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

Completed

• Conditions: Acute Coronary Syndrome; Atrial Fibrillation

• 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

Primary Outcome Measures

Name	Time	Method
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
Clinical epidemiology	Enrollement	Type of ACS

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

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

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

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

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

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

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

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

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