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

February 2, 2021 updated by: Heart Care Foundation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

598

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • Aorn Cardarelli - U.O. Cardiologia Con Utic
      • Napoli, Italy, 80142
        • Ospedale Del Mare - U.O. Cardiologia Con Utic
      • Nola, Italy, 80035
        • Pres. Ospedaliero S. Maria Della Pieta' - U.O. Cardiologia E Utic
    • AQ
      • Avezzano, AQ, Italy, 67051
        • Ospedale Civile Ss. Filippo E Nicola - U.O. Cardiologia E Utic
    • AV
      • Avellino, AV, Italy, 83100
        • Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti'
    • BA
      • Bari, BA, Italy, 70123
        • Ospedale San Paolo - Cardiologia-Utic
      • Bari, BA, Italy, 70012
        • Ospedale Di Venere - U.O.C. Di Cardiologia
      • Bari, BA, Italy, 70124
        • Ospedale Policlinico - U.O. Cardiologia Universitaria
    • BD
      • Benevento, BD, Italy, 82100
        • Azienda Ospedaliera G. Rummo - Cardiologia Interventistica E Utic
    • BG
      • Treviglio, BG, Italy, 24047
        • Ospedali Treviglio-Caravaggio - Cardiologia
    • BL
      • Belluno, BL, Italy, 32100
        • Ospedale Civile - Sc Cardiologia
    • BO
      • Bologna, BO, Italy, 40133
        • Ospedale Maggiore - U.O. Di Cardiologia
      • Imola, BO, Italy, 40026
        • Ospedale Nuovo S. Maria Della Scaletta - Uoc Cardiologia
    • BR
      • Brindisi, BR, Italy, 72100
        • Ospedale Perrino - U.O.C. Di Cardiologia
    • BT
      • Andria, BT, Italy, 76123
        • Osp. Andria Canosa - Po Andria - Cardiologia - Utic
    • CA
      • Cagliari, CA, Italy, 09134
        • Azienda Ospedaliera G. Brotzu - Struttura Complessa Di Cardiologia
    • CE
      • Aversa, CE, Italy, 81031
        • Presidio Ospedaliero Moscati - U.O.C. Cardiologia
      • Caserta, CE, Italy, 81100
        • Az. Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia-Utic
      • Castel Volturno, CE, Italy, 81030
        • Pineta Grande Hospital - Unita Terapia Intensiva Coronarica
      • Santa Maria Capua Vetere, CE, Italy, 81055
        • Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic
    • CO
      • Gravedona, CO, Italy, 22015
        • Ospedale Moriggia Pelascini - Unita' Operativa Di Cardiologia
    • CT
      • Catania, CT, Italy, 95126
        • Azienda Ospedaliera Cannizzaro - Uoc Cardiologia Con Utic Ed Emodinamica
    • FC
      • Forlì, FC, Italy, 47100
        • Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia
    • FG
      • Foggia, FG, Italy, 71100
        • Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic
      • San Severo, FG, Italy, 71016
        • Presidio Ospedaliero T. Masselli Mascia - S.C. Cardiologia - Utic - Riabil. Card.
    • FI
      • Firenze, FI, Italy, 50124
        • Ospedale San Giovanni Di Dio - Cardiologia
    • GE
      • Genova, GE, Italy, 16128
        • E.O. Ospedali Galliera - S. C. Cardiologia
    • LC
      • Merate, LC, Italy, 23807
        • Ospedale San Leopoldo Mandic - Cardiologia - Ucc
    • LE
      • Lecce, LE, Italy, 73100
        • Ospedale Vito Fazzi - U.O. Di Cardiologia
      • Tricase, LE, Italy, 73039
        • Azienda Osp. Cardinale G. Panico - U.O. Cardiologia - Utic
    • LU
      • Lido Di Camaiore, LU, Italy, 55043
        • Nuovo Ospedale Versilia - Sc Cardiologia
    • MB
      • Desio, MB, Italy, 20832
        • Ospedale Di Circolo Di Desio - U.O.C. Di Cardiologia-Utic
    • MI
      • Legnano, MI, Italy, 20025
        • Ospedale Civile - Uo Cardiologia
      • Magenta, MI, Italy, 20013
        • Ospedale Civile Fornaroli - U.O. Cardiologia
      • Milano, MI, Italy, 20153
        • Ospedale San Carlo Borromeo - Cardiologia-Ucc
      • Milano, MI, Italy, 20162
        • Asst Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica
      • Milano, MI, Italy, 20138
        • Centro Cardiologico Monzino - Terapia Intensiva Cardiologica (Utic)
      • Milano, MI, Italy, 20149
        • Ospedale San Luca - Istituto Auxologico - U.O. Cardiologia
      • Milano, MI, Italy, 20142
        • Ospedale San Paolo - Uo Cardiologia E Utic
      • Rho, MI, Italy, 20017
        • Ospedale Civile - Unita' Operativa Di Cardiologia
    • MO
      • Sassuolo, MO, Italy, 41049
        • Ospedale Di Sassuolo - Cardiologia
    • NU
      • Nuoro, NU, Italy, 08100
        • Ospedale San Francesco - Cardiologia - Utic
    • PA
      • Cefalù, PA, Italy, 90015
        • Fondazione G. Giglio - U.O. Cardiologia E Utic
      • Palermo, PA, Italy, 90146
        • Aor Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello
    • PG
      • Foligno, PG, Italy, 06034
        • Nuovo Ospedale San Giovanni Battista - S.C. Cardiologia
    • PN
      • Pordenone, PN, Italy, 33170
        • Ospedale Di Pordenone - S.O.C. Cardiologia
    • PU
      • Pesaro, PU, Italy, 61121
        • Presidio Ospedaliero San Salvatore - Cardiologia E Utic
    • PV
      • Pavia, PV, Italy, 27100
        • Fondazione Irccs Policlinico San Matteo - Card. Con Ucc-Lab. Ricerca Sperim. Card.
    • PZ
      • Potenza, PZ, Italy, 85100
        • Azienda Ospedaliera San Carlo - Ssd Utic
    • Point
      • Pescia, Point, Italy, 51017
        • Ospedale Della Val Di Nievole - U. O. Cardiologia - Utic
      • Pistoia, Point, Italy, 51100
        • Ospedale San Jacopo - U.O. Cardiologia
    • RC
      • Reggio Calabria, RC, Italy, 89124
        • Ao Bianchi Melacrino Morelli- Po Riuniti - Divisione Di Cardiologia
    • RE
      • Reggio Emilia, RE, Italy, 42100
        • Arcispedale Santa Maria Nuova - S.C. Cardiologia
    • RG
      • Ragusa, RG, Italy, 97100
        • Ospedale M.P. Arezzo - U.O.C. Cardiologia-Utic
    • RM
      • Roma, RM, Italy, 00135
        • P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic
      • Roma, RM, Italy, 00152
        • Ospedale San Camillo - Uoc Cardiologia 1
      • Roma, RM, Italy, 00161
        • Policlinico Umberto Primo - Cardiologia B - Cardiologia E Angiologia
      • Roma, RM, Italy, 00189
        • Ospedale Sant'Andrea Di Roma - U.O.C. Cardiologia
      • Roma, RM, Italy, 00193
        • Ospedale Santo Spirito - U.O.C. Di Cardiologia
      • Tivoli, RM, Italy, 00019
        • Ospedale San Giovanni Evangelista - U.O.C. Di Cardiologia - Utic
    • SA
      • Eboli, SA, Italy, 84025
        • Ospedale Maria Ss. Addolorata - U.O. Di Cardiologia Utic
    • SV
      • Savona, SV, Italy, 17100
        • Ospedale San Paolo - U.O. Di Cardiologia
    • TN
      • Rovereto, TN, Italy, 38068
        • Ospedale Santa Maria Del Carmine - Cardiologia
      • Trento, TN, Italy, 38122
        • Ospedale Santa Chiara - Ospedale Santa Chiara
    • TO
      • Orbassano, TO, Italy, 10043
        • Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia
      • Rivoli, TO, Italy, 10098
        • Ospedale Degli Infermi - Sc Cardiologia
      • Torino, TO, Italy, 10155
        • Ospedale Giovanni Bosco - Sc Cardiologia
      • Torino, TO, Italy, 10149
        • Ospedale Maria Vittoria - U.O. Cardiologia
    • TR
      • Terni, TR, Italy, 05100
        • Azienda Ospedaliera Santa Maria - S.C. Di Cardiologia
    • TV
      • Conegliano, TV, Italy, 31015
        • Ospedale Santa Maria Dei Battuti - U.O. Di Cardiologia
    • UD
      • Udine, UD, Italy, 33100
        • Pou Santa Maria Della Misericordia - S.O.C. Cardiologia
    • VA
      • Varese, VA, Italy, 21100
        • Ospedale Di Circolo E Fondazione Macchi - Ssd Unita' Di Cure Intensive Coronariche
    • VE
      • Mirano, VE, Italy, 30035
        • Ospedale Civile - U.O. Cardiologia
      • San Donà Di Piave, VE, Italy, 30027
        • Ospedale Civile - U.O. Cardiologia
    • VR
      • Peschiera Del Garda, VR, Italy, 37019
        • Casa Di Cura Dr. Pederzoli - Servizio Di Cardiologia
    • VT
      • Viterbo, VT, Italy, 01100
        • Ospedale Belcolle - U.O.C. Cardiologia Utic Emodinamica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with ACS trated with PCI with stent implantation developing or having Atrial Fibrillation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute Coronary Syndrome
Patients with Aute coronary syndrome trated with Percutaneous Coronary Intervention plus Stent implantation and Atrial Fibrillation
Other: Acute coronary syndrome and PCI and AF
Patient with ACS and ACS treated with PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical epidemiology
Time Frame: Enrollement
Demographics
Enrollement
Management
Time Frame: 6 months
Pharmacological treatment
6 months
Antithrombotic strategy
Time Frame: 6 months
Intravenous or oral antiplatelet and anticoagulation therapies and their combination
6 months
Clinical epidemiology
Time Frame: Enrollement
Clinical history
Enrollement
Clinical epidemiology
Time Frame: Enrollement
Type of AF
Enrollement
Clinical epidemiology
Time Frame: Enrollement
Type of ACS
Enrollement
Management
Time Frame: 6 months
Time of PCI
6 months
Number of procedure performed on enrolled patients
Time Frame: 6 months
In-hospital management
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Care Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2018

Primary Completion (Actual)

August 17, 2020

Study Completion (Actual)

August 17, 2020

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

August 31, 2018

First Posted (Actual)

September 4, 2018

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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