Clinical trial • Phase IV • Cardiology

APIXABAN for Atrial fibrillation

Phase IV trial of APIXABAN for Atrial fibrillation.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Atrial fibrillation
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
05-12-2023
First CTIS Authorization Date
29-01-2024

Trial design

Randomised, no anticoagulation (control). active interventions (approved noacs) include apixaban (reported max daily amounts: 2.5 mg and 5 mg, oral), rivaroxaban (reported max daily amounts: 15 mg and 20 mg, oral), edoxaban (reported max daily amounts: 30 mg and 60 mg, oral), dabigatran (reported max daily amount: 110 mg, oral). Phase IV trial in Denmark, Netherlands, Sweden and others.

Randomised
Yes
Comparator
No anticoagulation (control). Active interventions (approved NOACs) include Apixaban (reported max daily amounts: 2.5 mg and 5 mg, oral), Rivaroxaban (reported max daily amounts: 15 mg and 20 mg, oral), Edoxaban (reported max daily amounts: 30 mg and 60 mg, oral), Dabigatran (reported max daily amount: 110 mg, oral).
Target Sample Size
1660

Eligibility

Recruits 1660 The CTIS record indicates isVulnerablePopulationSelected = true. Inclusion requires "Provide written informed consent to participate". Subject information and informed consent forms (ICFs) are provided per country (country-specific ICF documents available); ICFs referenced include adult ICFs. No specific assent or parental consent procedures are described in the available CTIS data..

Pregnancy Exclusion
Are women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception
Vulnerable Population
The CTIS record indicates isVulnerablePopulationSelected = true. Inclusion requires "Provide written informed consent to participate". Subject information and informed consent forms (ICFs) are provided per country (country-specific ICF documents available); ICFs referenced include adult ICFs. No specific assent or parental consent procedures are described in the available CTIS data.

Inclusion criteria

  • {"criterion_text":"- have at least 1 episode of clinically important AFOTS during any of the following conditions: noncardiac surgery in the past 35 days, with at least an overnight hospital admission after surgery; noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or acute medical illness requiring hospital admission in the past 35 days and resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator"}
  • {"criterion_text":"- Are in sinus rhythm at the time of randomization"}
  • {"criterion_text":"- Meet any of the following high-risk criteria; (1) age 55-64 years, and having either established cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥ 3, or an elevated postoperative troponin level; (2) age 65-74 years, and having either established cardiovascular disease, recent vascular surgery, a CHA2DS2VASc score ≥ 2, or an elevated postoperative troponin level; or (3) age ≥ 75 years"}
  • {"criterion_text":"- Provide written informed consent to participate"}

Exclusion criteria

  • {"criterion_text":"- Have a history of documented chronic (i.e., non-transient) AF prior to noncardiac surgery. For example, the following patients will still be considered eligible for this trial: (1) a history of subclinical AF only (i.e., AF episodes only documented by pacemakers or similar devices); (2) a previous history of perioperative AF only (after cardiac or noncardiac surgery); or (3) patients with a previous history of transient AF after medical stress (e.g., sepsis, uncontrolled hyperthyroidism)"}
  • {"criterion_text":"- Have an ongoing need for long-term dual antiplatelet treatment"}
  • {"criterion_text":"- Have a contraindication to oral anticoagulation"}
  • {"criterion_text":"- Have severe renal insufficiency (CrCl < 20 ml/min)"}
  • {"criterion_text":"- Have had an acute stroke in the past 14 days"}
  • {"criterion_text":"- any cardiac diagnosis as the primary reason for hospital admission (e.g., acute coronary syndrome, congestive heart failure, peri-myocarditis)"}
  • {"criterion_text":"- Have had cardiac surgery in the past 35 days"}
  • {"criterion_text":"- Have a history of nontraumatic intracranial, intraocular, or spinal bleeding"}
  • {"criterion_text":"- Are expected to be non-compliant with follow-up and/or study medications"}
  • {"criterion_text":"- Have severe liver cirrhosis (i.e., Child-Pugh Class C)"}
  • {"criterion_text":"- Have a known life expectancy less than one year due to concomitant disease"}
  • {"criterion_text":"- Are women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception"}
  • {"criterion_text":"- Were previously enrolled in the trial"}
  • {"criterion_text":"- Need for long-term systemic anticoagulation (e.g., pre-existing AF, mechanical heart valve, antiphospholipid syndrome with a history of thrombosis))"}
  • {"criterion_text":"- hemorrhagic disorder or bleeding diathesis"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Individual components of the co-primary outcomes","definition_or_measurement_approach":"Components are defined as elements of the co-primary composite outcomes described in the main objective (e.g., non-hemorrhagic stroke and systemic embolism; vascular mortality; non-fatal non-hemorrhagic stroke; myocardial infarction; peripheral arterial thrombosis; amputation; symptomatic venous thromboembolism) assessed over the duration of follow-up."}
  • {"endpoint_text":"- All stroke","definition_or_measurement_approach":"Incidence of all stroke events during the duration of follow-up (as listed among primary endpoints)."}
  • {"endpoint_text":"- All-cause mortality","definition_or_measurement_approach":"Incidence of death from any cause during the duration of follow-up."}

Recruitment

Planned Sample Size
1660
Recruitment Window Months
91
Consent Approach
Written informed consent is required: inclusion criterion states "Provide written informed consent to participate". Subject information and informed consent forms (ICFs) are available per country (country-specific ICF documents listed, including adult ICFs and local language versions such as Danish, Italian, Spanish, Swedish, Greek, Dutch, Finnish, Belgian versions). No specific mention of assent or parental consent in the CTIS data.

Geography

Total Number Of Sites
47
Total Number Of Participants
969

Denmark

Earliest CTIS Part Ii Submission Date
11-01-2024
Latest Decision Or Authorization Date
30-01-2024
Processing Time Days
19
Number Of Sites
3
Number Of Participants
70

Sites

Site Name
Hospital South West Jutland - University Hospital of Southern Denmark
Department Name
Cardiology
Contact Person Name
Axel Brandes
Contact Person Email
axel.brandes2@rsyd.dk
Site Name
Aarhus University Hospital
Department Name
Cardiology
Contact Person Name
Erik Grove
Contact Person Email
erikgrov@rm.dk
Site Name
Odense University Hospital
Department Name
Cardiology
Contact Person Name
Gro Egholm
Contact Person Email
gro.egholm@rsyd.dk

Netherlands

Earliest CTIS Part Ii Submission Date
11-01-2024
Latest Decision Or Authorization Date
29-01-2024
Processing Time Days
18
Number Of Sites
12
Number Of Participants
240

Sites

Site Name
Jeroen Bosch Hospital
Department Name
Cardiology
Contact Person Name
Jacob Van Eck
Contact Person Email
m.v.eck@jbz.nl
Site Name
Ziekenhuis Amstelland
Department Name
Cardiology
Contact Person Name
Freerk Broeyer
Contact Person Email
f.broeyer@zha.nl
Site Name
Deventer Ziekenhuis
Department Name
Cardiology
Contact Person Name
Ype Tuininga
Contact Person Email
y.tuininga@dz.nl
Site Name
Amphia Ziekenhuis te Breda
Department Name
Cardiology
Contact Person Name
Marco Alings
Contact Person Email
rdcardio@amphia.nl
Site Name
ZiekenhuisGroepTwente
Department Name
Cardiology
Contact Person Name
Lambertus Pos
Contact Person Email
l.pos@zgt.nl
Site Name
Ikazia Hospital
Department Name
Cardiology
Contact Person Name
Stieneke Zoet-Nugteren
Contact Person Email
researchcardiologie@ikazia.nl
Site Name
Hospital Gelderse Vallei
Department Name
Cardiology
Contact Person Name
Thomas Oosterhof
Contact Person Email
oosterhoft@zgv.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Cardiology
Contact Person Name
Ron Pisters
Contact Person Email
cardioresearch@rijnstate.nl
Site Name
Stichting Martini Ziekenhuis
Department Name
Cardiology
Contact Person Name
Robert Tieleman
Contact Person Email
r.tieleman@mzh.nl
Site Name
Noordwest Ziekenhuisgroep Stichting
Department Name
Cardiology
Contact Person Name
Stefan Timmer
Contact Person Email
saj.timmer@nwz.nl
Site Name
ETZ Tilburg
Department Name
Cardiology
Contact Person Name
Walter Hermans
Contact Person Email
wrm.hermans@etz.nl
Site Name
Sint Franciscus Vlietland Groep Stichting
Department Name
Cardiology
Contact Person Name
Peter Nierop

Sweden

Earliest CTIS Part Ii Submission Date
11-01-2024
Latest Decision Or Authorization Date
31-01-2024
Processing Time Days
20
Number Of Sites
3
Number Of Participants
70

Sites

Site Name
Norrlands University Hospital
Department Name
Cardiology
Contact Person Name
Ioannis Katsoularis
Site Name
Karolinska Institutet Danderyds Hospital
Department Name
Cardiology
Contact Person Name
Piotr Sobocinski Doliwa
Site Name
Uppsala University
Department Name
Cardiology
Contact Person Name
Gorav Batra
Contact Person Email
gorav.batra@ucr.uu.se

Italy

Earliest CTIS Part Ii Submission Date
11-01-2024
Latest Decision Or Authorization Date
01-02-2024
Processing Time Days
21
Number Of Sites
7
Number Of Participants
110

Sites

Site Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Department Name
Anesthesiology, Intensive Care and Emergency
Contact Person Name
Giuseppe Ristagno
Contact Person Email
giuseppe.ristagno@unimi.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Cardiology
Contact Person Name
Matteo Baroni
Site Name
SOC Medicina Interna I – Azienda USL Toscana Centro
Department Name
Internal Medicine
Contact Person Name
Roberto Tarquini
Site Name
IRCCS Humanitas Research Hospital
Department Name
Internal Medicine
Contact Person Name
Maura Marcucci
Contact Person Email
maura.marcucci@hunimed.eu
Site Name
Azienda Unita Sanitaria Locale Di Piacenza
Department Name
Cardiology
Contact Person Name
Maria Giulia Bolognesi
Contact Person Email
m.bolognesi@ausl.pc.it
Site Name
A.O.SS Antonio Biagio e Cesare Arrigo Alessandria
Department Name
Emergency Surgery
Contact Person Name
Ferruccio Ravazzoni
Contact Person Email
fravazzoni@ospedale.al.it
Site Name
La Maddalena S.p.A.
Department Name
Surgical Oncology
Contact Person Name
Salvatore D'Arpa

Spain

Earliest CTIS Part Ii Submission Date
11-01-2024
Latest Decision Or Authorization Date
30-01-2024
Processing Time Days
19
Number Of Sites
7
Number Of Participants
120

Sites

Site Name
Hospital Universitario de Navarra
Department Name
Cardiology
Contact Person Name
Oscar Alcalde
Contact Person Email
37053oar@gmail.com
Site Name
University Hospital Ramon y Cajal
Department Name
Cardiology
Contact Person Name
Jesus Alvarez Garcia
Contact Person Email
jalvarezg82@gmail.com
Site Name
Hospital del Mar
Department Name
Anesthesiology
Contact Person Name
Sandra Beltran de Heredia Marrodan
Contact Person Email
sbeltrand@psmar.cat
Site Name
Vall d'Hebron Hospital
Department Name
Anesthesiology
Contact Person Name
Montserrat Ribas Ball
Site Name
Hospital de la Santa Creu i Sant Pau
Department Name
Cardiology
Contact Person Name
Jose Guerra
Contact Person Email
jguerra@santpau.cat
Site Name
Hospital Universitario Mutua Terrassa
Department Name
Cardiology
Contact Person Name
Beatriz Toledano Leon
Contact Person Email
btoledano@mutuaterrassa.cat
Site Name
Corporacio Sanitaria Parc Tauli
Department Name
Cardiology
Contact Person Name
Victor Garcia Hernando
Contact Person Email
vgarciah@tauli.cat

Finland

Earliest CTIS Part Ii Submission Date
01-11-2024
Latest Decision Or Authorization Date
22-11-2024
Processing Time Days
21
Number Of Sites
3
Number Of Participants
60

Sites

Site Name
Southwest Finland Wellbeing County (VARHA)
Department Name
Heart Centre
Contact Person Name
Tuomas Kiviniemi
Contact Person Email
tuoski@utu.fi
Site Name
Satasairaala
Department Name
Heart Unit
Contact Person Name
Jussi Jaakkola
Contact Person Email
jussi.jaakkola@sata.fi
Site Name
Oulu University Hospital
Department Name
Heart Centre
Contact Person Name
Juhani Junttila
Contact Person Email
juhani.junttila@oulu.fi

Germany

Earliest CTIS Part Ii Submission Date
05-11-2024
Latest Decision Or Authorization Date
18-12-2024
Processing Time Days
43
Number Of Sites
1
Number Of Participants
65

Sites

Site Name
Universitatsklinikum Leipzig
Department Name
Cardiology
Contact Person Name
Rolf Wachter

Belgium

Earliest CTIS Part Ii Submission Date
03-02-2025
Latest Decision Or Authorization Date
14-02-2025
Processing Time Days
11
Number Of Sites
2
Number Of Participants
30

Sites

Site Name
University Hospitals Leuven
Department Name
Cardiology
Contact Person Name
Thomas Vanassche
Contact Person Email
thomas.vanassche@uzleuven.be
Site Name
Cliniques du Sud Luxebourg - VIVALIA Arlon
Department Name
Cardiology
Contact Person Name
Georges Mairesse
Contact Person Email
georges.mairesse@vivalia.be

Greece

Earliest CTIS Part Ii Submission Date
25-04-2025
Latest Decision Or Authorization Date
02-05-2025
Processing Time Days
7
Number Of Sites
5
Number Of Participants
180

Sites

Site Name
“Sotiria” Chest Disease Hospital, Medical School, National and Kapodistrian University of Athens
Department Name
3rd Cardiology Department
Contact Person Name
Evangelos Oikonomou
Contact Person Email
gpkkdk@0315.syzefxis.gov.gr
Site Name
Ippokratio General Hospital of Thessaloniki, Aristotle University of Thessaloniki
Department Name
3rd Cardiology Department
Contact Person Name
Vasileios Vasilikos
Contact Person Email
3rdcardio@gmail.com
Site Name
Attikon University Hospital
Department Name
Cardiology
Contact Person Name
Gerasimos Filippatos
Contact Person Email
gfilippatos@gmail.com
Site Name
Aretaieio Hospital, National and Kapodistrian University of Athens
Department Name
Second Department of Surgery
Contact Person Name
Dorothea Tsekoura
Contact Person Email
dtsekoura@med.uoa.gr
Site Name
Aristotle University of Thessaloniki, Hippokration General Hospital
Department Name
Second Cardiology
Contact Person Name
Nikolaos Fragakis
Contact Person Email
fragkis.nikos@gmail.com

Norway

Earliest CTIS Part Ii Submission Date
11-03-2026
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
15
Number Of Sites
4
Number Of Participants
24

Sites

Site Name
Akershus University Hospital
Department Name
Cardiology
Contact Person Name
Henrik Schirmer
Contact Person Email
Henrik.Schirmer@medisin.uio.no
Site Name
Baerum Sykehus
Department Name
Internal Medicine
Contact Person Name
Marius Myrstad
Contact Person Email
marius.myrstad@vestreviken.no
Site Name
Oslo Universitetssykehus HF
Department Name
Cardiology
Contact Person Name
Oyvind Lie
Contact Person Email
B28176@ous-hf.no
Site Name
Drammen Sykehus
Department Name
Cardiology
Contact Person Name
Jonas Pivoriunas

Sponsor

Primary sponsor

Full Name
Hamilton Health Sciences Corporation
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Canada

Contract research organisations

Name
Pharmassist Ltd.
Responsibilities
sponsorDuties codes: 12, 5; contact email g.kalkounou@pharmassist-cro.com; phone 302106560700

Third parties

  • {"country":"Greece","full_name":"Pharmassist Ltd.","duties_or_roles":"sponsorDuties codes: 12, 5; contact g.kalkounou@pharmassist-cro.com","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
APIXABAN
Active Substance
APIXABAN
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
prodAuthStatus: 2
Dose Levels
2.5 mg | 5 mg
Maximum Dose
5 mg
Investigational Product Name
RIVAROXABAN
Active Substance
RIVAROXABAN
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
prodAuthStatus: 2
Dose Levels
15 mg | 20 mg
Maximum Dose
20 mg
Investigational Product Name
EDOXABAN
Active Substance
EDOXABAN
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
prodAuthStatus: 2
Dose Levels
30 mg | 60 mg
Maximum Dose
60 mg
Investigational Product Name
DABIGATRAN
Active Substance
DABIGATRAN
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
prodAuthStatus: 2
Dose Levels
110 mg
Maximum Dose
110 mg

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