Non-interventional Study on Patients With Atrial Fibrillation and Cancer

Study Overview
=================
Brief Summary
-----------------
AF and cancer frequently coexist. Since these patients are usually excluded from randomized trials, information on their management and outcome is scarce. Occurrence of relevant clinical events, such as ischemic and hemorrhagic and all-cause mortality and cardiovascular (CV) mortality occurring in patients treated or not with antithrombotic agents needs to be clarified. A prospective observational registry collecting information, in a real world setting, on the clinical profile of patients with these clinical conditions and on the use of antithrombotic drugs in patients with AF and cancer could improve our knowledge on the management of these high risk patients.

Detailed Description
-----------------
International, multicenter, non-interventional study on patients with atrial fibrillation (AF) and cancer (diagnosed within the last 3 years prior to enrolment). The study will be conducted in about 80 sites in italy and 50 sites distributed in other European countries (Belgium, Germany, Ireland, Portugal, Spain, The Netherlands, Turkey). The study will continue till the consecutive recruitment of 1500 patients. The recruitment period will last approximately 24 months. Number of visits per patient: Baseline and 1 year (Final). Physicians will not be required to perform any additional tests, assessments, etc., not in line with their routine medical practice.

Official Title
-----------------
Multicenter, Non-interventional Study on Patients With Atrial Fibrillation (AF) and Cancer (Diagnosed Within the Last 3 Years Prior to Enrolment)

Conditions
-----------------
Atrial Fibrillation, Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both sexes Age >18 years Patient with diagnosed AF (any type of AF, electrocardiographically documented within 1 year prior to enrolment) Patient with a documented cancer (diagnosed within the last 3 years prior to enrolment into this registry), including melanoma but not other basal-cell or squamous-cell carcinoma of the skin. The diagnosis/history of cancer must be objectively documented. Written informed consent (IC) for participation in the study Patient not simultaneously participating in any interventional study. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy | Number of patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy | Baseline | 
| Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy | Number of patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all cause stroke | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all cause stroke | Baseline and 12 months | 
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing transient ischemic attacks | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing transient ischemic attacks | Baseline and 12 months | 
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major adverse cardiovascular events (non fatal MI, non fatal stroke, non fatal systemic embolic events, cardiovascular death) | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major adverse cardiovascular events (non fatal MI, non fatal stroke, non fatal systemic embolic events, cardiovascular death) | Baseline and 12 months | 
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing systemic embolic events | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing systemic embolic events | Baseline and 12 months | 
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing acute coronary syndrome | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing acute coronary syndrome | Baseline and 12 months | 
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing venous thromboembolic events, defined as composite of deep vein thrombosis and pulmonary embolism | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing venous thromboembolic events, defined as composite of deep vein thrombosis and pulmonary embolism | Baseline and 12 months | 
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing deep vein thrombosis | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing deep vein thrombosis | Baseline and 12 months | 
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing pulmonary embolism | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing pulmonary embolism | Baseline and 12 months | 
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major bleeding (Fatal bleeding, Non-fatal bleeding,Intracranial hemorrhage | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major bleeding (Fatal bleeding, Non-fatal bleeding,Intracranial hemorrhage | Baseline and 12 months | 
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing clinically relevant non-major bleeding | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing clinically relevant non-major bleeding | Baseline and 12 months | 
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing composite of major and CRNM bleeding | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing composite of major and CRNM bleeding | Baseline and 12 months | 
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all-cause death | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all-cause death | Baseline and 12 months | 
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing cardiovascular death | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing cardiovascular death | Baseline and 12 months | 
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing death due to malignancy | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing death due to malignancy | Baseline and 12 months | 
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing sudden and unexplained death | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing sudden and unexplained death | Baseline and 12 months | 
| Association of various antithrombotic treatments (or lack of) on hospital admissions due to CV or non CV causes | Number of hospital admissions (defined as ≥ 24 h stay in a hospital) due to CV or non CV causes | Baseline and 12 months | 
| Association of various antithrombotic treatments (or lack of) on hospital admissions due to CV or non CV causes | Length of hospital admissions (defined as ≥ 24 h stay in a hospital) due to CV or non CV causes; | Baseline and 12 months | 
| Treatment satisfaction | Treatment satisfaction as assessed by the Perception Anticoagulant Treatment Questionnaire (PACT-Q) | Baseline and 12 months | 
| Quality of life satisfaction | Health related quality of life as assessed by the EuroQol (EQ-5D-5L) questionnaire | Baseline and 12 months |