A Non-interventional Study on Xarelto for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer
NCT ID: NCT02742623
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
528 participants
OBSERVATIONAL
2016-10-11
2019-03-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort
NCT04979780
Characterizing Recurrent Thromboembolism, Major Bleeding and All-Cause Death in Patients With Cancer-Associated Thromboembolism Treated With Rivaroxaban
NCT03214172
A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants
NCT02555878
Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy
NCT01619007
Xarelto Regulatory Post-Marketing Surveillance
NCT01029743
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rivaroxaban
Female and male patients with active cancer and treated with rivaroxaban after a diagnosis of DVT/ and/or PE
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Research & Development, LLC
INDUSTRY
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Multiple Locations, , Australia
Multiple Locations, , Belgium
Multiple Locations, , Canada
Multiple Locations, , Denmark
Multiple Locations, , France
Multiple Locations, , Germany
Multiple Locations, , Italy
Multiple Locations, , Netherlands
Multiple Locations, , Spain
Multiple Locations, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Cohen 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.
Related Links
Access external resources that provide additional context or updates about the study.
Click here to find further information and, after study completion, the study results according to Bayer's transparency standards
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
XA1502
Identifier Type: OTHER
Identifier Source: secondary_id
18137
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.