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Completed

NCT Number: NCT03909386

Non-interventional Study on Patients With Atrial Fibrillation and Cancer

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cancer Cardiovascular Diseases Heart Diseases Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OLV ZIEKENHUIS AALST - Cardiology, Aalst, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy

    Time frame: Baseline

    Number of patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy

  2. Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy

    Time frame: 12 Months

    Number of patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy

Secondary outcomes

  1. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all cause stroke

    Time frame: Baseline and 12 months

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all cause stroke

  2. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing transient ischemic attacks

    Time frame: Baseline and 12 months

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing transient ischemic attacks

  3. 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

    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)

  4. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing systemic embolic events

    Time frame: Baseline and 12 months

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing systemic embolic events

  5. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing acute coronary syndrome

    Time frame: Baseline and 12 months

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing acute coronary syndrome

  6. 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

    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

  7. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing deep vein thrombosis

    Time frame: Baseline and 12 months

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing deep vein thrombosis

  8. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing pulmonary embolism

    Time frame: Baseline and 12 months

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing pulmonary embolism

  9. 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

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major bleeding (Fatal bleeding, Non-fatal bleeding,Intracranial hemorrhage

  10. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing clinically relevant non-major bleeding

    Time frame: Baseline and 12 months

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing clinically relevant non-major bleeding

  11. 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

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing composite of major and CRNM bleeding

  12. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all-cause death

    Time frame: Baseline and 12 months

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all-cause death

  13. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing cardiovascular death

    Time frame: Baseline and 12 months

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing cardiovascular death

  14. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing death due to malignancy

    Time frame: Baseline and 12 months

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing death due to malignancy

  15. Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing sudden and unexplained death

    Time frame: Baseline and 12 months

    Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing sudden and unexplained death

  16. Association of various antithrombotic treatments (or lack of) on hospital admissions due to CV or non CV causes

    Time frame: Baseline and 12 months

    Number of hospital admissions (defined as ≥ 24 h stay in a hospital) due to CV or non CV causes

  17. Association of various antithrombotic treatments (or lack of) on hospital admissions due to CV or non CV causes

    Time frame: Baseline and 12 months

    Length of hospital admissions (defined as ≥ 24 h stay in a hospital) due to CV or non CV causes;

  18. Treatment satisfaction

    Time frame: Baseline and 12 months

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

  19. Quality of life satisfaction

    Time frame: Baseline and 12 months

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

Sponsors and collaborators

Lead sponsor

Heart Care Foundation

Other

Registry information

Official study title

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

Acronym: BLITZ-AFCancer

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 10, 2019
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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