AzTrials
AzTrials

Acute Coronary SyndromeMatador-PCINCT03656523

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

An observational study of Acute Coronary Syndrome and Atrial Fibrillation, run by Heart Care Foundation at 76 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome, Atrial Fibrillation
What is being tested?
Acute coronary syndrome and PCI and AF
How many people
598 participants
Where
76 sitesItaly
Study dates
25 Jul 2018to 17 Aug 2020
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

76 sites in 1 country.

76 sites in 1 country

Italy76 sites

  • Osp. Andria Canosa - Po Andria - Cardiologia - Utic

    Andria, BT, 76123

  • Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti'

    Avellino, AV, 83100

  • Presidio Ospedaliero Moscati - U.O.C. Cardiologia

    Aversa, CE, 81031

  • Ospedale Civile Ss. Filippo E Nicola - U.O. Cardiologia E Utic

    Avezzano, AQ, 67051

  • Ospedale Di Venere - U.O.C. Di Cardiologia

    Bari, BA, 70012

  • Ospedale San Paolo - Cardiologia-Utic

    Bari, BA, 70123

  • Ospedale Policlinico - U.O. Cardiologia Universitaria

    Bari, BA, 70124

  • Ospedale Civile - Sc Cardiologia

    Belluno, BL, 32100

  • Azienda Ospedaliera G. Rummo - Cardiologia Interventistica E Utic

    Benevento, BD, 82100

  • Ospedale Maggiore - U.O. Di Cardiologia

    Bologna, BO, 40133

  • Ospedale Perrino - U.O.C. Di Cardiologia

    Brindisi, BR, 72100

  • Azienda Ospedaliera G. Brotzu - Struttura Complessa Di Cardiologia

    Cagliari, CA, 09134

  • Az. Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia-Utic

    Caserta, CE, 81100

  • Pineta Grande Hospital - Unita Terapia Intensiva Coronarica

    Castel Volturno, CE, 81030

  • Azienda Ospedaliera Cannizzaro - Uoc Cardiologia Con Utic Ed Emodinamica

    Catania, CT, 95126

  • Fondazione G. Giglio - U.O. Cardiologia E Utic

    Cefalù, PA, 90015

  • Ospedale Santa Maria Dei Battuti - U.O. Di Cardiologia

    Conegliano, TV, 31015

  • Ospedale Di Circolo Di Desio - U.O.C. Di Cardiologia-Utic

    Desio, MB, 20832

  • Ospedale Maria Ss. Addolorata - U.O. Di Cardiologia Utic

    Eboli, SA, 84025

  • Ospedale San Giovanni Di Dio - Cardiologia

    Florence, FI, 50124

  • Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic

    Foggia, FG, 71100

  • Nuovo Ospedale San Giovanni Battista - S.C. Cardiologia

    Foligno, PG, 06034

  • Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia

    Forlì, FC, 47100

  • E.O. Ospedali Galliera - S. C. Cardiologia

    Genova, GE, 16128

  • Ospedale Moriggia Pelascini - Unita' Operativa Di Cardiologia

    Gravedona, CO, 22015

  • Ospedale Nuovo S. Maria Della Scaletta - Uoc Cardiologia

    Imola, BO, 40026

  • Ospedale Vito Fazzi - U.O. Di Cardiologia

    Lecce, LE, 73100

  • Ospedale Civile - Uo Cardiologia

    Legnano, MI, 20025

  • Nuovo Ospedale Versilia - Sc Cardiologia

    Lido di Camaiore, LU, 55043

  • Ospedale Civile Fornaroli - U.O. Cardiologia

    Magenta, MI, 20013

  • Ospedale San Leopoldo Mandic - Cardiologia - Ucc

    Merate, LC, 23807

  • Centro Cardiologico Monzino - Terapia Intensiva Cardiologica (Utic)

    Milan, MI, 20138

  • Ospedale San Paolo - Uo Cardiologia E Utic

    Milan, MI, 20142

  • Ospedale San Luca - Istituto Auxologico - U.O. Cardiologia

    Milan, MI, 20149

  • Ospedale San Carlo Borromeo - Cardiologia-Ucc

    Milan, MI, 20153

  • Asst Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica

    Milan, MI, 20162

  • Ospedale Civile - U.O. Cardiologia

    Mirano, VE, 30035

  • Aorn Cardarelli - U.O. Cardiologia Con Utic

    Naples, 80131

  • Ospedale Del Mare - U.O. Cardiologia Con Utic

    Naples, 80142

  • Pres. Ospedaliero S. Maria Della Pieta' - U.O. Cardiologia E Utic

    Nola, 80035

  • Ospedale San Francesco - Cardiologia - Utic

    Nuoro, NU, 08100

  • Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia

    Orbassano, TO, 10043

  • Aor Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello

    Palermo, PA, 90146

  • Fondazione Irccs Policlinico San Matteo - Card. Con Ucc-Lab. Ricerca Sperim. Card.

    Pavia, PV, 27100

  • Presidio Ospedaliero San Salvatore - Cardiologia E Utic

    Pesaro, PU, 61121

  • Casa Di Cura Dr. Pederzoli - Servizio Di Cardiologia

    Peschiera del Garda, VR, 37019

  • Ospedale Della Val Di Nievole - U. O. Cardiologia - Utic

    Pescia, Point, 51017

  • Ospedale San Jacopo - U.O. Cardiologia

    Pistoia, Point, 51100

  • Ospedale Di Pordenone - S.O.C. Cardiologia

    Pordenone, PN, 33170

  • Azienda Ospedaliera San Carlo - Ssd Utic

    Potenza, PZ, 85100

  • Ospedale M.P. Arezzo - U.O.C. Cardiologia-Utic

    Ragusa, RG, 97100

  • Ao Bianchi Melacrino Morelli- Po Riuniti - Divisione Di Cardiologia

    Reggio Calabria, RC, 89124

  • Arcispedale Santa Maria Nuova - S.C. Cardiologia

    Reggio Emilia, RE, 42100

  • Ospedale Civile - Unita' Operativa Di Cardiologia

    Rho, MI, 20017

  • Ospedale Degli Infermi - Sc Cardiologia

    Rivoli, TO, 10098

  • P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic

    Roma, RM, 00135

  • Ospedale San Camillo - Uoc Cardiologia 1

    Roma, RM, 00152

  • Policlinico Umberto Primo - Cardiologia B - Cardiologia E Angiologia

    Roma, RM, 00161

  • Ospedale Sant'Andrea Di Roma - U.O.C. Cardiologia

    Roma, RM, 00189

  • Ospedale Santo Spirito - U.O.C. Di Cardiologia

    Roma, RM, 00193

  • Ospedale Santa Maria Del Carmine - Cardiologia

    Rovereto, TN, 38068

  • Ospedale Civile - U.O. Cardiologia

    San Donà di Piave, VE, 30027

  • Presidio Ospedaliero T. Masselli Mascia - S.C. Cardiologia - Utic - Riabil. Card.

    San Severo, FG, 71016

  • Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic

    Santa Maria Capua Vetere, CE, 81055

  • Ospedale Di Sassuolo - Cardiologia

    Sassuolo, MO, 41049

  • Ospedale San Paolo - U.O. Di Cardiologia

    Savona, SV, 17100

  • Azienda Ospedaliera Santa Maria - S.C. Di Cardiologia

    Terni, TR, 05100

  • Ospedale San Giovanni Evangelista - U.O.C. Di Cardiologia - Utic

    Tivoli, RM, 00019

  • Ospedale Maria Vittoria - U.O. Cardiologia

    Torino, TO, 10149

  • Ospedale Giovanni Bosco - Sc Cardiologia

    Torino, TO, 10155

  • Ospedale Santa Chiara - Ospedale Santa Chiara

    Trento, TN, 38122

  • Ospedali Treviglio-Caravaggio - Cardiologia

    Treviglio, BG, 24047

  • Azienda Osp. Cardinale G. Panico - U.O. Cardiologia - Utic

    Tricase, LE, 73039

  • Pou Santa Maria Della Misericordia - S.O.C. Cardiologia

    Udine, UD, 33100

  • Ospedale Di Circolo E Fondazione Macchi - Ssd Unita' Di Cure Intensive Coronariche

    Varese, VA, 21100

  • Ospedale Belcolle - U.O.C. Cardiologia Utic Emodinamica

    Viterbo, VT, 01100

Other trials in Italy

About this study

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

Read the 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 .

Being tested
Acute coronary syndrome and PCI and AF
Keywords
Acute Coronary Syndrome, Atrial Fibrillation, Percutaneous Coronary Intervention
Medical subject headings
Acute Coronary Syndrome, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acute coronary syndrome and PCI and AFOther

    Patient with ACS and ACS treated with PCI

Study groups in NCT03656523
Study groupRoleWhat they receive
Acute Coronary SyndromePatients with Aute coronary syndrome trated with Percutaneous Coronary Intervention plus Stent implantation and Atrial Fibrillation
Receives: Other: Acute coronary syndrome and PCI and AF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical epidemiology

    Demographics

    Measured: Enrollement

  2. Management

    Pharmacological treatment

    Measured: 6 months

  3. Antithrombotic strategy

    Intravenous or oral antiplatelet and anticoagulation therapies and their combination

    Measured: 6 months

  4. Clinical epidemiology

    Clinical history

    Measured: Enrollement

  5. Clinical epidemiology

    Type of AF

    Measured: Enrollement

  6. Clinical epidemiology

    Type of ACS

    Measured: Enrollement

  7. Management

    Time of PCI

    Measured: 6 months

  8. Number of procedure performed on enrolled patients

    In-hospital management

    Measured: 6 months

Secondary outcomes (2)

  1. Pharmacological therapies

    Use and persistence of therapies prescribed at discharge

    Measured: 6 months

  2. Clinical outcomes

    All cause deaths, major bleedings, non fatal stroke, systemic embolism, transiet ischemic attach, MI recurrence

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2018
  2. Study start25 Jul 2018
  3. Primary completion17 Aug 2020
  4. Study completion17 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
598 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03656523
Sponsor's protocol ID
K20
Acronym
Matador-PCI
Status last verified
Oct 2020
First submitted
9 Aug 2018
Last updated
3 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32651996

  • 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.

    PubMed 33371033

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome and Atrial Fibrillation, run by Heart Care Foundation at 76 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical epidemiology (time frame: Enrollement). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03656523, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in