Treatment with a single drug that prevents blood clot formation followed by an anticoagulant drug in patients with irregular heartbeat who have undergone coronary blood flow restoration surgery with a stent (MATRIX-2)

Start 16 Dec 2024 · Status Ongoing, recruiting · 8 EU/EEA countries · 92 sites · Protocol MATRIX-2

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruiting

Participants planned 3,050

Countries 8

Sites 92

AF patients who have undergone successful PCI

Key facts

Sponsor: Insel Gruppe AG
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trial duration: 16 Dec 2024 → ongoing
Decision date (initial): 2024-09-10
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No
Funding sources: SAHAJANAND MEDICAL TECHNOLOGIES IRELAND LIMITED · Insel Gruppe AG, University Hospital Bern, Department of Cardiology

External identifiers

EU CT number: 2023-509717-36-00
ClinicalTrials.gov: NCT05955365

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The objectives of this study are to assess the safety, in terms of major or clinically relevant non-major bleeding, and the efficacy in terms of major adverse cardiac and cerebral events of a P2Y12 inhibitor monotherapy regimen for 1 month followed by DOAC monotherapy long-term versus current standard of care consisting of triple antithrombotic therapy for up to one month (aspirin, P2Y12 inhibitor and DOAC) followed by dual antithrombotic therapy (P2Y12 inhibitor and DOAC) for 6 to 12 months and DOAC monotherapy thereafter, in AF patients undergoing PCI indicated for treatment with a DOAC after sirolimus-eluting Supraflex Cruz stent implantation and followed for a period of 15 months.

Conditions and MedDRA coding

AF patients who have undergone successful PCI

Version	Level	Code	Term	System organ class
20.0	PT	10003658	Atrial fibrillation	100000004849
20.0	PT	10003662	Atrial flutter	100000004849
20.0	PT	10051592	Acute coronary syndrome	100000004849
24.0	PT	10085242	Chronic coronary syndrome	100000004849

Study design 1 period

#	Title	Allocation	Blinding	Roles blinded	Arms
1	15 months experimental period Investigator-initiated, multi-center, randomized, open label, blinded-evaluation, international clinical trial	Randomised Controlled	None		Experimental: Antithrombotic monotherapy Control: Standard of care strategy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

Age ≥ 18 years
Atrial fibrillation or flutter with an indication for oral anticoagulation using direct-acting oral anticoagulants (DOACs) for ≥ 12 months
Successful percutaneous coronary intervention in at least 1 lesion within the previous 7 days with no remaining lesions intended for treatment
Free from major adverse events post qualifying PCI, including new onset chest pain suspected to be of ischemic origin, acute or subacute stent thrombosis, new-onset neurological signs or symptoms
Written informed consent

Exclusion criteria 15

Planned staged percutaneous intervention procedure
Cardioversion for treatment of atrial fibrillation within 1 month prior to inclusion or planned cardioversion
Atrial fibrillation ablation procedure within 2 month prior to inclusion or planed atrial fibrillation ablation procedure
Prior mechanical valvular prosthesis implantation
Deep vein thrombosis/pulmonary embolism, at least moderately severe mitral stenosis or other clinical conditions than atrial fibrillation requiring long-term oral anticoagulation
Stroke within 1 month prior to randomization
Hemodynamic instability (persistent systolic blood pressure below 90 mmHg, continuous infusions of catecholamines, clinical signs of hypoperfusion and/or use of percutaneous left ventricular assist devices)
Uncontrolled severe hypertension with a systolic blood pressure (BP) ≥ 180 mmHg and/or diastolic BP ≥ 120 mmHg
Severe renal impairment with estimated creatinine clearance (CrCL) < 15 mL/min or on dialysis
Moderate and severe hepatic imparment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy
Any hypersensitivity or contraindications for direct oral anticoagulant or dual antiplatelet therapy with aspirin and a P2Y12 inhibitor
Any of the following abnormal local laboratory results prior to randomization: platelet count < 50x10^9/L or hemoglobin <8 g/dL
Known pregnancy or breast-feeding patients
Life expectancy <1 year due to other severe non-cardiac disease
Planned surgery including coronary artery bypass grafting within the next 6 months

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

Major adverse cardiac or cerebral events (MACCE), defined as the composite of death from any cause, myocardial infarction, stroke, or non-CNS systemic embolism between randomization and up to 12 months
Major or clinically relevant non-major bleeding (MCB) defined according to the International Society of Thrombosis and Hemostasis (ISTH) criteria between randomization and up to 12 months

Secondary endpoints 18

The individual components of each primary endpoints
The composite of death from cardiovascular causes, myocardial infarction, or stroke
The composite of death from cardiovascular causes, myocardial infarction, stroke or non-CNS systemic embolism
Death from cardiovascular or non-cardiovascular causes
The composite of stroke and non-CNS systemic embolism
Any stroke (including ischemic, hemorragic, and unknown types)
Ischemic stroke
Hemorrhagic stroke
Transient ischemic attack
The composite of definite or probable stent thrombosis
Definite stent thrombosis
Hospitalization
The composite of death or hospitalization
Any target lesion revascularization
Any target vessel revascularization
Any revascularization
All bleeding events, also adjudicated according to BARC, TIMI or GUSTO scales
Transfusion rates both in patients with and/or without clinically detected overt bleeding

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 7

Apixaban

SUB25425 · Substance

Active substance: Apixaban
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 11 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dabigatran

SUB25417 · Substance

Active substance: Dabigatran
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 300 mg milligram(s)
Max total dose: 300 mg milligram(s)
Max treatment duration: 11 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ticagrelor

SUB30898 · Substance

Active substance: Ticagrelor
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 180 mg milligram(s)
Max total dose: 180 mg milligram(s)
Max treatment duration: 1 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Prasugrel

SUB30236 · Substance

Active substance: Prasugrel
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 1 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rivaroxaban

SUB29263 · Substance

Active substance: Rivaroxaban
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 20 mg milligram(s)
Max treatment duration: 11 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Clopidogrel

SUB13395MIG · Substance

Active substance: Clopidogrel
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 75 mg milligram(s)
Max total dose: 75 mg milligram(s)
Max treatment duration: 1 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Edoxaban

SUB32701 · Substance

Active substance: Edoxaban
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 60 mg milligram(s)
Max total dose: 60 mg milligram(s)
Max treatment duration: 11 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Comparator 8

Dabigatran

SUB25417 · Substance

Active substance: Dabigatran
Pharmaceutical form: CAPSULE
Route of administration: ORAL
Max daily dose: 300 mg milligram(s)
Max total dose: 300 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Edoxaban

SUB32701 · Substance

Active substance: Edoxaban
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 60 mg milligram(s)
Max total dose: 60 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Prasugrel

SUB30236 · Substance

Active substance: Prasugrel
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 6 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rivaroxaban

SUB29263 · Substance

Active substance: Rivaroxaban
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 20 mg milligram(s)
Max total dose: 20 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Clopidogrel

SUB13395MIG · Substance

Active substance: Clopidogrel
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 75 mg milligram(s)
Max total dose: 75 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Apixaban

SUB25425 · Substance

Active substance: Apixaban
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ticagrelor

SUB30898 · Substance

Active substance: Ticagrelor
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 180 mg milligram(s)
Max total dose: 180 mg milligram(s)
Max treatment duration: 6 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Acetylsalicylic Acid

SUB12730MIG · Substance

Active substance: Acetylsalicylic Acid
Pharmaceutical form: GASTRO-RESISTANT CAPSULE
Route of administration: ORAL
Max daily dose: 100 mg milligram(s)
Max total dose: 100 mg milligram(s)
Max treatment duration: 1 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Insel Gruppe AG

Sponsor organisation: Insel Gruppe AG
Address: Freiburgstrasse 18
City: Bern
Postcode: 3010
Country: Switzerland

Scientific contact point

Organisation: Insel Gruppe AG
Contact name: Stefano Musardo

Public contact point

Organisation: Insel Gruppe AG
Contact name: Phidealive srl

Locations

8 EU/EEA countries · 92 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ongoing, recruiting	140	3
Finland		0	1
France	Ongoing, recruiting	320	22
Germany	Ongoing, recruiting	400	10
Italy	Ongoing, recruiting	340	27
Netherlands	Ongoing, recruiting	150	4
Poland	Ended	120	6
Spain	Ongoing, recruiting	230	19
Rest of world United Kingdom, Brazil, Switzerland	—	1,350	—

Investigational sites

Belgium

3 sites · Ongoing, recruiting

Az St-Jan Brugge-Oostende A.V.

Cardiology, Ruddershove 10, 8000, Brugge

Jessa Ziekenhuis

Cardiology, Stadsomvaart 11, 3500, Hasselt

CHU de Charleroi Hopital Civil Marie Curie

Cardiology, Chaussée de Bruxelles 140, 6042, Charleroi

Finland

1 site ·

Centre Hospitalier de Pau

Cardiology, 4 Boulevard Hauterive, 64000, Pau

France

22 sites · Ongoing, recruiting

Centre Hospitalier Universitaire De Montpellier

Cardiology, 191 Avenue Du Doyen Gaston Giraud, 34090, Montpellier

CHU Gabriel-Montpied

Cardiologie et medicine vasculaire, 58 Rue Montalembert, 63000, Clermont Ferrand

Clinique Pasteur

Groupe CardioVasculaire Interventionnel, 45 Avenue De Lombez, Cs 27617, Toulouse Cedex 3

Centre Hospitalier De Perpignan

Cardiology, 20 Avenue Du Languedoc, Cs 49954, Perpignan Cedex

Polyclinique Les Fleurs

Interventional cardiology, 332 Avenue Frédéric Mistral, 83190, Ollioules

Clinique du Millenaire

Cardiology, 220 Boulevard Pénélope, 34000, Montpelier

Hôpital privé Confluent

Cardiology, 4 Rue Eric Tabarly, 44277, Nantes

Hopital Prive Saint Martin-Caen

Cardiology, 18 Rue Des Roquemonts, 14000, Caen

Clinique Du Pont De Chaume

Cardiology and Vascular Medicine, 330 Avenue Marcel Unal, 82000, Montauban

Besancon University Hospital Center

Cardiology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex

Centre Hospitalier Annecy Genevois

Interventional Cardiology, 1 Avenue de l'Hopital, 74370, Epagny-Metz-Tessy

Clinique Axium

Cardiology, 21 Avenue Alfred Capus, 13100, Aix en Provence

Centre Hospitalier Universitaire De Lille

Cardiology, Boulevard Du Professeur Jules Leclercq, 59000, Lille

Clinique Saint Hilaire

Cardiology, 2 Place Saint Hilaire, 76000, Rouen

Centre Hospitalier Universitaire de Nimes

Cardiology, Place du Pr. Robert Debré, 30029, Nimes

Clinique Rhône Durance

Cardiology, 1750 Chemin du Lavarin, 84000, Avignon

GCS Axium-Rambot

Interventional Cardiology, 21 avenue Alfred Capus, 3097, AIX EN PROVENCE

Hopitaux Universitaires Pitie Salpetriere

Cardiology, 47 To 83 Boulevard De L Hopital, 75013, Paris

Centre Hospitalier Regional De Marseille

Interventional cardiology and coronary artery disease, 264 Rue Saint Pierre, 13005, Marseille

Centre Hospitalier Universitaire De Toulouse

Cardiology, 2 Rue Viguerie, 31300, Toulouse

Centre Hospitalier De Haguenau

Cardiology, 64 Avenue Du Professeur Rene Leriche, 67500, Haguenau

Institut Arnault Tzanck

Cardiology, Avenue Dr Maurice Donat, 231, Saint Laurent du var

Germany

10 sites · Ongoing, recruiting

LMU Klinikum München

Cardiology, Marchioninistr. 15, 81377, Munchen

Klinikum Friedrichshafen GmbH

Cardiology, Roentgenstrasse 2, Fischbach, Friedrichshafen

Universitätsklinikum Köln

Cardiology, Kerpener Strasse 62, 50937, Köln

Klinikum Landshut

Cardiology, Achdorfer Weg 3, 84036, Landshut

Segeberger Kliniken

Cardiology, Am Kurpak 1, 23795, Bad Segeberg

Barmherzige Brueder Trier gGmbH

Interventionelle Kardiologie, Nordallee 1, Trier-Nord, Trier

Klinikum Fürth

Cardiology, Jakob-Henle-Street 1, 90766, Fuerth

Universitätsklinikum Frankfurt am Main

Cardiology, Theodor-Stern-Kai 7, 60590, Frankfurt

ASKLEPIOS KLINIK Bad Oldesloe

Internal Medicine & Cardiology, Schiitzenstra8e 55, 23843, Bad Oldesloe

Elisabeth-Krankenhaus Essen GmbH

Heart and Vascular Center,, Klara-Kopp-Weg 1, Huttrop, Essen

Italy

27 sites · Ongoing, recruiting

Azienda Ospedaliera Regionale San Carlo

Cardiology, Via Potito Petrone, 85100, Potenza

Ospedale Maggiore di Lodi

Cardiologia, Largo Donatori del Sangue 1, 26900, Lodi

IRCCS Ospedale Auxologico San Luca

Cardiologia Interventistica, Piazzale Brescia 20, 20149, Milano

Azienda Ospedaliero Universitaria Delle Marche

Interventional Cardiology Unit, Via Conca 71, 60126, Ancona

Clinica Mediterranea

Cardiologia, Via Orazio 2, 80122, Napoli

Ospèedale degli Infermi di Rivoli

Cardiologia, Via Rivalta 29, 10098, Rivoli

Ospedale Sandro Pertini

Cardiologia, Via dei Monti Tiburtini 385, 00157, Roma

Fondazione Poliambulanza

Cardiology, Via Leonida Bissolati 57, 25124, Brescia

Azienda Ospedaliera Universitaria di Ferrara

cardiologia, Via Aldo Moro 8, Cona, Ferrara

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Cardiologia Interventistica, Via Cristina Belgioioso 173, 20157, Milano

IRCCS Policlinico San Matteo

Cardiologia Interventistica, Viale Camillo Golgi 19, 27100, Pavia

Policlinico Casilino

Cardiologia, Via Casilina 1049, 00169, Roma

Azienda Ospedaliera San'Anna e San Sebastiano di Caserta

Cardiologia, Via F. Palasciano, 81100, Caserta

IRCCS Istituto Clinico Humanitas

Cardiologia, Via Alessandro Manzoni 56, 20089, Rozzano

A.O.U. Policlinico "G. Rodolicp-San Marco"

Cardiologia, Via Santa Sofia 78, 95123, Catania

Ospedale Santa Corona

Cardiologia, Via XXV Aprile 38, 17027, Pietra Ligure

Policlinico Umberto I

Cardiologia Interventistica, Viale del Policlinico 155, 00161, Roma

Azienda Ospedaliera Ospedali Riuniti Marche Nord

DEA, Piazzale Carlo Cinelli 4, 61121, Pesaro

Ospedale San Giovanni Bosco

Cardiologia, Piazza del Donatore di Sangue 3, 10154, Torino

Fondazione IRCCS San Gerardo Dei Tintori

S.C. Emodinamica, Via Giovanni Battista Pergolesi 33, 20900, Monza

Ospedale Cardinal Massaia

Cardiologia, Corso Dante Alighieri 202, 14100, Asti

Ospedale Infermi di Rimini

Cardiology, Ospedale Infermi Viale Settembrini 2, 47900, Rimini

Asieda Ospedaliero-Universitaria di Parma

Cardiologia, Viale Antonio Gramsci 14, 43126, Parma

A.O.U. Gaetano Martino

Cardiologia, Via Consolare Valeria, 98124, Messina

Azienda Ospedaliera Universitaria Integrata Verona

Cardiologia, Piazzale Aristide Stefani 1, 37126, Verona

A.O.U. Città della Salute e dalla Scienza di Torino

Cardiologia, Corso Bramante 88/90, 10126, Torino

ASST Nord Milano-Ospedale Bassini

Cardiologia, Via Massimo Gorki 50, 20092, Cinisello Balsamo

Netherlands

4 sites · Ongoing, recruiting

Universitair Medisch Centrum Groningen

Cardiology, Hanzeplein 1, 9713 GZ, Groningen

Catharina Ziekenhuis Eindhoven

Cardiology, Michelangelolaaan 2, 5623 EJ, Eindhoven

Jeroen Bosch Hospital

Cardiology, Henri Dunantstraat 1, 5223 GV, 's-Hertogenbosch

Medisch Centrum Leeuwarden B.V.

Cardiology, Henri Dunantweg 2, 8934 AD, Leeuwarden

Poland

6 sites · Ended

Szpital Kliniczny Uniwersytetu Medycznego

Cardiology, Dluga 1/2, 60-355, Poznań

Uniwersytecki Szpital Kliniczny W Opolu

Cardiology, Al. Wincentego Witosa 26, 45-401, Opole

Uniwersytecki Szpital Kliniczny W Poznaniu

Cardiology, Ul. Stanislawa Przybyszewskiego 49, 60-355, Poznan

Medical University of Gdańsk

Cardiology, Smoluchowskiego 17, 80-214, Gdansk

National Institute of Cardiology Warsaw

Cardiology, Alpejska 42, 04-628, Warsaw

Gornoslaskie Centrum Mwdyczne

Cardiology, Ziolowa 45/47, 40-635, Katawice

Spain

19 sites · Ongoing, recruiting

Hospital Universitario Marques De Valdecilla

Coronary Intervention, Avenida Valdecilla Sn, 39008, Santander

Hospital Clinic De Barcelona

Cardiology, Calle Villarroel 170, 08036, Barcelona

Hospital Universitario Juan Ramon Jimenez

Intervensional Cardiology, Ronda Exterior Norte S/n, 21005, Huelva

Hospital Universitario Regional De Malaga

Cardiology, Avenida De Carlos De Haya S/N, 29010, Malaga

El Hospital Universitario De Gran Canaria Dr. Negrin

Cardiology, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria

Hospital Clinico San Carlos

Interventional Cardiology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid

Hospital General Universitario Reina Sofia

Cardiology, Avenida Menendez Pidal S/n, 14004, Cordoba

Hospital Clinico Universitario De Valladolid

Interventional Cardiology, Avenida Ramon Y Cajal 3, 47003, Valladolid

Complexo Hospitalario Universitario De Santiago

Cardiology, Calle Choupana Da S/n, 15706, Santiago De Compostela

Hospital Universitario Miguel Servet

Cardiology, Paseo Isabel la Catolica 1-3, 50009, Zaragoza

Hospital Universitario Y Politecnico La Fe

Cardiology, Avenida De Fernando Abril Martorell 106, 46026, Valencia

Bellvitge University Hospital

Cardiology, Carrer de la Feixa Llarga, s/n, Barcelona

Hospital Universitario De Leon

Cardiology, Calle Altos De Nava S/n, 24071, Leon

Hospital Universitario La Paz

Cardiology, Paseo De La Castellana 261, 28046, Madrid

University Hospital Son Espases

Cardiology, Carretera Valldemossa 79, 07120, Palma

Hospital Universitario Clinico San Cecilio

Cardiology, Avenida de la Innovacion, Spain, Granada

Hospital Virgen del Rocio

Cardiology, Avenida Manuel Siurot S/n, 41013, Sevilla

Hospital Clinico Universitario De Valencia

Interventional Cardiology, Avenida Blasco Ibanez 17, 46010, Valencia

Hospital De La Santa Creu I Sant Pau

Interventional Cardiology Unit, Carrer De San Quinti 89, 08041, Barcelona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Recruitment start
Belgium	2025-02-27	2025-03-24
France	2024-12-18	2025-02-07
Germany	2025-01-30	2025-06-05
Italy	2024-12-16	2025-01-16
Netherlands	2025-09-04	2025-09-12
Spain	2025-04-03	2025-06-19

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 66 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	MATRIX-2 Protocol	1
Protocol (for publication)	MATRIX-2 Protocol_Track Change	1
Recruitment arrangements (for publication)	K1 Recruitment and Informed consent procedure	2.0
Recruitment arrangements (for publication)	K1 Recruitment and Informed consent procedure_TC	2.0
Recruitment arrangements (for publication)	Recruitment and Informed consent procedure	1.0
Recruitment arrangements (for publication)	Recruitment and Informed consent procedure	1.0
Recruitment arrangements (for publication)	Recruitment and Informed consent procedure	1.0
Recruitment arrangements (for publication)	Recruitment and Informed consent procedure	1
Subject information and informed consent form (for publication)	L1 SIS and ICF	2.0
Subject information and informed consent form (for publication)	L1 SIS and ICF_TC	2.0
Subject information and informed consent form (for publication)	MATRIX-2 _Informativa e consenso dati personali GDP_IT	1
Subject information and informed consent form (for publication)	MATRIX-2 - GP Letter DE	1.0
Subject information and informed consent form (for publication)	MATRIX-2 - GP Letter ES	1.0
Subject information and informed consent form (for publication)	MATRIX-2 - GP Letter FR	1
Subject information and informed consent form (for publication)	MATRIX-2 - GP Letter IT	1
Subject information and informed consent form (for publication)	MATRIX-2_ Apendice 1 proteccion de datos_ES	1.0
Subject information and informed consent form (for publication)	MATRIX-2_ICF_DE	1.1
Subject information and informed consent form (for publication)	MATRIX-2_ICF_DE_TC	1.1
Subject information and informed consent form (for publication)	MATRIX-2_ICF_ES	1.0
Subject information and informed consent form (for publication)	MATRIX-2_ICF_FR	1.1
Subject information and informed consent form (for publication)	MATRIX-2_ICF_FR_TC	1.1
Subject information and informed consent form (for publication)	MATRIX-2_ICF_IT	1
Subject information and informed consent form (for publication)	MATRIX-2_Patient Diary FR	3.1 France
Subject information and informed consent form (for publication)	MATRIX-2_Patient Diary_DE	3.0
Subject information and informed consent form (for publication)	MATRIX-2_Patient Diary_ES	3.0
Subject information and informed consent form (for publication)	MATRIX-2_Patient Diary_FRA_TC	3.1
Subject information and informed consent form (for publication)	MATRIX-2_Patient Diary_IT	1
Subject information and informed consent form (for publication)	MATRIX-2_Privacy Informative DE	1.0
Subject information and informed consent form (for publication)	MMAS-8-ES	1
Subject information and informed consent form (for publication)	MMAS-8-FR	1.1
Subject information and informed consent form (for publication)	MMAS-8-FR_TC	1.1
Subject information and informed consent form (for publication)	MMAS-8-IT	1
Subject information and informed consent form (for publication)	MMSA 8_DE	1
Subject information and informed consent form (for publication)	TSQM V II_DE	2
Subject information and informed consent form (for publication)	TSQM V II_ES	2
Subject information and informed consent form (for publication)	TSQM V II_FR	2
Subject information and informed consent form (for publication)	TSQM V II_IT	1
Summary of Product Characteristics (SmPC) (for publication)	Apixaban SMPC	1
Summary of Product Characteristics (SmPC) (for publication)	Apixaban SMPC	1
Summary of Product Characteristics (SmPC) (for publication)	Cardioaspirin_SMPC	1
Summary of Product Characteristics (SmPC) (for publication)	Clopidrogrel_SMPC	1
Summary of Product Characteristics (SmPC) (for publication)	Clopidrogrel_SMPC	1
Summary of Product Characteristics (SmPC) (for publication)	Dabigatran SMPC	1
Summary of Product Characteristics (SmPC) (for publication)	Dabigatran SMPC	1
Summary of Product Characteristics (SmPC) (for publication)	Edoxaban SMPC	1
Summary of Product Characteristics (SmPC) (for publication)	Edoxaban SMPC	1
Summary of Product Characteristics (SmPC) (for publication)	Prasugrel SMPC	1
Summary of Product Characteristics (SmPC) (for publication)	Prasugrel SMPC	1
Summary of Product Characteristics (SmPC) (for publication)	Rivaroxaban SMPC	1
Summary of Product Characteristics (SmPC) (for publication)	Rivaroxaban SMPCpdf	1
Summary of Product Characteristics (SmPC) (for publication)	Ticagrerol SMPC	1
Summary of Product Characteristics (SmPC) (for publication)	Ticagrerol SMPC	1
Synopsis of the protocol (for publication)	DE 276_ Synopsis GER_redacted	1
Synopsis of the protocol (for publication)	DE 276_Synopsis GER_TC	1
Synopsis of the protocol (for publication)	ES 724_Synopsis SPA_redacted	1
Synopsis of the protocol (for publication)	ES 724_Synopsis_SPA_TC	1
Synopsis of the protocol (for publication)	FR 250_Synopsis FRA_redacted	1
Synopsis of the protocol (for publication)	FR 250_Synopsis FRA_TC	1
Synopsis of the protocol (for publication)	GB 826_Synopsis ENG_redacted	1
Synopsis of the protocol (for publication)	GB 826_Synopsis ENG_TC	1
Synopsis of the protocol (for publication)	IT 380_Synopsis ITA_redacted	1
Synopsis of the protocol (for publication)	IT 380_Synopsis ITA_TC	1
Synopsis of the protocol (for publication)	NL 529_Synopsis NLD_redacted	1
Synopsis of the protocol (for publication)	NL 529_Synopsis NLD_TC	1
Synopsis of the protocol (for publication)	PL 616_Synopsis POL_redacted	1
Synopsis of the protocol (for publication)	PL 616_Synopsis POL_TC	1

Application history

12 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-02-14	Italy	Acceptable 2024-06-03	2024-08-13
2	SUBSEQUENT ADDITION OF MSC	APP-2	2024-11-13		Acceptable 2024-06-03	2025-01-27
3	SUBSTANTIAL MODIFICATION	SM-2	2024-11-15	Italy	Acceptable	2025-02-03
4	SUBSTANTIAL MODIFICATION	SM-3	2024-12-18		Acceptable	2025-02-14
5	SUBSTANTIAL MODIFICATION	SM-4	2024-12-19		Acceptable	2025-02-11
6	SUBSTANTIAL MODIFICATION	SM-5	2025-05-23		Acceptable	2025-08-06
7	SUBSTANTIAL MODIFICATION	SM-6	2025-07-24		Acceptable	2025-10-06
8	SUBSTANTIAL MODIFICATION	SM-8	2025-08-27	Italy	Acceptable	2025-11-17
9	NON SUBSTANTIAL MODIFICATION	NSM-1	2025-11-25	Italy	Acceptable	2025-11-25
10	SUBSTANTIAL MODIFICATION	SM-9	2026-01-08		Acceptable	2026-02-17
11	SUBSTANTIAL MODIFICATION	SM-10	2026-02-24		Acceptable	2026-06-01
12	SUBSTANTIAL MODIFICATION	SM-11	2026-03-05	Italy	Acceptable	2026-04-15