Clincosm LogoSign in Get a demo

BLITZ-AFCancer: Non-interventional Study on Patients With Atrial Fibrillation and Cancer

Sponsor
Heart Care Foundation (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03909386
Collaborator
(none)
1,514
Enrollment
119
Locations
39.2
Anticipated Duration (Months)
12.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    1514 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multicenter, Non-interventional Study on Patients With Atrial Fibrillation (AF) and Cancer (Diagnosed Within the Last 3 Years Prior to Enrolment)
    Actual Study Start Date :
    Jun 26, 2019
    Actual Primary Completion Date :
    Sep 30, 2021
    Anticipated Study Completion Date :
    Sep 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    1. 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

    2. 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

    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) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Baseline and 12 months]

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

    19. Quality of life satisfaction [Baseline and 12 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 OLV ZIEKENHUIS AALST - Cardiology Aalst Belgium
    2 AZ IMELDA - Cardiology Bonheiden Belgium
    3 AZ ST-JAN - Cardiology Brugge Belgium
    4 UZ Brussel - Cardiology Brussel Belgium
    5 Ziekenhuis Oost-Limburg - Cardiology Genk Belgium
    6 JESSA HASSELT - Cardiology Hasselt Belgium
    7 AZ GROENINGE - Cardiology Kortrijk Belgium
    8 UZ LEUVEN - Cardiovascular diseases Leuven Belgium
    9 AZ DELTA ROESELARE - Cardiology Roeselare Belgium
    10 Beacon Hospital, Cardiology Dublin Ireland
    11 Tallaght University Hospital - Geriatric and Stroke Medicine Department Dublin Ireland
    12 Ospedale San Giovanni Di Dio - Uo Cardiologia E Utic Agrigento AG Italy 92100
    13 Ospedale Barone Lombardo - Cardiologia E Utic Canicattì AG Italy 92024
    14 Ospedale Santo Spirito - Sc Cardiologia Casale Monferrato AL Italy 15033
    15 Ospedale Civile Profili - U.O. Cardiologia Fabriano AN Italy 60044
    16 Ospedale San Paolo - Cardiologia-Utic Bari BA Italy 70123
    17 Istituto Tumori Giovanni Paolo Ii - U.O. Di Cardiologia Bari BA Italy 70124
    18 Ospedali Treviglio-Caravaggio - Cardiologia Treviglio BG Italy 24047
    19 Ospedale Civile - Sc Cardiologia Belluno BL Italy 32100
    20 Ospedale Santa Maria Del Prato - U.O. Di Cardiologia Feltre BL Italy 32032
    21 Ospedale Maggiore - U.O. Di Cardiologia Bologna BO Italy 40133
    22 Ospedale Policlinico S. Orsola-Malpighi - U.O. Cardiologia-Rapezzi Bologna BO Italy 40138
    23 Ospedale Bellaria - U.O. Di Cardiologia Bologna BO Italy 40139
    24 Ospedale A. Businco - Servizio Di Cardiologia Cagliari CA Italy 09121
    25 Ospedale Roberto Binaghi - Servizio Di Cardiologia Cagliari CA Italy 09126
    26 Az. Ospedaliera S. Anna E S. Sebastiano - Cardiologia Clinica Universitaria - Utic Caserta CE Italy 81100
    27 Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic Santa Maria Capua Vetere CE Italy 81055
    28 Ospedale Regina Montis Regalis - U.O. Cardiologia-Utic Mondovì CN Italy 12084
    29 Ospedale Maggiore Ss. Annunziata - Sc Cardiologia Savigliano CN Italy 12038
    30 Ospedale Civile Ferrari - U.O.C. Cardiologia-Utic Castrovillari CS Italy 87012
    31 Ospedale Spoke Paola- Cetraro Po Paola - Utic Cardiologia Paola CS Italy 87027
    32 P.O. Garibaldi-Nesima - U.O.C. Di Cardiologia Catania CT Italy 95122
    33 Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic Foggia FG Italy 71100
    34 Ospedale Civile San Giuseppe - Cardiologia Empoli FI Italy 50053
    35 Ospedale San Giovanni Di Dio - Cardiologia Firenze FI Italy 50124
    36 Aou Careggi - Cardiologa Diagnostica Firenze FI Italy 50134
    37 Aou Careggi - Diagnostica Cardiovascolare Firenze FI Italy 50139
    38 Ospedale Policlinico San Martino - Clinica Malattie Cardiovascolari Genova GE Italy 16132
    39 Ospedale Padre Antero Micone - Sc Cardiologia - Utic Genova GE Italy 16153
    40 Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia-Utic Copertino LE Italy 73043
    41 Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic Scorrano LE Italy 73020
    42 Nuovo Ospedale Versilia - Sc Cardiologia Lido Di Camaiore LU Italy 55043
    43 Policlinico G. Martino - U.O. Medicina Interna Messina ME Italy 98124
    44 Istituto Nazionale Tumori - Struttura Complessa Di Cardiologia Milano MI Italy 20133
    45 Istituto Europeo Di Oncologia - Cardiologia Milano MI Italy 20141
    46 Asst Ospedale Metropolitano Niguarda - Cardiologia 4 -Diagnost. E Riabilitativa Milano MI Italy 20162
    47 Ospedale Di Vizzolo Predabissi - Uo Cardiologia E Ucc Vizzolo Predabissi MI Italy 20077
    48 Ospedale Di Sassuolo - Cardiologia Sassuolo MO Italy 41049
    49 Ospedale San Francesco - Cardiologia - Utic Nuoro NU Italy 08100
    50 Fondazione G. Giglio - U.O. Cardiologia E Utic Cefalù PA Italy 90015
    51 Aor Villa Sofia-Cervello P.O. Cervello, Uo Cardiologia - Cervello Palermo PA Italy 90146
    52 Istituto Oncologico Veneto - Cardiologia Oncologica Padova PD Italy 35128
    53 Ospedale Civile Dello Spirito Santo - Utic E Cardiologia Interventistica Pescara PE Italy 65124
    54 Centro Di Riferimento Oncologico (Cro) - Cardiologia Aviano PN Italy 33081
    55 Presidio Ospedaliero San Salvatore - Cardiologia E Utic Pesaro PU Italy 61121
    56 Fondazione Irccs Policlinico San Matteo - Cardiologia Pavia PV Italy 27100
    57 Ics Maugeri Spa Societa' Benefit - U.O. Di Riabilitazione Cardiologica Pavia PV Italy 27100
    58 Ospedale Santa Maria Degli Ungheresi - Uoc Cardiologia-Utic Polistena RC Italy 89024
    59 Grande Ospedale Metropolitano-Bianchi Melacrino Morelli - Divisione Di Cardiologia Reggio Calabria RC Italy 89124
    60 Ospedale Civile - Sc Cardiologia Area Nord Guastalla RE Italy 42016
    61 Arcispedale Santa Maria Nuova - S.C. Cardiologia Reggio Emilia RE Italy 42100
    62 Ospedale Giovanni Paolo Ii - U.O.C. Cardiologia-Utic Ragusa RG Italy 97100
    63 Nuovo Ospedale Dei Castelli - U.O.C. Di Cardiologia E Utic Ariccia RM Italy 00072
    64 P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic Roma RM Italy 00135
    65 Ospedale San Camillo - Uosd Servizi Cardiologici Integrati Roma RM Italy 00151
    66 Ifo- Istituto Naz. Tumori Regina Elena - Uo Cardiologia Roma RM Italy 00152
    67 Ospedale G. Ceccarini - Cardiologia-Utic Riccione RN Italy 47838
    68 Ospedale Dell'Alta Val D'Elsa - Uosd Cardiologia-Utic Poggibonsi SI Italy 53036
    69 Ospedale San Bartolomeo - U.O. Cardiologia Clinica-Riabilitativa Sarzana SP Italy 19038
    70 Ospedale Di Castellaneta - S.C. Cardiologia Castellaneta TA Italy 74011
    71 Ospedale Civile M. Giannuzzi - Cardiologia E Utic Manduria TA Italy 74024
    72 Presidio Ospedaliero Della Valle D'Itria - Struttura Complessa Di Cardiologia Martina Franca TA Italy 74015
    73 Ospedale Civile G. Mazzini - Cardiologia Utic Ed Emodinamica Teramo TE Italy 64100
    74 Ospedale Santa Maria Del Carmine - Cardiologia Rovereto TN Italy 38068
    75 Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia Orbassano TO Italy 10043
    76 Ospedale Degli Infermi, Sc Cardiologia Rivoli TO Italy
    77 Aou Citta' Della Salute E Della Scienza - S.C.D.U. Cardiologia Torino TO Italy 10126
    78 Ospedale Mauriziano Umberto I - Sc Cardiologia Torino TO Italy 10128
    79 Ospedale Humanitas Gradenigo - Cardiologia Torino TO Italy 10153
    80 Ospedale Giovanni Bosco - Sc Cardiologia Torino TO Italy 10155
    81 Azienda Ospedaliera Santa Maria - S.C. Di Cardiologia Terni TR Italy 05100
    82 Asui Trieste - S.C. Centro Cardiovascolare Trieste TS Italy 34125
    83 Pou Santa Maria Della Misericordia - S.O.C. Cardiologia Udine UD Italy 33100
    84 Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia Saronno VA Italy 21047
    85 Ospedale Civile - U.O. Cardiologia Mirano VE Italy 30035
    86 Ospedale Civile - U.O.C. Cardiologia Arzignano VI Italy 36071
    87 Ospedale Miulli - U.O.C. Cardiologia - Utic Acquaviva Delle Fonti Italy
    88 Ospedale Ss. Trinita' - S.C. Di Cardiologia Borgomanero Italy 28021
    89 Ospedale Policlinico Ss. Annunziata - Medicina Generale Ii Chieti Italy
    90 Arcispedale Sant'Anna - U.O. Cardiologia - Utic Ferrara Italy
    91 Ospedale Generale Di Zona - U.O. Cardiologia - Utic Giugliano In Campania Italy 80014
    92 Fondazione Pascale - S.C. Cardiologia Napoli Italy 80131
    93 Aou Maggiore Della Carita' - Cardiologia Ii Novara Italy 28100
    94 Ospedale Ss. Cosma E Damiano - U. O. Cardiologia - Utic Pescia Italy
    95 Ospedale Sandro Pertini, Uoc Cardiologia Roma Italy
    96 Rijnstate Ziekenhuis - Afdeling Cardioresearch Arnhem Netherlands
    97 Tergooi - Poli cardiologie / poli 2 Blaricum Netherlands
    98 Amphia Ziekenhuis - Research Cardiologie Breda Netherlands
    99 Jeroen Bosch Ziekenhuis - Research Cardiologie Den Bosch Netherlands
    100 Martini Ziekenhuis - Dept. Cardio Research Noord BV Groningen Netherlands
    101 Diakonessenhuis - Research Cardiologie Utrecht Netherlands
    102 University Medical Center Utrecht - Cardiologie Utrecht Netherlands
    103 Máxima Medisch Centrum - Poli Cardiologie Veldhoven Netherlands
    104 Prof. Doutor Fernando Fonseca EPE Hospital, Cardiologia Amadora Portugal
    105 Hospital Nossa Senhora do Rosário, Cardiology Barreiro Portugal
    106 Hospital da Luz Lisboa Portugal
    107 Hospital de Santa Cruz, Cardiology Lisboa Portugal
    108 Hospital Santa Maria, Cardiology Lisboa Portugal
    109 Hospital del Mar (Parc de Salut Mar),Cardiologa I Unitat Coronaria Barcelona Spain
    110 Clínica Anderson, Oncología Médica Madrid Spain
    111 Clínica Medicentro, Cardiología Madrid Spain
    112 Hopsital Puerta de Hierro Madrid Spain
    113 Hospital La Zarzuela Madrid Spain
    114 Hospital Ramón y Cajal Madrid Spain
    115 Hospital de Salamanca, Cardiología Salamanca Spain
    116 Hospital Universitario Virgen Macarena, Cardiologia Sevilla Spain
    117 Hospital de Torrejón Torrejón De Ardoz Spain
    118 University Clinical Hosp. de Valladolid, Cardiología Valladolid Spain
    119 Hospital Clínico "Lozano Blesa", Cardiologia Zaragoza Spain

    Sponsors and Collaborators

    • Heart Care Foundation

    Investigators

    • Study Chair: Michele M Gulizia, MD, Heart Care Foundation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heart Care Foundation
    ClinicalTrials.gov Identifier:
    NCT03909386
    Other Study ID Numbers:
    • K21
    First Posted:
    Apr 10, 2019
    Last Update Posted:
    Mar 16, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Mar 16, 2022