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

• Sponsor: Heart Care Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT03656523
• Collaborator: (none)
• Enrollment: 598
• Locations: 76
• Actual Duration (Months): 24.8
• Patients Per Site: 7.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome; Atrial Fibrillation	Other: Acute coronary syndrome and PCI and AF

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 598 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Management of Antithrombotic TherApy in Patients With Atrial Fibrillation or DevelOping AtRial Fibrillation During Hospitalization for PCI
• Actual Study Start Date: Jul 25, 2018
• Actual Primary Completion Date: Aug 17, 2020
• Actual Study Completion Date: Aug 17, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Clinical epidemiology [Enrollement]

   Demographics

2. Management [6 months]

   Pharmacological treatment

3. Antithrombotic strategy [6 months]

   Intravenous or oral antiplatelet and anticoagulation therapies and their combination

4. Clinical epidemiology [Enrollement]

   Clinical history

5. Clinical epidemiology [Enrollement]

   Type of AF

6. Clinical epidemiology [Enrollement]

   Type of ACS

7. Management [6 months]

   Time of PCI

8. Number of procedure performed on enrolled patients [6 months]

   In-hospital management

Secondary Outcome Measures

1. Pharmacological therapies [6 months]

   Use and persistence of therapies prescribed at discharge

2. Clinical outcomes [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Heart Care Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Heart Care Foundation
• ClinicalTrials.gov Identifier: NCT03656523
• Other Study ID Numbers: K20
• First Posted: Sep 4, 2018
• Last Update Posted: Feb 3, 2021
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Heart Care Foundation: Acute Coronary Syndrome; Atrial Fibrillation; Percutaneous Coronary Intervention
• Additional relevant MeSH terms: Atrial Fibrillation; Acute Coronary Syndrome

Study Results

No Results Posted as of Feb 3, 2021