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

Completed

• Conditions: Venous Thrombosis and Pulmonary Embolism
• Interventions: Drug: Rivaroxaban (Xarelto, BAY 59-7939)

• Registration Number: NCT02742623
• Lead Sponsor: Bayer

Brief Summary

This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-19
• Study Start: 2016-10-11
• Primary Completion: 2018-11-30
• Study Completion: 2019-03-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 528

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban (Xarelto, BAY 59-7939)	Female and male patients with active cancer and treated with rivaroxaban after a diagnosis of DVT/ and/or PE

Primary Outcome Measures

Name	Time	Method
Treatment satisfaction burden score (ACTS)	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.

Secondary Outcome Measures

Name	Time	Method
Type of index VTE (venous thromboembolism) event	At baseline
Preferences regarding the attributes of the anticoagulation medication options LMWH, VKA, rivaroxaban using DCE survey	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
Change of ACTS score over time	At 3 months and 6 months	To assess patient reported outcomes by means of the Anti-Clot Treatment Scale (ACTS) questionnaire
Patient's quality of life using the FACIT-Fatigue questionnaire	Up to 6 months	To assess patient reported outcomes on quality of life using the FACIT-Fatigue questionnaire (Functional Assessment of Chronic Illness Therapy)
Type (trade name) of initial anticoagulation treatment	At baseline
Date of index VTE event	At baseline
Duration of initial anticoagulation treatment	At baseline
Reason for drug switch to rivaroxaban	At baseline	Menu items: patient choice, physician choice, side effects, other
Planned duration of anticoagulation with rivaroxaban	At baseline
Actual duration of anticoagulation with rivaroxaban	Up to 6 months
Dosage of rivaroxaban	Up to 6 months
Reason for any potential dose adjustments during course of treatment with rivaroxaban	Up to 6 months	Menu items: side effects, intervention, other
Reasons for any switch from rivaroxaban treatment	Up to 6 months	Menu items: patient choice, physician choice, side effects, other
Reasons for permanent cessation of rivaroxaban treatment	Up to 6 months	Menu items: patient choice, physician choice, side effects, other
TNM Staging (Clinical characteristics of cancer disease)	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)
Primary site of cancer (Clinical characteristics of cancer disease)	At baseline	Following Medical Dictionary for Regulatory Activities (MedDRA) coding system
Type of bleeding events	Up to 6 months
Number of bleeding events	Up to 6 months
Type of thromboembolic events	Up to 6 months
Number of thromboembolic events	Up to 6 months