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

Completed

• Conditions: Acute Coronary Syndrome; Atrial Fibrillation
• Interventions: Other: Acute coronary syndrome and PCI and AF

• Registration Number: NCT03656523
• Lead Sponsor: Heart Care Foundation

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 .

Study Timeline

• Study Start: 2018-07-25
• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-04
• Primary Completion: 2020-08-17
• Study Completion: 2020-08-17
• Status Verified: 2020-10
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 598

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute Coronary Syndrome	Acute coronary syndrome and PCI and AF	Patients with Aute coronary syndrome trated with Percutaneous Coronary Intervention plus Stent implantation and Atrial Fibrillation

Primary Outcome Measures

Name	Time	Method
Clinical epidemiology	Enrollement	Type of ACS
Management	6 months	Time of PCI
Number of procedure performed on enrolled patients	6 months	In-hospital management
Antithrombotic strategy	6 months	Intravenous or oral antiplatelet and anticoagulation therapies and their combination

Secondary Outcome Measures

Name	Time	Method
Clinical outcomes	6 months	All cause deaths, major bleedings, non fatal stroke, systemic embolism, transiet ischemic attach, MI recurrence
Pharmacological therapies	6 months	Use and persistence of therapies prescribed at discharge

Trial Locations

Locations (75)

Ospedale Civile Ss. Filippo E Nicola - U.O. Cardiologia E Utic; 🇮🇹 Avezzano, AQ, Italy

Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti'; 🇮🇹 Avellino, AV, Italy

Ospedale Di Venere - U.O.C. Di Cardiologia; 🇮🇹 Bari, BA, Italy

Osp. Andria Canosa - Po Andria - Cardiologia - Utic; 🇮🇹 Andria, BT, Italy

Pineta Grande Hospital - Unita Terapia Intensiva Coronarica; 🇮🇹 Castel Volturno, CE, Italy

Azienda Ospedaliera Cannizzaro - Uoc Cardiologia Con Utic Ed Emodinamica; 🇮🇹 Catania, CT, Italy

Ospedale Policlinico - U.O. Cardiologia Universitaria; 🇮🇹 Bari, BA, Italy

Azienda Ospedaliera G. Brotzu - Struttura Complessa Di Cardiologia; 🇮🇹 Cagliari, CA, Italy

Presidio Ospedaliero Moscati - U.O.C. Cardiologia; 🇮🇹 Aversa, CE, Italy

Azienda Osp. Cardinale G. Panico - U.O. Cardiologia - Utic; 🇮🇹 Tricase, LE, Italy

Ospedale San Luca - Istituto Auxologico - U.O. Cardiologia; 🇮🇹 Milano, MI, Italy

Ospedale Sant'Andrea Di Roma - U.O.C. Cardiologia; 🇮🇹 Roma, RM, Italy

Ospedale San Paolo - Cardiologia-Utic; 🇮🇹 Bari, BA, Italy

Ospedale Maggiore - U.O. Di Cardiologia; 🇮🇹 Bologna, BO, Italy

Ospedale Perrino - U.O.C. Di Cardiologia; 🇮🇹 Brindisi, BR, Italy

Az. Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia-Utic; 🇮🇹 Caserta, CE, Italy

Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia; 🇮🇹 Forlì, FC, Italy

Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic; 🇮🇹 Foggia, FG, Italy

Presidio Ospedaliero T. Masselli Mascia - S.C. Cardiologia - Utic - Riabil. Card.; 🇮🇹 San Severo, FG, Italy

Ospedale San Giovanni Di Dio - Cardiologia; 🇮🇹 Firenze, FI, Italy

Ospedale Vito Fazzi - U.O. Di Cardiologia; 🇮🇹 Lecce, LE, Italy

Nuovo Ospedale Versilia - Sc Cardiologia; 🇮🇹 Lido Di Camaiore, LU, Italy

Ospedale Civile - Uo Cardiologia; 🇮🇹 Legnano, MI, Italy

Azienda Ospedaliera G. Rummo - Cardiologia Interventistica E Utic; 🇮🇹 Benevento, BD, Italy

Ospedali Treviglio-Caravaggio - Cardiologia; 🇮🇹 Treviglio, BG, Italy

Ospedale Nuovo S. Maria Della Scaletta - Uoc Cardiologia; 🇮🇹 Imola, BO, Italy

Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic; 🇮🇹 Santa Maria Capua Vetere, CE, Italy

Ospedale San Leopoldo Mandic - Cardiologia - Ucc; 🇮🇹 Merate, LC, Italy

Ospedale Civile - Sc Cardiologia; 🇮🇹 Belluno, BL, Italy

Ospedale Di Sassuolo - Cardiologia; 🇮🇹 Sassuolo, MO, Italy

Ospedale San Jacopo - U.O. Cardiologia; 🇮🇹 Pistoia, Point, Italy

Fondazione Irccs Policlinico San Matteo - Card. Con Ucc-Lab. Ricerca Sperim. Card.; 🇮🇹 Pavia, PV, Italy

Azienda Ospedaliera San Carlo - Ssd Utic; 🇮🇹 Potenza, PZ, Italy

Ospedale M.P. Arezzo - U.O.C. Cardiologia-Utic; 🇮🇹 Ragusa, RG, Italy

Ospedale Maria Ss. Addolorata - U.O. Di Cardiologia Utic; 🇮🇹 Eboli, SA, Italy

Ospedale Santa Chiara - Ospedale Santa Chiara; 🇮🇹 Trento, TN, Italy

Ospedale Maria Vittoria - U.O. Cardiologia; 🇮🇹 Torino, TO, Italy

Azienda Ospedaliera Santa Maria - S.C. Di Cardiologia; 🇮🇹 Terni, TR, Italy

Ospedale Civile - U.O. Cardiologia; 🇮🇹 San Donà Di Piave, VE, 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 Del Mare - U.O. Cardiologia Con Utic; 🇮🇹 Napoli, Italy

E.O. Ospedali Galliera - S. C. Cardiologia; 🇮🇹 Genova, GE, Italy

Ospedale Di Circolo Di Desio - U.O.C. Di Cardiologia-Utic; 🇮🇹 Desio, MB, Italy

Centro Cardiologico Monzino - Terapia Intensiva Cardiologica (Utic); 🇮🇹 Milano, MI, Italy

Ospedale San Paolo - Uo Cardiologia E Utic; 🇮🇹 Milano, MI, Italy

Ospedale San Carlo Borromeo - Cardiologia-Ucc; 🇮🇹 Milano, MI, Italy

Asst Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica; 🇮🇹 Milano, MI, Italy

Ospedale Civile - Unita' Operativa Di Cardiologia; 🇮🇹 Rho, MI, Italy

Ospedale San Francesco - Cardiologia - Utic; 🇮🇹 Nuoro, NU, Italy

Fondazione G. Giglio - U.O. Cardiologia E Utic; 🇮🇹 Cefalù, PA, Italy

Aor Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello; 🇮🇹 Palermo, PA, Italy

Ospedale Della Val Di Nievole - U. O. Cardiologia - Utic; 🇮🇹 Pescia, Point, 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

P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic; 🇮🇹 Roma, RM, Italy

Ospedale San Camillo - Uoc Cardiologia 1; 🇮🇹 Roma, RM, Italy

Policlinico Umberto Primo - Cardiologia B - Cardiologia E Angiologia; 🇮🇹 Roma, RM, Italy

Ospedale Santo Spirito - U.O.C. Di Cardiologia; 🇮🇹 Roma, RM, Italy

Ospedale San Giovanni Evangelista - U.O.C. Di Cardiologia - Utic; 🇮🇹 Tivoli, RM, Italy

Ospedale San Paolo - U.O. Di Cardiologia; 🇮🇹 Savona, SV, Italy

Ospedale Santa Maria Del Carmine - Cardiologia; 🇮🇹 Rovereto, TN, Italy

Ospedale Degli Infermi - Sc Cardiologia; 🇮🇹 Rivoli, TO, Italy

Ospedale Giovanni Bosco - Sc Cardiologia; 🇮🇹 Torino, TO, Italy

Ospedale Santa Maria Dei Battuti - U.O. Di Cardiologia; 🇮🇹 Conegliano, TV, Italy

Ospedale Belcolle - U.O.C. Cardiologia Utic Emodinamica; 🇮🇹 Viterbo, VT, Italy

Aorn Cardarelli - U.O. Cardiologia Con Utic; 🇮🇹 Napoli, Italy

Pres. Ospedaliero S. Maria Della Pieta' - U.O. Cardiologia E Utic; 🇮🇹 Nola, Italy

Ospedale Moriggia Pelascini - Unita' Operativa Di Cardiologia; 🇮🇹 Gravedona, CO, Italy

Ospedale Civile Fornaroli - U.O. Cardiologia; 🇮🇹 Magenta, MI, Italy

Nuovo Ospedale San Giovanni Battista - S.C. Cardiologia; 🇮🇹 Foligno, PG, Italy

Ospedale Di Pordenone - S.O.C. Cardiologia; 🇮🇹 Pordenone, PN, Italy

Presidio Ospedaliero San Salvatore - Cardiologia E Utic; 🇮🇹 Pesaro, PU, Italy

Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia; 🇮🇹 Orbassano, TO, Italy

Casa Di Cura Dr. Pederzoli - Servizio Di Cardiologia; 🇮🇹 Peschiera Del Garda, VR, Italy