Atrial Fibrillation, Cancer
Conditions
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.
Interventions
None listed
Sponsors
Heart Care Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy | Baseline | Number of patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing transient ischemic attacks | Baseline and 12 months | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing transient ischemic attacks |
| 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 | 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) |
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing systemic embolic events | Baseline and 12 months | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing systemic embolic events |
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing acute coronary syndrome | Baseline and 12 months | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing acute coronary syndrome |
| 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 | 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 |
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing deep vein thrombosis | Baseline and 12 months | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing deep vein thrombosis |
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing pulmonary embolism | Baseline and 12 months | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing pulmonary embolism |
| 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 | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major bleeding (Fatal bleeding, Non-fatal bleeding,Intracranial hemorrhage |
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all cause stroke | Baseline and 12 months | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all cause stroke |
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing composite of major and CRNM bleeding | Baseline and 12 months | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing composite of major and CRNM bleeding |
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all-cause death | Baseline and 12 months | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all-cause death |
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing cardiovascular death | Baseline and 12 months | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing cardiovascular death |
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing death due to malignancy | Baseline and 12 months | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing death due to malignancy |
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing sudden and unexplained death | Baseline and 12 months | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing sudden and unexplained death |
| Association of various antithrombotic treatments (or lack of) on hospital admissions due to CV or non CV causes | Baseline and 12 months | Number of hospital admissions (defined as ≥ 24 h stay in a hospital) due to CV or non CV causes |
| Treatment satisfaction | Baseline and 12 months | Treatment satisfaction as assessed by the Perception Anticoagulant Treatment Questionnaire (PACT-Q) |
| Quality of life satisfaction | Baseline and 12 months | Health related quality of life as assessed by the EuroQol (EQ-5D-5L) questionnaire |
| Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing clinically relevant non-major bleeding | Baseline and 12 months | Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing clinically relevant non-major bleeding |
Countries
Belgium, Ireland, Italy, Netherlands, Portugal, Spain
Outcome results
None listed