A Non-interventional Study on Xarelto for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer (COSIMO)

November 3, 2023 updated by: Bayer

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

528

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female and male patients with active cancer and a diagnosis of DVT/ and/or PE after the decision for treatment with rivaroxaban

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rivaroxaban
Female and male patients with active cancer and treated with rivaroxaban after a diagnosis of DVT/ and/or PE
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preferences regarding the attributes of the anticoagulation medication options LMWH, VKA, rivaroxaban using DCE survey
Time Frame: Between 4 weeks and 3 months

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
Between 4 weeks and 3 months
Change of ACTS score over time
Time Frame: At 3 months and 6 months
To assess patient reported outcomes by means of the Anti-Clot Treatment Scale (ACTS) questionnaire
At 3 months and 6 months
Patient's quality of life using the FACIT-Fatigue questionnaire
Time Frame: Up to 6 months
To assess patient reported outcomes on quality of life using the FACIT-Fatigue questionnaire (Functional Assessment of Chronic Illness Therapy)
Up to 6 months
Type of index VTE (venous thromboembolism) event
Time Frame: At baseline
At baseline
Date of index VTE event
Time Frame: At baseline
At baseline
Type (trade name) of initial anticoagulation treatment
Time Frame: At baseline
At baseline
Duration of initial anticoagulation treatment
Time Frame: At baseline
At baseline
Reason for drug switch to rivaroxaban
Time Frame: At baseline
Menu items: patient choice, physician choice, side effects, other
At baseline
Planned duration of anticoagulation with rivaroxaban
Time Frame: At baseline
At baseline
Actual duration of anticoagulation with rivaroxaban
Time Frame: Up to 6 months
Up to 6 months
Dosage of rivaroxaban
Time Frame: Up to 6 months
Up to 6 months
Reason for any potential dose adjustments during course of treatment with rivaroxaban
Time Frame: Up to 6 months
Menu items: side effects, intervention, other
Up to 6 months
Reasons for any switch from rivaroxaban treatment
Time Frame: Up to 6 months
Menu items: patient choice, physician choice, side effects, other
Up to 6 months
Reasons for permanent cessation of rivaroxaban treatment
Time Frame: Up to 6 months
Menu items: patient choice, physician choice, side effects, other
Up to 6 months
TNM Staging (Clinical characteristics of cancer disease)
Time Frame: At baseline
Assessment according to TNM (Tumor, Lymph Node and Metastases) classification. TNM is developed and maintained by the Union for International Cancer Control (UICC)
At baseline
Primary site of cancer (Clinical characteristics of cancer disease)
Time Frame: At baseline
Following Medical Dictionary for Regulatory Activities (MedDRA) coding system
At baseline
Type of bleeding events
Time Frame: Up to 6 months
Up to 6 months
Number of bleeding events
Time Frame: Up to 6 months
Up to 6 months
Type of thromboembolic events
Time Frame: Up to 6 months
Up to 6 months
Number of thromboembolic events
Time Frame: Up to 6 months
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

Investigators

  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2016

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

March 28, 2019

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimated)

April 19, 2016

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18137
  • XA1502 (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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