Clinical trial NCT03656523: Management of Antithrombotic TherApy in Patients With Atrial Fibrillation or DevelOping AtRial Fibrillation During Hospitalization for PCI
Official title: Management of Antithrombotic TherApy in Patients With Atrial Fibrillation or DevelOping AtRial Fibrillation During Hospitalization for PCI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Atrial Fibrillation
Keywords: Acute Coronary Syndrome
Atrial Fibrillation
Percutaneous Coronary Intervention
Lead sponsor: Heart Care Foundation
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 598
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ACS trated with PCI with stent implantation developing or having Atrial Fibrillation.

Brief summary: ACS are a potent risk factor for AF, with new onset AF occurring in up to 1 in every 5 patients hospitalized with an ACS.

Despite its relatively frequent occurrence and the many etiologic factors involved in its pathogenetic condition, the frequency and prognostic significance of AF complicating ACS remain unclear

Detailed description: There are limited data available, particularly from a representative population-based perspective describing recent pharmacological and non-pharmacological management and clinical event rates associated with AF complicating ACS in the era of novel treatment strategies (in both AF and ACS) and high coronary reperfusion rates.

This registry will assess the current in-hospital management and clinical events at 6 months of consecutive patients admitted in Italian cardiology intensive care units (CCUs) for an ACS treated invasively with PCI and stent implantation who present AF at admission or during hospital stay, before or after stent implantation .

Eligibility criteria: Inclusion Criteria:

* All consecutive ACS patients treated with PCI with stent implantation who present AF at admission or during hospital stay, before or after stent implantation.

Exclusion Criteria:

* Patients admitted with a diagnosis of ACS at the time of enrolment but not confirmed during hospitalization
* ACS treated medically or with PCI but without stent implantation
* Patients not giving informed consent

Primary outcomes:
measure: Clinical epidemiology
timeFrame: Enrollement
measure: Management
timeFrame: 6 months
measure: Antithrombotic strategy
timeFrame: 6 months
measure: Clinical epidemiology
timeFrame: Enrollement
measure: Clinical epidemiology
timeFrame: Enrollement
measure: Clinical epidemiology
timeFrame: Enrollement
measure: Management
timeFrame: 6 months
measure: Number of procedure performed on enrolled patients
timeFrame: 6 months
Secondary outcomes:
measure: Pharmacological therapies
timeFrame: 6 months
measure: Clinical outcomes
timeFrame: 6 months
Other outcomes:
Locations:
city: Avezzano
country: Italy
facility: Ospedale Civile Ss. Filippo E Nicola - U.O. Cardiologia E Utic
state: AQ
city: Avellino
country: Italy
facility: Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti'
state: AV
city: Bari
country: Italy
facility: Ospedale Di Venere - U.O.C. Di Cardiologia
state: BA
city: Bari
country: Italy
facility: Ospedale San Paolo - Cardiologia-Utic
state: BA
city: Bari
country: Italy
facility: Ospedale Policlinico - U.O. Cardiologia Universitaria
state: BA
city: Benevento
country: Italy
facility: Azienda Ospedaliera G. Rummo - Cardiologia Interventistica E Utic
state: BD
city: Treviglio
country: Italy
facility: Ospedali Treviglio-Caravaggio - Cardiologia
state: BG
city: Belluno
country: Italy
facility: Ospedale Civile - Sc Cardiologia
state: BL
city: Bologna
country: Italy
facility: Ospedale Maggiore - U.O. Di Cardiologia
state: BO
city: Imola
country: Italy
facility: Ospedale Nuovo S. Maria Della Scaletta - Uoc Cardiologia
state: BO
city: Brindisi
country: Italy
facility: Ospedale Perrino - U.O.C. Di Cardiologia
state: BR
city: Andria
country: Italy
facility: Osp. Andria Canosa - Po Andria - Cardiologia - Utic
state: BT
city: Cagliari
country: Italy
facility: Azienda Ospedaliera G. Brotzu - Struttura Complessa Di Cardiologia
state: CA
city: Aversa
country: Italy
facility: Presidio Ospedaliero Moscati - U.O.C. Cardiologia
state: CE
city: Caserta
country: Italy
facility: Az. Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia-Utic
state: CE
city: Castel Volturno
country: Italy
facility: Pineta Grande Hospital - Unita Terapia Intensiva Coronarica
state: CE
city: Santa Maria Capua Vetere
country: Italy
facility: Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic
state: CE
city: Gravedona
country: Italy
facility: Ospedale Moriggia Pelascini - Unita' Operativa Di Cardiologia
state: CO
city: Catania
country: Italy
facility: Azienda Ospedaliera Cannizzaro - Uoc Cardiologia Con Utic Ed Emodinamica
state: CT
city: Forlì
country: Italy
facility: Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia
state: FC
city: Foggia
country: Italy
facility: Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic
state: FG
city: San Severo
country: Italy
facility: Presidio Ospedaliero T. Masselli Mascia - S.C. Cardiologia - Utic - Riabil. Card.
state: FG
city: Firenze
country: Italy
facility: Ospedale San Giovanni Di Dio - Cardiologia
state: FI
city: Genova
country: Italy
facility: E.O. Ospedali Galliera - S. C. Cardiologia
state: GE
city: Merate
country: Italy
facility: Ospedale San Leopoldo Mandic - Cardiologia - Ucc
state: LC
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi - U.O. Di Cardiologia
state: LE
city: Tricase
country: Italy
facility: Azienda Osp. Cardinale G. Panico - U.O. Cardiologia - Utic
state: LE
city: Lido Di Camaiore
country: Italy
facility: Nuovo Ospedale Versilia - Sc Cardiologia
state: LU
city: Desio
country: Italy
facility: Ospedale Di Circolo Di Desio - U.O.C. Di Cardiologia-Utic
state: MB
city: Legnano
country: Italy
facility: Ospedale Civile - Uo Cardiologia
state: MI
city: Magenta
country: Italy
facility: Ospedale Civile Fornaroli - U.O. Cardiologia
state: MI
city: Milano
country: Italy
facility: Centro Cardiologico Monzino - Terapia Intensiva Cardiologica (Utic)
state: MI
city: Milano
country: Italy
facility: Ospedale San Paolo - Uo Cardiologia E Utic
state: MI
city: Milano
country: Italy
facility: Ospedale San Luca - Istituto Auxologico - U.O. Cardiologia
state: MI
city: Milano
country: Italy
facility: Ospedale San Carlo Borromeo - Cardiologia-Ucc
state: MI
city: Milano
country: Italy
facility: Asst Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica
state: MI
city: Rho
country: Italy
facility: Ospedale Civile - Unita' Operativa Di Cardiologia
state: MI
city: Sassuolo
country: Italy
facility: Ospedale Di Sassuolo - Cardiologia
state: MO
city: Nuoro
country: Italy
facility: Ospedale San Francesco - Cardiologia - Utic
state: NU
city: Cefalù
country: Italy
facility: Fondazione G. Giglio - U.O. Cardiologia E Utic
state: PA
city: Palermo
country: Italy
facility: Aor Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello
state: PA
city: Foligno
country: Italy
facility: Nuovo Ospedale San Giovanni Battista - S.C. Cardiologia
state: PG
city: Pordenone
country: Italy
facility: Ospedale Di Pordenone - S.O.C. Cardiologia
state: PN
city: Pescia
country: Italy
facility: Ospedale Della Val Di Nievole - U. O. Cardiologia - Utic
state: Point
city: Pistoia
country: Italy
facility: Ospedale San Jacopo - U.O. Cardiologia
state: Point
city: Pesaro
country: Italy
facility: Presidio Ospedaliero San Salvatore - Cardiologia E Utic
state: PU
city: Pavia
country: Italy
facility: Fondazione Irccs Policlinico San Matteo - Card. Con Ucc-Lab. Ricerca Sperim. Card.
state: PV
city: Potenza
country: Italy
facility: Azienda Ospedaliera San Carlo - Ssd Utic
state: PZ
city: Reggio Calabria
country: Italy
facility: Ao Bianchi Melacrino Morelli- Po Riuniti - Divisione Di Cardiologia
state: RC
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova - S.C. Cardiologia
state: RE
city: Ragusa
country: Italy
facility: Ospedale M.P. Arezzo - U.O.C. Cardiologia-Utic
state: RG
city: Roma
country: Italy
facility: P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic
state: RM
city: Roma
country: Italy
facility: Ospedale San Camillo - Uoc Cardiologia 1
state: RM
city: Roma
country: Italy
facility: Policlinico Umberto Primo - Cardiologia B - Cardiologia E Angiologia
state: RM
city: Roma
country: Italy
facility: Ospedale Sant'Andrea Di Roma - U.O.C. Cardiologia
state: RM
city: Roma
country: Italy
facility: Ospedale Santo Spirito - U.O.C. Di Cardiologia
state: RM
city: Tivoli
country: Italy
facility: Ospedale San Giovanni Evangelista - U.O.C. Di Cardiologia - Utic
state: RM
city: Eboli
country: Italy
facility: Ospedale Maria Ss. Addolorata - U.O. Di Cardiologia Utic
state: SA
city: Savona
country: Italy
facility: Ospedale San Paolo - U.O. Di Cardiologia
state: SV
city: Rovereto
country: Italy
facility: Ospedale Santa Maria Del Carmine - Cardiologia
state: TN
city: Trento
country: Italy
facility: Ospedale Santa Chiara - Ospedale Santa Chiara
state: TN
city: Orbassano
country: Italy
facility: Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia
state: TO
city: Rivoli
country: Italy
facility: Ospedale Degli Infermi - Sc Cardiologia
state: TO
city: Torino
country: Italy
facility: Ospedale Maria Vittoria - U.O. Cardiologia
state: TO
city: Torino
country: Italy
facility: Ospedale Giovanni Bosco - Sc Cardiologia
state: TO
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria - S.C. Di Cardiologia
state: TR
city: Conegliano
country: Italy
facility: Ospedale Santa Maria Dei Battuti - U.O. Di Cardiologia
state: TV
city: Udine
country: Italy
facility: Pou Santa Maria Della Misericordia - S.O.C. Cardiologia
state: UD
city: Varese
country: Italy
facility: Ospedale Di Circolo E Fondazione Macchi - Ssd Unita' Di Cure Intensive Coronariche
state: VA
city: Mirano
country: Italy
facility: Ospedale Civile - U.O. Cardiologia
state: VE
city: San Donà Di Piave
country: Italy
facility: Ospedale Civile - U.O. Cardiologia
state: VE
city: Peschiera Del Garda
country: Italy
facility: Casa Di Cura Dr. Pederzoli - Servizio Di Cardiologia
state: VR
city: Viterbo
country: Italy
facility: Ospedale Belcolle - U.O.C. Cardiologia Utic Emodinamica
state: VT
city: Napoli
country: Italy
facility: Aorn Cardarelli - U.O. Cardiologia Con Utic
city: Napoli
country: Italy
facility: Ospedale Del Mare - U.O. Cardiologia Con Utic
city: Nola
country: Italy
facility: Pres. Ospedaliero S. Maria Della Pieta' - U.O. Cardiologia E Utic
Study officials:
References:
citation: De Luca L, Bolognese L, Rubboli A, Vetrano A, Callerame M, Rivetti L, Gonzini L, Gabrielli D, Di Lenarda A, Gulizia MM; MATADOR-PCI Investigators. Combinations of antithrombotic therapies prescribed after percutaneous coronary intervention in patients with acute coronary syndromes and atrial fibrillation: data from the nationwide MATADOR-PCI registry. Eur Heart J Cardiovasc Pharmacother. 2021 May 23;7(3):e45-e47. doi: 10.1093/ehjcvp/pvaa088. No abstract available.
citation: De Luca L, Rubboli A, Bolognese L, Gonzini L, Urbinati S, Murrone A, Scotto di Uccio F, Ferrari F, Luca F, Caldarola P, Lucci D, Gabrielli D, Di Lenarda A, Gulizia MM; MATADOR-PCI Investigators. Antithrombotic management of patients with acute coronary syndrome and atrial fibrillation undergoing coronary stenting: a prospective, observational, nationwide study. BMJ Open. 2020 Dec 22;10(12):e041044. doi: 10.1136/bmjopen-2020-041044.