Non-interventional Study on Patients With Atrial Fibrillation and Cancer

Cancer Clinical Trial

— BLITZ-AFCancer  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03909386
• Other study ID #: K21
• Status: Completed
• Start date: June 26, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2023
• Source: Heart Care Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1514
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cancer

Locations

Country	Name	City	State
Belgium	OLV ZIEKENHUIS AALST - Cardiology	Aalst
Belgium	AZ IMELDA - Cardiology	Bonheiden
Belgium	AZ ST-JAN - Cardiology	Brugge
Belgium	UZ Brussel - Cardiology	Brussel
Belgium	Hôpital Erasme - Cardiology	Brussels
Belgium	UCL Cliniques universitaires Saint-Luc - Cardiolgy	Brussels
Belgium	Ziekenhuis Oost-Limburg - Cardiology	Genk
Belgium	JESSA HASSELT - Cardiology	Hasselt
Belgium	AZ GROENINGE - Cardiology	Kortrijk
Belgium	UZ LEUVEN - Cardiovascular diseases	Leuven
Belgium	AZ DELTA ROESELARE - Cardiology	Roeselare
Belgium	AZ TURNHOUT - Cardiology	Turnhout
Ireland	Bon Secours Hospital Cork - Oncology Department	Cork
Ireland	Beacon Hospital, Cardiology	Dublin
Ireland	Tallaght University Hospital - Geriatric and Stroke Medicine Department	Dublin
Italy	Ospedale Miulli - U.O.C. Cardiologia - Utic	Acquaviva Delle Fonti
Italy	Ospedale San Giovanni Di Dio - Uo Cardiologia E Utic	Agrigento	AG
Italy	Ospedale Ss. Vito E Spirito - U.O.S. Di Cardiologia	Alcamo	TP
Italy	Ospedale San Donato - U.O. Cardiologia	Arezzo	AR
Italy	Nuovo Ospedale Dei Castelli - U.O.C. Di Cardiologia E Utic	Ariccia	RM
Italy	Ospedale Civile - U.O.C. Cardiologia	Arzignano	VI
Italy	Ospedale E. Muscatello - U.O. Di Cardiologia - Utic	Augusta	SR
Italy	Centro Di Riferimento Oncologico (Cro) - Cardiologia	Aviano	PN
Italy	Istituto Tumori Giovanni Paolo Ii - U.O. Di Cardiologia	Bari	BA
Italy	Ospedale San Paolo - Cardiologia-Utic	Bari	BA
Italy	Ospedale Civile - Sc Cardiologia	Belluno	BL
Italy	Ospedale Bellaria - U.O. Di Cardiologia	Bologna	BO
Italy	Ospedale Maggiore - U.O. Di Cardiologia	Bologna	BO
Italy	Ospedale Policlinico S. Orsola-Malpighi - U.O. Cardiologia-Rapezzi	Bologna	BO
Italy	Ospedale Ss. Trinita' - S.C. Di Cardiologia	Borgomanero
Italy	Ospedale A. Businco - Servizio Di Cardiologia	Cagliari	CA
Italy	Ospedale Roberto Binaghi - Servizio Di Cardiologia	Cagliari	CA
Italy	Ospedale Barone Lombardo - Cardiologia E Utic	Canicattì	AG
Italy	Ospedale Ramazzini - U.O. Cardiologia	Carpi	MO
Italy	Ospedale Santo Spirito - Sc Cardiologia	Casale Monferrato	AL
Italy	Az. Ospedaliera S. Anna E S. Sebastiano - Cardiologia Clinica Universitaria - Utic	Caserta	CE
Italy	Az. Ospedaliera S. Anna E S. Sebastiano - Uoc Medicina E Chirurgia D'Urgenza	Caserta
Italy	Ospedale Di Castellaneta - S.C. Cardiologia	Castellaneta	TA
Italy	Ospedale Civile Ferrari - U.O.C. Cardiologia-Utic	Castrovillari	CS
Italy	Azienda Ospedaliera Cannizzaro - Uoc Cardiologia Con Utic Ed Emodinamica	Catania	CT
Italy	Humanitas Centro Catanese Di Oncologia - Servizio Di Cardiologia	Catania	CT
Italy	P.O. Garibaldi-Nesima - U.O.C. Di Cardiologia	Catania	CT
Italy	Fondazione G. Giglio - U.O. Cardiologia E Utic	Cefalù	PA
Italy	Ospedale Policlinico Ss. Annunziata - Medicina Generale Ii	Chieti
Italy	Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia-Utic	Copertino	LE
Italy	Ospedale Civile San Giuseppe - Cardiologia	Empoli	FI
Italy	Ospedale Civile Profili - U.O. Cardiologia	Fabriano	AN
Italy	Ospedale Santa Maria Del Prato - U.O. Di Cardiologia	Feltre	BL
Italy	Arcispedale Sant'Anna - U.O. Cardiologia - Utic	Ferrara
Italy	Aou Careggi - Cardiologa Diagnostica	Firenze	FI
Italy	Aou Careggi - Diagnostica Cardiovascolare	Firenze	FI
Italy	Ospedale San Giovanni Di Dio - Cardiologia	Firenze	FI
Italy	Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic	Foggia	FG
Italy	Ospedale Padre Antero Micone - Sc Cardiologia - Utic	Genova	GE
Italy	Ospedale Policlinico San Martino - Clinica Malattie Cardiovascolari	Genova	GE
Italy	Ospedale Generale Di Zona - U.O. Cardiologia - Utic	Giugliano In Campania
Italy	Ospedale Civile - Sc Cardiologia Area Nord	Guastalla	RE
Italy	Nuovo Ospedale Versilia - Sc Cardiologia	Lido Di Camaiore	LU
Italy	Ospedale Civile M. Giannuzzi - Cardiologia E Utic	Manduria	TA
Italy	Presidio Ospedaliero Della Valle D'Itria - Struttura Complessa Di Cardiologia	Martina Franca	TA
Italy	Policlinico G. Martino - U.O. Medicina Interna	Messina	ME
Italy	Asst Ospedale Metropolitano Niguarda - Cardiologia 4 -Diagnost. E Riabilitativa	Milano	MI
Italy	Istituto Europeo Di Oncologia - Cardiologia	Milano	MI
Italy	Istituto Nazionale Tumori - Struttura Complessa Di Cardiologia	Milano	MI
Italy	Ospedale Civile - U.O. Cardiologia	Mirano	VE
Italy	Ospedale Regina Montis Regalis - U.O. Cardiologia-Utic	Mondovì	CN
Italy	Fondazione Pascale - S.C. Cardiologia	Napoli
Italy	Ospedale San Gennaro - U.O. Cardiologia E Riabilitazione Card.	Napoli
Italy	Ospedale Sacro Cuore - U.O. Di Cardiologia	Negrar	VR
Italy	Aou Maggiore Della Carita' - Cardiologia Ii	Novara
Italy	Ospedale San Francesco - Cardiologia - Utic	Nuoro	NU
Italy	Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia	Orbassano	TO
Italy	Istituto Oncologico Veneto - Cardiologia Oncologica	Padova	PD
Italy	Aor Villa Sofia-Cervello P.O. Cervello, Uo Cardiologia - Cervello	Palermo	PA
Italy	Ospedale Spoke Paola- Cetraro Po Paola - Utic Cardiologia	Paola	CS
Italy	Fondazione Irccs Policlinico San Matteo - Cardiologia	Pavia	PV
Italy	Ics Maugeri Spa Societa' Benefit - U.O. Di Riabilitazione Cardiologica	Pavia	PV
Italy	Presidio Ospedaliero San Salvatore - Cardiologia E Utic	Pesaro	PU
Italy	Ospedale Civile Dello Spirito Santo - Utic E Cardiologia Interventistica	Pescara	PE
Italy	Ospedale Ss. Cosma E Damiano - U. O. Cardiologia - Utic	Pescia
Italy	Ospedale Civile E. Agnelli - Sc Di Cardiologia	Pinerolo	TO
Italy	Azienda Ospedaliera Universitaria Pisana - U.O. Malattie Cardiovasc. I - Cisanello	Pisa	PI
Italy	Ospedale Dell'Alta Val D'Elsa - Uosd Cardiologia-Utic	Poggibonsi	SI
Italy	Ospedale Santa Maria Degli Ungheresi - Uoc Cardiologia-Utic	Polistena	RC
Italy	Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic	Pozzuoli
Italy	Ospedale Giovanni Paolo Ii - U.O.C. Cardiologia-Utic	Ragusa	RG
Italy	Ospedale Civile Santa Maria Delle Croci - U.O. Di Cardiologia	Ravenna	RA
Italy	Grande Ospedale Metropolitano-Bianchi Melacrino Morelli - Divisione Di Cardiologia	Reggio Calabria	RC
Italy	Arcispedale Santa Maria Nuova - S.C. Cardiologia	Reggio Emilia	RE
Italy	Ospedale G. Ceccarini - Cardiologia-Utic	Riccione	RN
Italy	Ospedale Degli Infermi, Sc Cardiologia	Rivoli	TO
Italy	Campus Biomedico - Cardiologia	Roma	RM
Italy	Ifo- Istituto Naz. Tumori Regina Elena - Uo Cardiologia	Roma	RM
Italy	Ospedale San Camillo - Uosd Servizi Cardiologici Integrati	Roma	RM
Italy	Ospedale Sandro Pertini, Uoc Cardiologia	Roma
Italy	P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic	Roma	RM
Italy	Policlinico Agostino Gemelli - Uo Cardiologia Per Sc E Riab. Cardiolog.	Roma	RM
Italy	Ospedale Santa Maria Del Carmine - Cardiologia	Rovereto	TN
Italy	Aou S. Giovanni Di Dio-Ruggi D'Aragona - Cardiologia Intensiva	Salerno	SA
Italy	Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic	Santa Maria Capua Vetere	CE
Italy	Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia	Saronno	VA
Italy	Ospedale San Bartolomeo - U.O. Cardiologia Clinica-Riabilitativa	Sarzana	SP
Italy	Ospedale Di Sassuolo - Cardiologia	Sassuolo	MO
Italy	Ospedale Maggiore Ss. Annunziata - Sc Cardiologia	Savigliano	CN
Italy	Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic	Scorrano	LE
Italy	Ospedale Civile G. Mazzini - Cardiologia Utic Ed Emodinamica	Teramo	TE
Italy	Azienda Ospedaliera Santa Maria - S.C. Di Cardiologia	Terni	TR
Italy	Aou Citta' Della Salute E Della Scienza - S.C.D.U. Cardiologia	Torino	TO
Italy	Ospedale Giovanni Bosco - Sc Cardiologia	Torino	TO
Italy	Ospedale Humanitas Gradenigo - Cardiologia	Torino	TO
Italy	Ospedale Mauriziano Umberto I - Sc Cardiologia	Torino	TO
Italy	Ospedali Treviglio-Caravaggio - Cardiologia	Treviglio	BG
Italy	Asui Trieste - S.C. Centro Cardiovascolare	Trieste	TS
Italy	Pou Santa Maria Della Misericordia - S.O.C. Cardiologia	Udine	UD
Italy	Ospedale Di Vizzolo Predabissi - Uo Cardiologia E Ucc	Vizzolo Predabissi	MI
Netherlands	Rijnstate Ziekenhuis - Afdeling Cardioresearch	Arnhem
Netherlands	Tergooi - Poli cardiologie / poli 2	Blaricum
Netherlands	Amphia Ziekenhuis - Research Cardiologie	Breda
Netherlands	Jeroen Bosch Ziekenhuis - Research Cardiologie	Den Bosch
Netherlands	Martini Ziekenhuis - Dept. Cardio Research Noord BV	Groningen
Netherlands	Diakonessenhuis - Research Cardiologie	Utrecht
Netherlands	University Medical Center Utrecht - Cardiologie	Utrecht
Netherlands	Máxima Medisch Centrum - Poli Cardiologie	Veldhoven
Portugal	Prof. Doutor Fernando Fonseca EPE Hospital, Cardiologia	Amadora
Portugal	Hospital Nossa Senhora do Rosário, Cardiology	Barreiro
Portugal	Hospital da Luz	Lisboa
Portugal	Hospital de Santa Cruz, Cardiology	Lisboa
Portugal	Hospital Santa Maria, Cardiology	Lisboa
Spain	Hospital del Mar (Parc de Salut Mar),Cardiologa I Unitat Coronaria	Barcelona
Spain	Hospital Médico-Quirúrgico, Cardiology	Jaén
Spain	Clínica Anderson, Oncología Médica	Madrid
Spain	Clínica Medicentro, Cardiología	Madrid
Spain	Hopsital Puerta de Hierro	Madrid
Spain	Hospital La Moraleja, Servicio de Cardiología	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital La Zarzuela	Madrid
Spain	Hospital Montepríncipe, Cardiología	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Rúber Internacional, Oncología	Madrid
Spain	Hospital Universitario Gregorio Marañón, Servicio de Cardiología	Madrid
Spain	Hospital Virgen de Arrixaca - Cardiologia	Murcia
Spain	Hospital de Salamanca, Cardiología	Salamanca
Spain	Hospital Universitario Virgen Macarena, Cardiologia	Sevilla
Spain	Hospital de Torrejón	Torrejón De Ardoz
Spain	Hospital Universitario Río Hortega, Cardiología	Valladolid
Spain	University Clinical Hosp. de Valladolid, Cardiología	Valladolid
Spain	Hospital Clínico "Lozano Blesa", Cardiologia	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Heart Care Foundation

Countries where clinical trial is conducted

Belgium,  Ireland,  Italy,  Netherlands,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Primary	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	12 Months
Secondary	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	Baseline and 12 months
Secondary	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	Baseline and 12 months
Secondary	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)	Baseline and 12 months
Secondary	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	Baseline and 12 months
Secondary	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	Baseline and 12 months
Secondary	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	Baseline and 12 months
Secondary	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	Baseline and 12 months
Secondary	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	Baseline and 12 months
Secondary	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	Baseline and 12 months
Secondary	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	Baseline and 12 months
Secondary	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	Baseline and 12 months
Secondary	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	Baseline and 12 months
Secondary	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	Baseline and 12 months
Secondary	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	Baseline and 12 months
Secondary	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	Baseline and 12 months
Secondary	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	Baseline and 12 months
Secondary	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;	Baseline and 12 months
Secondary	Treatment satisfaction	Treatment satisfaction as assessed by the Perception Anticoagulant Treatment Questionnaire (PACT-Q)	Baseline and 12 months
Secondary	Quality of life satisfaction	Health related quality of life as assessed by the EuroQol (EQ-5D-5L) questionnaire	Baseline and 12 months