NCT03909386 - Non-interventional Study on Patients With Atrial Fibrillation and Cancer | Crick | Crick

Non-interventional Study on Patients With Atrial Fibrillation and Cancer

N/ACompletedNCT03909386

Heart Care Foundation1,514 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,514

Conditions

Atrial Fibrillation Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: \-

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 12 Months

Secondary Outcomes

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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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;

Time frame: Baseline and 12 months

Treatment satisfaction

Treatment satisfaction as assessed by the Perception Anticoagulant Treatment Questionnaire (PACT-Q)

Time frame: Baseline and 12 months

Quality of life satisfaction

Health related quality of life as assessed by the EuroQol (EQ-5D-5L) questionnaire

Time frame: Baseline and 12 months