Non-interventional Study on Patients With Atrial Fibrillation and Cancer

Completed

• Conditions: Cancer; Atrial Fibrillation

• Registration Number: NCT03909386
• Lead Sponsor: Heart Care Foundation

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.

Study Timeline

• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-10
• Study Start: 2019-06-26
• Primary Completion: 2021-09-30
• Study Completion: 2022-09-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1514

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy	12 Months	Number of patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy

Secondary Outcome Measures

Name	Time	Method
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 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 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
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 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 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 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
Association of various antithrombotic treatments (or lack of) on hospital admissions due to CV or non CV causes	Baseline and 12 months	Length of hospital admissions (defined as ≥ 24 h stay in a hospital) due to CV or non CV causes;
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 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
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

Trial Locations

Locations (147)

OLV ZIEKENHUIS AALST - Cardiology; 🇧🇪 Aalst, Belgium

AZ IMELDA - Cardiology; 🇧🇪 Bonheiden, Belgium

AZ ST-JAN - Cardiology; 🇧🇪 Brugge, Belgium

Hôpital Erasme - Cardiology; 🇧🇪 Brussels, Belgium

UCL Cliniques universitaires Saint-Luc - Cardiolgy; 🇧🇪 Brussels, Belgium

UZ Brussel - Cardiology; 🇧🇪 Brussel, Belgium

Ziekenhuis Oost-Limburg - Cardiology; 🇧🇪 Genk, Belgium

JESSA HASSELT - Cardiology; 🇧🇪 Hasselt, Belgium

AZ GROENINGE - Cardiology; 🇧🇪 Kortrijk, Belgium

UZ LEUVEN - Cardiovascular diseases; 🇧🇪 Leuven, Belgium

Scroll for more (137 remaining)