COSIMO Cancer Associated Thrombosis - Patient Reported Outcomes With Rivaroxaban. A Non-interventional Study on Patients Changing to Xarelto® for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer.
- ClinicalTrials.gov ID
- NCT02742623
- Acronym / sponsor ID
- COSIMO / 18137
- Conditions
- Venous Thrombosis and Pulmonary Embolism
- Keywords
- Cancer, Deep Venous Thrombosis, Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 11 Oct 2016 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 19 Apr 2016 (estimated)
- 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 study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | – | Drug: Rivaroxaban (Xarelto, BAY 59-7939)Female and male patients with active cancer and treated with rivaroxaban after a diagnosis of DVT/ and/or PE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female and male patients with active cancer and a diagnosis of DVT/ and/or PE after the decision for treatment with rivaroxaban
Key inclusion criteria (6 listed)
- Adult female and male patients with active cancer other than fully treated basal-cell or squamous-cell carcinoma of the skin (active cancer defined as the diagnosis or treatment of cancer in the previous < 6 months or recurrent or metastatic cancer)
- Patients that have been treated with standard of care anticoagulation (Low Molecular Weight Heparin / Vitamin K Antagonist) for treatment of DVT and/ or PE (index VTE event) and/ or prevention of recurrent DVT and PE for at least 4 weeks prior to inclusion in the study
- Patients for whom the decision was made to start rivaroxaban for treatment of DVT and/ or PE and/ or prevention of recurrent DVT and PE
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
- Patients who are willing to participate in this study (signed informed consent)
Key exclusion criteria (4 listed)
- The contra-indications according to the local marketing authorization must be considered
- Patients who developed an index VTE event despite chronic anticoagulant therapy
- Patients receiving apixaban, edoxaban or dabigatran or any investigational drug as the initial therapy for the index VTE event
- Patients participating in an investigational program with interventions outside of routine clinical practice with exception of oncology investigational trials
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, BAY 59-7939)Treatment with rivaroxaban for DVT and/ or PE and/ or prevention of recurrent DVT and PE according to local label | Drug | Rivaroxaban |
Primary outcome
Treatment satisfaction burden score (ACTS)
Time frame: At 4 weeks
Patient reported treatment satisfaction will be assessed with regard to the Anti-Clot Treatment Scale (ACTS) burden score for the use of rivaroxaban for treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in patients with active cancer changing to this therapy.
20 secondary outcomes
Preferences regarding the attributes of the anticoagulation medication options LMWH, VKA, rivaroxaban using DCE survey
Time frame: Between 4 weeks and 3 months
Change of ACTS score over time
Time frame: At 3 months and 6 months
Patient's quality of life using the FACIT-Fatigue questionnaire
Time frame: Up to 6 months
Type of index VTE (venous thromboembolism) event
Time frame: At baseline
Date of index VTE event
Time frame: At baseline
Type (trade name) of initial anticoagulation treatment
Time frame: At baseline
Duration of initial anticoagulation treatment
Time frame: At baseline
Reason for drug switch to rivaroxaban
Time frame: At baseline
Planned duration of anticoagulation with rivaroxaban
Time frame: At baseline
Actual duration of anticoagulation with rivaroxaban
Time frame: Up to 6 months
Dosage of rivaroxaban
Time frame: Up to 6 months
Reason for any potential dose adjustments during course of treatment with rivaroxaban
Time frame: Up to 6 months
Reasons for any switch from rivaroxaban treatment
Time frame: Up to 6 months
Reasons for permanent cessation of rivaroxaban treatment
Time frame: Up to 6 months
TNM Staging (Clinical characteristics of cancer disease)
Time frame: At baseline
Primary site of cancer (Clinical characteristics of cancer disease)
Time frame: At baseline
Type of bleeding events
Time frame: Up to 6 months
Number of bleeding events
Time frame: Up to 6 months
Type of thromboembolic events
Time frame: Up to 6 months
Number of thromboembolic events
Time frame: Up to 6 months
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 7 Nov 2023.
- Results publication: PubMed 34877446Maraveyas A, Beyer-Westendorf J, Lee AY, Mantovani LG, De Sanctis Y, Abdelgawwad K, Fatoba S, Bach M, Cohen AT. Cancer-Associated ThrOmboSIs - Patient-Reported OutcoMes With RivarOxaban (COSIMO) - Baseline characteristics and clinical outcomes. Res Pract Thromb Haemost. 2021 Nov 30;5(8):e12604. doi: 10.1002/rth2.12604. eCollection 2021 Dec.
- Derived from this study: PubMed 30186045Cohen AT, Maraveyas A, Beyer-Westendorf J, Lee AYY, Mantovani LG, Bach M; COSIMO Investigators. COSIMO - patients with active cancer changing to rivaroxaban for the treatment and prevention of recurrent venous thromboembolism: a non-interventional study. Thromb J. 2018 Sep 4;16:21. doi: 10.1186/s12959-018-0176-2. eCollection 2018.
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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.
Bayer Study Director study director
Bayer
10 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thrombosis and Pulmonary Embolism, run by Bayer at 10 sites in 10 countries.
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 6 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia, Belgium, Canada, Denmark, France and 5 more countries. 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?
Treatment satisfaction burden score (ACTS) (time frame: At 4 weeks). 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 NCT02742623, 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 7 Nov 2023.