Clinical trial • Phase III • Cardiology

RIVAROXABAN for Atrial fibrillation | Percutaneous coronary intervention

Phase III trial of RIVAROXABAN for Atrial fibrillation | Percutaneous coronary intervention.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Atrial fibrillation | Percutaneous coronary intervention
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
14-02-2024
First CTIS Authorization Date
13-08-2024

Trial design

Randomised, open-label, control (standard of care): triple antithrombotic therapy (aspirin, a p2y12 inhibitor and a doac) for up to one month followed by dual antithrombotic therapy (p2y12 inhibitor and doac) for 6 to 12 months and then doac monotherapy thereafter. allowed antiplatelet and anticoagulant products listed in dossier include: rivaroxaban, apixaban, dabigatran, edoxaban (doacs); ticagrelor, prasugrel, clopidogrel (p2y12 inhibitors); acetylsalicylic acid (aspirin). specific per-drug doses are provided in product entries (e.g. clopidogrel max daily 75 mg; acetylsalicylic acid max daily 100 mg; ticagrelor max daily 180 mg; doac max daily amounts as per product entries) but no single fixed comparator dosing schedule is mandated in the public trial summary. Phase III trial across 89 sites in Belgium, Poland, Netherlands and others.

Randomised
Yes
Open Label
Yes
Comparator
Control (standard of care): triple antithrombotic therapy (aspirin, a P2Y12 inhibitor and a DOAC) for up to one month followed by dual antithrombotic therapy (P2Y12 inhibitor and DOAC) for 6 to 12 months and then DOAC monotherapy thereafter. Allowed antiplatelet and anticoagulant products listed in dossier include: Rivaroxaban, Apixaban, Dabigatran, Edoxaban (DOACs); Ticagrelor, Prasugrel, Clopidogrel (P2Y12 inhibitors); Acetylsalicylic acid (aspirin). Specific per-drug doses are provided in product entries (e.g. clopidogrel max daily 75 mg; acetylsalicylic acid max daily 100 mg; ticagrelor max daily 180 mg; DOAC max daily amounts as per product entries) but no single fixed comparator dosing schedule is mandated in the public trial summary.
Target Sample Size
1350
Trial Duration For Participant
450

Eligibility

Recruits 1350 Vulnerable populations not selected (isVulnerablePopulationSelected: false). Written informed consent is required from each participant (adults ≥18 years). Consent information and data-processing consent (GDPR / UE/2016/679) are provided to the patient by the Investigator; participant data will be anonymised for analysis and access limited to authorised personnel..

Pregnancy Exclusion
Known pregnancy or breast-feeding patients
Vulnerable Population
Vulnerable populations not selected (isVulnerablePopulationSelected: false). Written informed consent is required from each participant (adults ≥18 years). Consent information and data-processing consent (GDPR / UE/2016/679) are provided to the patient by the Investigator; participant data will be anonymised for analysis and access limited to authorised personnel.

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 years\n- Atrial fibrillation or flutter with an indication for oral anticoagulation using direct-acting oral anticoagulants (DOACs) for ≥ 12 months\n- Successful percutaneous coronary intervention in at least 1 lesion within the previous 7 days with no remaining lesions intended for treatment\n- 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\n- Written informed consent"}

Exclusion criteria

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

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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","definition_or_measurement_approach":"Defined as the composite of death from any cause, myocardial infarction, stroke, or non-CNS systemic embolism occurring between randomization and up to 12 months."}
  • {"endpoint_text":"- 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","definition_or_measurement_approach":"Bleeding events adjudicated according to ISTH criteria between randomization and up to 12 months."}

Secondary endpoints

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

Recruitment

Planned Sample Size
1350
Recruitment Window Months
41
Consent Approach
Written informed consent is required from each participant (adults ≥18 years). Participant information and consent documentation are provided by the Investigator. Consent includes agreement to processing of personal data in accordance with GDPR (UE/2016/679); informational/privacy documents are delivered to the patient and data will be anonymised for analysis. Country-specific ICFs are provided (examples in dossier: German, Spanish, French, Italian and English-language ICF and information documents available for participating Member States).

Geography

Total Number Of Sites
89
Total Number Of Participants
1700

Belgium

Earliest CTIS Part Ii Submission Date
23-08-2024
Latest Decision Or Authorization Date
10-09-2024
Processing Time Days
18
Number Of Sites
3
Number Of Participants
140

Sites

Site Name
Jessa Ziekenhuis
Department Name
Cardiology
Contact Person Name
Pascal Vranckx
Contact Person Email
pascal.vranckx@jessazh.be
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Cardiology
Contact Person Name
Ian Buysschaert
Contact Person Email
Ian.Buysschaert@azsintjan.be
Site Name
CHU de Charleroi Hopital Civil Marie Curie
Department Name
Cardiology
Contact Person Name
Adel Aminian
Contact Person Email
adel.aminian@humani.be

Poland

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
22-09-2024
Processing Time Days
12
Number Of Sites
6
Number Of Participants
120

Sites

Site Name
Medical University of Gdańsk
Department Name
Cardiology
Contact Person Name
Miłosz J. Jaguszewski
Contact Person Email
mjaguszewski@gumed.edu.pl
Site Name
Szpital Kliniczny Uniwersytetu Medycznego
Department Name
Cardiology
Contact Person Name
Maciej Lesiak
Contact Person Email
maciej.lesiak@skpp.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Cardiology
Contact Person Name
Milos Dziarmaga
Contact Person Email
milosz.dziarmaga@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny W Opolu
Department Name
Cardiology
Contact Person Name
Jerzy Sacha
Contact Person Email
sacha@op.pl
Site Name
National Institute of Cardiology Warsaw
Department Name
Cardiology
Contact Person Name
Rafał Wolny
Contact Person Email
rafal.wolny@gmail.com
Site Name
Gornoslaskie Centrum Mwdyczne
Department Name
Cardiology
Contact Person Name
Wojciech Wojakowski
Contact Person Email
wwojakowski@sum.edu.pl

Netherlands

Earliest CTIS Part Ii Submission Date
13-01-2025
Latest Decision Or Authorization Date
27-01-2025
Processing Time Days
14
Number Of Sites
4
Number Of Participants
150

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Cardiology
Contact Person Name
Joanna Jadwiga Wykrzykowska
Contact Person Email
j.j.wykrzykowska@umcg.nl
Site Name
Catharina Ziekenhuis Eindhoven
Department Name
Cardiology
Contact Person Name
Pieter-Jan Vlaar
Site Name
Medisch Centrum Leeuwarden B.V.
Department Name
Cardiology
Contact Person Name
Sjoerd H. Hofma
Contact Person Email
s.h.hofma@mcl.nl
Site Name
Jeroen Bosch Hospital
Department Name
Cardiology
Contact Person Name
Jawed Polad
Contact Person Email
j.polad@jbz.nl

Germany

Earliest CTIS Part Ii Submission Date
29-08-2024
Latest Decision Or Authorization Date
09-09-2024
Processing Time Days
11
Number Of Sites
10
Number Of Participants
400

Sites

Site Name
Barmherzige Brueder Trier gGmbH
Department Name
Interventionelle Kardiologie
Contact Person Name
Jürgen Leick
Contact Person Email
j.leick@bbtgruppe.de
Site Name
Universitätsklinikum Frankfurt am Main
Department Name
Cardiology
Contact Person Name
David M. Leistner
Site Name
Segeberger Kliniken
Department Name
Cardiology
Contact Person Name
Holger Nef
Site Name
Klinikum Fürth
Department Name
Cardiology
Contact Person Name
Stylianos Pyxaras
Site Name
Universitätsklinikum Köln
Department Name
Cardiology
Contact Person Name
Marcel Halbach
Contact Person Email
marcel.halbach@uk-koeln.de
Site Name
LMU Klinikum München
Department Name
Cardiology
Contact Person Name
Steffen Massberg
Site Name
Klinikum Friedrichshafen GmbH
Department Name
Cardiology
Contact Person Name
Julia Seeger
Contact Person Email
seeger.julia@medizincampus.de
Site Name
Klinikum Landshut
Department Name
Cardiology
Contact Person Name
Julinda Mehilli
Contact Person Email
julinda.mehilli@lakumed.de
Site Name
Elisabeth-Krankenhaus Essen GmbH
Department Name
Heart and Vascular Center
Contact Person Name
Thomas Schmitz
Contact Person Email
t.schmitz@contilia.de
Site Name
ASKLEPIOS KLINIK Bad Oldesloe
Department Name
Internal Medicine & Cardiology
Contact Person Name
Ralph Ernst Tolg
Contact Person Email
r.toelg@askleoios.com

Spain

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
17-09-2024
Processing Time Days
5
Number Of Sites
16
Number Of Participants
230

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Cardiology
Contact Person Name
Manel Sabatè Tenas
Contact Person Email
masabate@clinic.cat
Site Name
Hospital Universitario La Paz
Department Name
Cardiology
Contact Person Name
Josè Raul Moreno Gomez
Contact Person Email
raulmorenog@hotmail.com
Site Name
Hospital Universitario Miguel Servet
Department Name
Cardiology
Contact Person Name
Josè Antonio Diarte De Miguel
Contact Person Email
jadiarte@salud.aragon.es
Site Name
Bellvitge University Hospital
Department Name
Cardiology
Contact Person Name
Joan Antonii Gomez Hospital
Contact Person Email
jagomezh@bellvitgehospital.cat
Site Name
Hospital Clinico Universitario De Valladolid
Department Name
Interventional Cardiology
Contact Person Name
Ignacio Jesus Amat-Santos
Contact Person Email
ijamat@gmail.com
Site Name
Hospital Virgen del Rocio
Department Name
Cardiology
Contact Person Name
Josè Francisco Diaz Fernandez
Site Name
Hospital Clinico San Carlos
Department Name
Interventional Cardiology
Contact Person Name
Nieves Gonzalo Lopez
Contact Person Email
nieves_gonzalo@yahoo.es
Site Name
Hospital de la Santa Creu y Sant Pau
Department Name
Cardiology
Contact Person Name
Dabit Arzamendi Aizpurua
Contact Person Email
dabitarza@gmail.com
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Cardiology
Contact Person Name
Juan Caballero Borrego
Contact Person Email
caballero.borrego@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Coronary Intervention
Contact Person Name
Josè Maria de la Torre Hernandez
Contact Person Email
josemariadela.torre@scsalud.es
Site Name
University Hospital Son Espases
Department Name
Cardiology
Contact Person Name
Vicente Peral Disdier
Contact Person Email
vpd8781@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Interventional Cardiology
Contact Person Name
Juan Sanchis Foréz
Contact Person Email
sanchis_juafor@gva.es
Site Name
Hospital Universitario Juan Ramon Jimenez
Department Name
Interventional Cardiology
Contact Person Name
Antonio Enrique Gómez Menchero
Contact Person Email
aegmenchero@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Cardiology
Contact Person Name
Jose Luis Diez Gil
Contact Person Email
diez_jlu@gva.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Cardiology
Contact Person Name
Cristobal Urbano Carrillo
Contact Person Email
cristobalurbano@gmail.com
Site Name
Hospital General Universitario Reina Sofia
Department Name
Cardiology
Contact Person Name
Soledad Ojeda Pineda
Contact Person Email
soledad.ojeda18@gmail.com

France

Earliest CTIS Part Ii Submission Date
09-09-2024
Latest Decision Or Authorization Date
19-09-2024
Processing Time Days
10
Number Of Sites
23
Number Of Participants
320

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
Interventional cardiology and coronary artery disease
Contact Person Name
Thomas Cuisset
Contact Person Email
thomas.cuisset@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Cardiology
Contact Person Name
Thibault Lhermusier
Contact Person Email
Lhermusier.t@chu-toulouse.fr
Site Name
Centre Hospitalier De Haguenau
Department Name
Cardiology
Contact Person Name
Fabien De Poli
Contact Person Email
fabien@ch-haguenau.fr
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Cardiology
Contact Person Name
Johanne Silvain
Contact Person Email
johanne.silvain@aphp.fr
Site Name
Polyclinique Les Fleurs
Department Name
Interventional cardiology
Contact Person Name
Eugenio La Scala
Contact Person Email
epflascala@hotmail.com
Site Name
Centre Hospitalier Annecy Genevois
Department Name
Interventional Cardiology
Contact Person Name
Marc Bonnet
Contact Person Email
mbonnet1@ch-annecygenevois.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Cardiology
Contact Person Name
Eric Van Belle
Contact Person Email
ericvanbelle@aol.com
Site Name
Besancon University Hospital Center
Department Name
Cardiology
Contact Person Name
Nicolas Meneveau
Site Name
Centre Hospitalier De Perpignan
Department Name
Cardiology
Contact Person Name
Pierre Sultan
Contact Person Email
pierre.sultan@ch-perpignan.fr
Site Name
Clinique Rhône Durance
Department Name
Cardiology
Contact Person Name
Jerome Brunet
Contact Person Email
jeromebrunet@cardiord.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Cardiology
Contact Person Name
Florence Leclercq
Contact Person Email
f-leclercq@chu-montpellier.fr
Site Name
Centre Hospitalier de Pau
Department Name
Cardiology
Contact Person Name
Nicolas Delarche
Contact Person Email
n.delarche@wanadoo.fr
Site Name
Hôpital privé Confluent
Department Name
Cardiology
Contact Person Name
Erwan Bressolette
Contact Person Email
bressolette@icloud.com
Site Name
Clinique Du Pont De Chaume
Department Name
Cardiology and Vascular Medicine
Contact Person Name
Thibautl Petroni
Contact Person Email
petroni.cardio@gmail.com
Site Name
Centre Hospitalier Universitaire de Nimes
Department Name
Cardiology
Contact Person Name
Guillaume Cayla
Contact Person Email
cayla.guillaume@gmail.com
Site Name
Clinique Saint Hilaire
Department Name
Cardiology
Contact Person Name
Matthieu Godin
Site Name
Clinique Axium
Department Name
Cardiology
Contact Person Name
Marc Silvestri
Contact Person Email
drmsilvestri@gmail.com
Site Name
CHU Gabriel-Montpied
Department Name
Cardiologie et medicine vasculaire
Contact Person Name
Geraud Souteyrand
Site Name
Clinique du Millenaire
Department Name
Cardiology
Contact Person Name
Christophe Piot
Contact Person Email
christophepiot21@gmail.com
Site Name
Clinique Pasteur
Department Name
Groupe CardioVasculaire Interventionnel
Contact Person Name
Benjamin Honton
Contact Person Email
bhonton@clinique-pasteur.com
Site Name
Hopital Prive Saint Martin-Caen
Department Name
Cardiology
Contact Person Name
Andrea Zuffi
Contact Person Email
zuffiandrea@hotmail.com
Site Name
GCS Axium-Rambot
Department Name
Interventional Cardiology
Contact Person Name
François Vochelet
Contact Person Email
francois.vochelet@gmail.com
Site Name
Institut Arnault Tzanck
Department Name
Cardiology
Contact Person Name
Julien ADJEDJ
Contact Person Email
j.adjedj@tzanck.org

Italy

Earliest CTIS Part Ii Submission Date
04-01-2024
Latest Decision Or Authorization Date
13-08-2024
Processing Time Days
222
Number Of Sites
27
Number Of Participants
340

Sites

Site Name
Fondazione Poliambulanza
Department Name
Cardiology
Contact Person Name
Andrea Zito
Contact Person Email
andrea.zito2@gmail.com
Site Name
Policlinico Umberto I
Department Name
Cardiologia Interventistica
Contact Person Name
Gennaro Sardella
Contact Person Email
rino.sardella@uniroma1.it
Site Name
Ospedale San Giovanni Bosco
Department Name
Cardiologia
Contact Person Name
Giacomo Boccuzzi
Contact Person Email
giacomo.boccuzzi@gmail.com
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
Cardiologia
Contact Person Name
Flavio Luciano Ribichini
Contact Person Email
flavio.ribichini@univr.it
Site Name
Ospedale Maggiore di Lodi
Department Name
Cardiologia
Contact Person Name
Pietro Mazzarotto
Contact Person Email
pietro.mazzarotto@asst-lodi.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
S.C. Emodinamica
Contact Person Name
Pietro Vandoni
Site Name
A.O.U. Città della Salute e dalla Scienza di Torino
Department Name
Cardiology
Contact Person Name
Pierluigi Omedè
Contact Person Email
pierluigi.omede@gmail.com
Site Name
A.O.U. Policlinico "G. Rodolicp-San Marco"
Department Name
Cardiology
Contact Person Name
Davide Capodanno
Contact Person Email
dcapodanno@gmail.com
Site Name
Ospèedale degli Infermi di Rivoli
Department Name
Cardiologia
Contact Person Name
Ferdinando Varbella
Contact Person Email
varbella@gmail.com
Site Name
Clinica Mediterranea
Department Name
Cardiologia
Contact Person Name
Carlo Briguori
Site Name
Ospedale Cardinal Massaia
Department Name
Cardiologia
Contact Person Name
Emanuele Meliga
Contact Person Email
emeliga@asl.at.it
Site Name
IRCCS Istituto Clinico Humanitas
Department Name
Cardiologia
Contact Person Name
Giulio Stefanini
Contact Person Email
giulio.stefanini@hunimed.eu
Site Name
Azienda Ospedaliera San'Anna e San Sebastiano di Caserta
Department Name
Cardiologia
Contact Person Name
Paolo Calabrò
Contact Person Email
paolo.calabro@unicampania.it
Site Name
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Department Name
Cardiologia Interventistica
Contact Person Name
Alfonso Ielasi
Contact Person Email
alfonso.ielasi@gmail.com
Site Name
Asieda Ospedaliero-Universitaria di Parma
Department Name
Cardiologia
Contact Person Name
Giampaolo Niccoli
Contact Person Email
giampaolo.niccoli@unipr.it
Site Name
IRCCS Ospedale Auxologico San Luca
Department Name
Cardiologia Interventistica
Contact Person Name
Davide Sala
Contact Person Email
d.sala@auxologico.it
Site Name
ASST Nord Milano-Ospedale Bassini
Department Name
Cardiologia
Contact Person Name
Anita Paggi
Contact Person Email
anita.paggi@gmail.com
Site Name
Ospedale Infermi di Rimini
Department Name
Cardiology
Contact Person Name
Filippo Ottani
Contact Person Email
filippo.ottani@auslromagna.it
Site Name
IRCCS Policlinico San Matteo
Department Name
Cardiologia Interventistica
Contact Person Name
Marco Ferlini
Contact Person Email
marco.ferlini@gmail.com
Site Name
Ospedale Sandro Pertini
Department Name
Cardiologia
Contact Person Name
Alessandro Sciahbasi
Contact Person Email
alessandro.sciahbasi@gmail.com
Site Name
Ospedale Santa Corona
Department Name
Cardiology
Contact Person Name
Chiara Bernelli
Contact Person Email
c.bernelli@asl2.liguria.it
Site Name
A.O.U. Gaetano Martino
Department Name
Cardiology
Contact Person Name
Giampiero Vizzari
Contact Person Email
giampiero.vizzari@polime.it
Site Name
Azienda Ospedaliera Universitaria di Ferrara
Department Name
cardiologia
Contact Person Name
Andrea Erriquez
Contact Person Email
andrea.erriquez90@gmail.com
Site Name
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Department Name
DEA
Contact Person Name
Lucia Marinucci
Site Name
Azienda Ospedaliera Regionale San Carlo
Department Name
Cardiology
Contact Person Name
Eugenio Stabile
Contact Person Email
eugeniostabile@gmail.com
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Interventional Cardiology Unit
Contact Person Name
Tommaso Piva
Site Name
Policlinico Casilino
Department Name
Cardiology
Contact Person Name
Michael Donahuè
Contact Person Email
Donahuemichael@hotmail.com

Sponsor

Primary sponsor

Full Name
Insel Gruppe AG
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Switzerland

Third parties

  • {"country":"","full_name":"SAHAJANAND MEDICAL TECHNOLOGIES IRELAND LIMITED","duties_or_roles":"Monetary support","organisation_type":""}
  • {"country":"Switzerland","full_name":"Insel Gruppe AG, University Hospital Bern, Department of Cardiology","duties_or_roles":"Monetary support","organisation_type":""}

Investigational products

Investigational Product Name
RIVAROXABAN
Active Substance
RIVAROXABAN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
20
Investigational Product Name
TICAGRELOR
Active Substance
TICAGRELOR
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
180
Investigational Product Name
PRASUGREL
Active Substance
PRASUGREL
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
10
Investigational Product Name
APIXABAN
Active Substance
APIXABAN
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Maximum Dose
10
Investigational Product Name
DABIGATRAN
Active Substance
DABIGATRAN
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Maximum Dose
300
Investigational Product Name
EDOXABAN
Active Substance
EDOXABAN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
60
Investigational Product Name
ACETYLSALICYLIC ACID
Active Substance
ACETYLSALICYLIC ACID
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
100
Investigational Product Name
CLOPIDOGREL
Active Substance
CLOPIDOGREL
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
75
Combination Treatment
Yes

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