Management of Antithrombotic TherApy in Patients With Atrial Fibrillation or DevelOping AtRial Fibrillation During Hospitalization for PCI

Atrial Fibrillation Clinical Trial

— Matador-PCI  

Official title:

Management of Antithrombotic TherApy in Patients With Atrial Fibrillation or DevelOping AtRial Fibrillation During Hospitalization for PCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656523
• Other study ID #: K20
• Status: Completed
• Start date: July 25, 2018
• Est. completion date: August 17, 2020

Study information

• Verified date: October 2020
• Source: Heart Care Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. completion date: August 17, 2020
• Est. primary completion date: August 17, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Atrial Fibrillation

Intervention

Other:
• Acute coronary syndrome and PCI and AF
Patient with ACS and ACS treated with PCI

Locations

Country	Name	City	State
Italy	Osp. Andria Canosa - Po Andria - Cardiologia - Utic	Andria	BT
Italy	Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti'	Avellino	AV
Italy	Presidio Ospedaliero Moscati - U.O.C. Cardiologia	Aversa	CE
Italy	Ospedale Civile Ss. Filippo E Nicola - U.O. Cardiologia E Utic	Avezzano	AQ
Italy	Ospedale Di Venere - U.O.C. Di Cardiologia	Bari	BA
Italy	Ospedale Policlinico - U.O. Cardiologia Universitaria	Bari	BA
Italy	Ospedale San Paolo - Cardiologia-Utic	Bari	BA
Italy	Ospedale Civile - Sc Cardiologia	Belluno	BL
Italy	Azienda Ospedaliera G. Rummo - Cardiologia Interventistica E Utic	Benevento	BD
Italy	Ospedale Maggiore - U.O. Di Cardiologia	Bologna	BO
Italy	Ospedale Perrino - U.O.C. Di Cardiologia	Brindisi	BR
Italy	Azienda Ospedaliera G. Brotzu - Struttura Complessa Di Cardiologia	Cagliari	CA
Italy	Az. Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia-Utic	Caserta	CE
Italy	Pineta Grande Hospital - Unita Terapia Intensiva Coronarica	Castel Volturno	CE
Italy	Azienda Ospedaliera Cannizzaro - Uoc Cardiologia Con Utic Ed Emodinamica	Catania	CT
Italy	Fondazione G. Giglio - U.O. Cardiologia E Utic	Cefalù	PA
Italy	Ospedale Santa Maria Dei Battuti - U.O. Di Cardiologia	Conegliano	TV
Italy	Ospedale Di Circolo Di Desio - U.O.C. Di Cardiologia-Utic	Desio	MB
Italy	Ospedale Maria Ss. Addolorata - U.O. Di Cardiologia Utic	Eboli	SA
Italy	Ospedale San Giovanni Di Dio - Cardiologia	Firenze	FI
Italy	Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic	Foggia	FG
Italy	Nuovo Ospedale San Giovanni Battista - S.C. Cardiologia	Foligno	PG
Italy	Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia	Forlì	FC
Italy	E.O. Ospedali Galliera - S. C. Cardiologia	Genova	GE
Italy	Ospedale Moriggia Pelascini - Unita' Operativa Di Cardiologia	Gravedona	CO
Italy	Ospedale Nuovo S. Maria Della Scaletta - Uoc Cardiologia	Imola	BO
Italy	Ospedale Vito Fazzi - U.O. Di Cardiologia	Lecce	LE
Italy	Ospedale Civile - Uo Cardiologia	Legnano	MI
Italy	Nuovo Ospedale Versilia - Sc Cardiologia	Lido Di Camaiore	LU
Italy	Ospedale Civile Fornaroli - U.O. Cardiologia	Magenta	MI
Italy	Ospedale San Leopoldo Mandic - Cardiologia - Ucc	Merate	LC
Italy	Asst Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica	Milano	MI
Italy	Centro Cardiologico Monzino - Terapia Intensiva Cardiologica (Utic)	Milano	MI
Italy	Ospedale San Carlo Borromeo - Cardiologia-Ucc	Milano	MI
Italy	Ospedale San Luca - Istituto Auxologico - U.O. Cardiologia	Milano	MI
Italy	Ospedale San Paolo - Uo Cardiologia E Utic	Milano	MI
Italy	Ospedale Civile - U.O. Cardiologia	Mirano	VE
Italy	Aorn Cardarelli - U.O. Cardiologia Con Utic	Napoli
Italy	Ospedale Del Mare - U.O. Cardiologia Con Utic	Napoli
Italy	Pres. Ospedaliero S. Maria Della Pieta' - U.O. Cardiologia E Utic	Nola
Italy	Ospedale San Francesco - Cardiologia - Utic	Nuoro	NU
Italy	Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia	Orbassano	TO
Italy	Aor Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello	Palermo	PA
Italy	Fondazione Irccs Policlinico San Matteo - Card. Con Ucc-Lab. Ricerca Sperim. Card.	Pavia	PV
Italy	Presidio Ospedaliero San Salvatore - Cardiologia E Utic	Pesaro	PU
Italy	Casa Di Cura Dr. Pederzoli - Servizio Di Cardiologia	Peschiera Del Garda	VR
Italy	Ospedale Della Val Di Nievole - U. O. Cardiologia - Utic	Pescia	Point
Italy	Ospedale San Jacopo - U.O. Cardiologia	Pistoia	Point
Italy	Ospedale Di Pordenone - S.O.C. Cardiologia	Pordenone	PN
Italy	Azienda Ospedaliera San Carlo - Ssd Utic	Potenza	PZ
Italy	Ospedale M.P. Arezzo - U.O.C. Cardiologia-Utic	Ragusa	RG
Italy	Ao Bianchi Melacrino Morelli- Po Riuniti - Divisione Di Cardiologia	Reggio Calabria	RC
Italy	Arcispedale Santa Maria Nuova - S.C. Cardiologia	Reggio Emilia	RE
Italy	Ospedale Civile - Unita' Operativa Di Cardiologia	Rho	MI
Italy	Ospedale Degli Infermi - Sc Cardiologia	Rivoli	TO
Italy	Ospedale San Camillo - Uoc Cardiologia 1	Roma	RM
Italy	Ospedale Sant'Andrea Di Roma - U.O.C. Cardiologia	Roma	RM
Italy	Ospedale Santo Spirito - U.O.C. Di Cardiologia	Roma	RM
Italy	P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic	Roma	RM
Italy	Policlinico Umberto Primo - Cardiologia B - Cardiologia E Angiologia	Roma	RM
Italy	Ospedale Santa Maria Del Carmine - Cardiologia	Rovereto	TN
Italy	Ospedale Civile - U.O. Cardiologia	San Donà Di Piave	VE
Italy	Presidio Ospedaliero T. Masselli Mascia - S.C. Cardiologia - Utic - Riabil. Card.	San Severo	FG
Italy	Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic	Santa Maria Capua Vetere	CE
Italy	Ospedale Di Sassuolo - Cardiologia	Sassuolo	MO
Italy	Ospedale San Paolo - U.O. Di Cardiologia	Savona	SV
Italy	Azienda Ospedaliera Santa Maria - S.C. Di Cardiologia	Terni	TR
Italy	Ospedale San Giovanni Evangelista - U.O.C. Di Cardiologia - Utic	Tivoli	RM
Italy	Ospedale Giovanni Bosco - Sc Cardiologia	Torino	TO
Italy	Ospedale Maria Vittoria - U.O. Cardiologia	Torino	TO
Italy	Ospedale Santa Chiara - Ospedale Santa Chiara	Trento	TN
Italy	Ospedali Treviglio-Caravaggio - Cardiologia	Treviglio	BG
Italy	Azienda Osp. Cardinale G. Panico - U.O. Cardiologia - Utic	Tricase	LE
Italy	Pou Santa Maria Della Misericordia - S.O.C. Cardiologia	Udine	UD
Italy	Ospedale Di Circolo E Fondazione Macchi - Ssd Unita' Di Cure Intensive Coronariche	Varese	VA
Italy	Ospedale Belcolle - U.O.C. Cardiologia Utic Emodinamica	Viterbo	VT

Sponsors (1)

Lead Sponsor	Collaborator
Heart Care Foundation

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. 2020 Jul 11. pii: pvaa088. doi: 10.1093/ehjcvp/pvaa088. [Epub ahead of print] — View Citation

De Luca L, Rubboli A, Bolognese L, Gonzini L, Urbinati S, Murrone A, Scotto di Uccio F, Ferrari F, Lucà F, Caldarola P, Lucci D, Gabrielli D, Di Lenarda A, Gulizia MM; MATADOR-PCI Investigators. Antithrombotic management of patients with acute coronary sy — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical epidemiology	Demographics	Enrollement
Primary	Management	Pharmacological treatment	6 months
Primary	Antithrombotic strategy	Intravenous or oral antiplatelet and anticoagulation therapies and their combination	6 months
Primary	Clinical epidemiology	Clinical history	Enrollement
Primary	Clinical epidemiology	Type of AF	Enrollement
Primary	Clinical epidemiology	Type of ACS	Enrollement
Primary	Management	Time of PCI	6 months
Primary	Number of procedure performed on enrolled patients	In-hospital management	6 months
Secondary	Pharmacological therapies	Use and persistence of therapies prescribed at discharge	6 months
Secondary	Clinical outcomes	All cause deaths, major bleedings, non fatal stroke, systemic embolism, transiet ischemic attach, MI recurrence	6 months