Trial Condition(s):

Atrial fibrillation (AF)

Study to gather information about the proper dosing of the oral FXIa inhibitor BAY 2433334 and to compare the safety of the study drug to apixaban, a non-vitamin K oral anticoagulant (NOAC) in patients with irregular heartbeat (atrial fibrillation) that can lead to heart-related complications. (PACIFIC-AF)

Bayer Identifier:

19765

ClinicalTrials.gov Identifier:

NCT04218266

EudraCT Number:

2019-002365-35

Study Completed

Trial Purpose

The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works in patients with irregular heartbeat (atrial fibrillation) that can lead to blood clots, stroke and other heart-related complications. In addition researchers want to compare the safety of the study drug to apixaban, a non-vitamin K oral anticoagulant (NOAC) in patients with atrial fibrillation. This study is also done to learn how the drug in this study moves into, through and out of the body. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.
Apixaban, works by reducing the production of blood clotting factors in our body and thins the blood and is a so called non-vitamin K oral anticoagulant (NOAC). Thinning the blood can prevent you from blood clots which can cause a stroke.

Inclusion Criteria
- Participant must be 45 years of age or older at the time of signing the informed consent.
- Participant with AF documented by ECG evidence with
-- CHA2DS2-VASc score ≥ 2 if male or CHA2DS2-VASc score ≥ 3 if female
-- Indication for treatment with an oral anticoagulant in
--- any participant currently not treated with an oral anticoagulant (e.g. treatment naïve) or alternatively,
--- participant on a NOAC in case of at least one bleeding risk feature (history of a prior bleed within the last 12 months requiring medical attention and / or moderate renal dysfunction with eGFR 30-50 ml/min and / or current clinically indicated antiplatelet therapy with Acetylsalicylic acid(ASA) ≤ 100 mg)
- Written informed consent
Exclusion Criteria
- Mechanical heart valve prosthesis 
- Any degree of rheumatic mitral stenosis or moderate-to-severe, non-rheumatic mitral stenosis
- Atrial fibrillation due to a reversible cause, participants in sinus rhythm after successful ablation, or plan for cardioversion or ablation during study conduct
- Requirement for chronic anticoagulation (for a different indication than AF) or antiplatelet therapy (up to 100 mg ASA is allowed). Anticipated need for chronic therapy with Nonsteroidal anti-inflammatory drugs (NSAIDs)
- Treated with a Vitamin K antagonist in the 30 days prior to screening

Trial Summary

Enrollment Goal
753
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Asundexian (BAY2433334)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Krajska nemocnice T. Bati, a.s.

Zlin, Czech Republic, 762 75

Status
Completed
 
Locations

Nemocnice Slany

Slany, Czech Republic, 274 01

Status
Completed
 
Locations

Universitätsspital Basel

Basel, Switzerland, 4031

Status
Completed
 
Locations

Inselspital Universitätsspital Bern

Bern, Switzerland, 3010

Status
Completed
 
Locations

Kantonsspital St. Gallen

St. Gallen, Switzerland, 9007

Status
Completed
 
Locations

Kantonsspital Aarau

Aarau, Switzerland, 5001

Status
Completed
 
Locations

Ospedale regionale di Lugano

Lugano, Switzerland, 6900

Status
Completed
 
Locations

Hôpital Cantonal Universitaire de Genève

Genève, Switzerland, 1211

Status
Completed
 
Locations

Jessa Ziekenhuis

HASSELT, Belgium, 3500

Status
Completed
 
Locations

AZ St-Jan Brugge Oostende AV

BRUGGE, Belgium, 8000

Status
Completed
 
Locations

Imeldaziekenhuis - St-Elisabethkliniek

BONHEIDEN, Belgium, 2820

Status
Completed
 
Locations

UZ Antwerpen

EDEGEM, Belgium, 2650

Status
Completed
 
Locations

VZW Emmaus

MECHELEN, Belgium, 2800

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Completed
 
Locations

Hospital Virgen de la Victoria

Málaga, Spain, 29010

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Hospital de la Santa Creu i de Sant Pau | Cardiología

Barcelona, Spain, 08041

Status
Completed
 
Locations

AZ Delta

ROESELARE, Belgium, 8800

Status
Completed
 
Locations

Heart and Chest Hospital

Liverpool, United Kingdom, L14 3PE

Status
Completed
 
Locations

Staploe Medical Centre

Ely, United Kingdom, CB7 5SQ

Status
Completed
 
Locations

Queen Elizabeth II Hospital

Welwyn Garden City, United Kingdom, AL7 4HQ

Status
Completed
 
Locations

Northwick Park Hospital

Harrow, United Kingdom, HA1 3UJ

Status
Completed
 
Locations

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, Hungary

Status
Completed
 
Locations

Tolna Megyei Balassa Janos Korhaz

Szekszard, Hungary, 7100

Status
Completed
 
Locations

Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz

Szentes, Hungary, 6600

Status
Completed
 
Locations

Kanizsai Dorottya Hospital

Nagykanizsa, Hungary, 8800

Status
Completed
 
Locations

University of Semmelweis/ Semmelweis Egyetem

Budapest, Hungary, 1122

Status
Completed
 
Locations

Pecsi Tudomanyegyetem Klinikai Kozpont

Pecs, Hungary, 7624

Status
Completed
 
Locations

Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.

Nyiregyhaza, Hungary, 4400

Status
Completed
 
Locations

Clinique Sante Cardio MC

Montreal, Canada, H1T 3Y7

Status
Completed
 
Locations

Institut universitaire de cardiologie et de pneumologie

Ste-Foy, Canada, G1V 4G5

Status
Completed
 
Locations

Fakultni nemocnice Kralovske Vinohrady

Praha 10, Czech Republic, 100 34

Status
Completed
 
Locations

Institut Klinicke a Experimentalni Mediciny

Praha 4, Czech Republic, 140 21

Status
Completed
 
Locations

Fakultni nemocnice Plzen - Lochotin

Plzen, Czech Republic, 304 60

Status
Completed
 
Locations

Fakultni nemocnice v Motole

Praha 5, Czech Republic, 150 06

Status
Completed
 
Locations

Liepaja Regional Hospital

Liepaja, Latvia, LV-3414

Status
Completed
 
Locations

1st Riga Clinical Hospital

Riga, Latvia, LV-1001

Status
Completed
 
Locations

P. Stradins Clinical University Hospital

Riga, Latvia, LV-1002

Status
Completed
 
Locations

Daugavpils Regional Hospital

Daugavpils, Latvia, LV-5417

Status
Completed
 
Locations

Riga East Clinical University Hospital "Gailezers"

Riga, Latvia, LV-1038

Status
Completed
 
Locations

Doctor's Practice in Cardiology

Daugavpils, Latvia, LV-5401

Status
Completed
 
Locations

AUSL Toscana Sud-Est

Arezzo, Italy, 52100

Status
Completed
 
Locations

AUSL Toscana Sud-Est

Arezzo, Italy, 52044

Status
Completed
 
Locations

A.O. di Perugia

Perugia, Italy, 06129

Status
Completed
 
Locations

ASUR Marche - Area Vasta 5

Ascoli Piceno, Italy, 63074

Status
Completed
 
Locations

IRCCS Ospedale Policlinico San Martino

Genova, Italy, 16132

Status
Completed
 
Locations

ASST Spedali Civili di Brescia

Brescia, Italy, 25123

Status
Completed
 
Locations

A.O.U. Policlinico Umberto I

Roma, Italy, 00161

Status
Completed
 
Locations

Krankenhaus St. Josef Braunau

Braunau, Austria, 5280

Status
Completed
 
Locations

Klinik Floridsdorf - Krankenhaus Nord

Wien, Austria, 1210

Status
Completed
 
Locations

Landeskrankenhaus Feldkirch

Feldkirch, Austria, 6807

Status
Completed
 
Locations

Uniklinikum Salzburg - Landeskrankenhaus

Salzburg, Austria, 5020

Status
Completed
 
Locations

Universitätsklinikum AKH Wien

Wien, Austria, 1090

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Medizinische Universität Innsbruck

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Ordensklinikum Linz GmbH Elisabethinen

Linz, Austria, 4020

Status
Completed
 
Locations

Hôpital Henri Mondor

CRETEIL, France, 94010

Status
Completed
 
Locations

Centre Hospitalier Régional - Saint Brieuc

SAINT BRIEUC, France, 22000

Status
Completed
 
Locations

Centre Hospitalier Départemental Vendée

LA ROCHE SUR YON CEDEX, France, 85025

Status
Completed
 
Locations

Centre Hospitalier Louis Pasteur

LE COUDRAY, France, 28630

Status
Completed
 
Locations

Hopital Bichat - Paris

PARIS, France, 75018

Status
Completed
 
Locations

Centre Hospitalier - Valenciennes Cedex

VALENCIENNES CEDEX, France, 59322

Status
Completed
 
Locations

Hôpital de Rangueil - Toulouse

TOULOUSE, France, 31403

Status
Completed
 
Locations

Queen Elizabeth II Health Sciences Centre

Halifax, Canada, B3H 3A7

Status
Completed
 
Locations

Montreal Heart Institute

Montreal, Canada, H1T 1C8

Status
Completed
 
Locations

Clemenstorget Hjärtmottagning

Lund, Sweden, 222 21

Status
Completed
 
Locations

Danderyds sjukhus

Stockholm, Sweden, 182 88

Status
Completed
 
Locations

Avdelningen för kliniska prövningar AKP

Örebro, Sweden, 703 62

Status
Completed
 
Locations

Södersjukhuset AB

Stockholm, Sweden, 118 83

Status
Completed
 
Locations

Skellefteå Lasarett

Skellefteå, Sweden, 931 86

Status
Completed
 
Locations

Falu Lasarett

Falun, Sweden, 791 82

Status
Completed
 
Locations

Östersunds Sjukhus

Östersund, Sweden, 831 83

Status
Completed
 
Locations

Koto Hospital

Koto-ku, Japan, 136-0072

Status
Completed
 
Locations

Kishiwada Tokushukai Hospital

Kishiwada, Japan, 596-0042

Status
Completed
 
Locations

Nishiarai Heart Central Clinic

Adachi-ku, Japan, 123-0845

Status
Completed
 
Locations

Nakamura Cardiovascular Clinic

Itoshima, Japan, 819-1104

Status
Completed
 
Locations

Hyogo Prefectural Harima-Himeji General Medical Center

Himeji, Japan, 670-8560

Status
Completed
 
Locations

Tokyo Angel Hospital

Hachioji, Japan, 193-0811

Status
Completed
 
Locations

Hayama Heart Center

Miura-gun, Japan, 240-0116

Status
Completed
 
Locations

Yao Tokushukai General Hospital

Yao, Japan, 581-0011

Status
Completed
 
Locations

Minamino Cardiovascular Hospital

Hachioji, Japan, 192-0918

Status
Completed
 
Locations

Academisch Medisch Centrum (AMC)

AMSTERDAM, Netherlands, 1105 AZ

Status
Completed
 
Locations

Maastricht UMC

MAASTRICHT, Netherlands, 6229 HX

Status
Completed
 
Locations

Amphia Ziekenhuis, locatie Molengracht

BREDA, Netherlands, 4818 CK

Status
Completed
 
Locations

Martini Ziekenhuis, Locatie van Swieten

GRONINGEN, Netherlands, 9728 NT

Status
Completed
 
Locations

Ziekenhuis Rijnstate

ARNHEM, Netherlands, 6815 AD

Status
Completed
 
Locations

Spaarne Gasthuis - locatie Zuid

HAARLEM, Netherlands, 2035 RC

Status
Completed
 
Locations

Albert Schweitzer Ziekenhuis, Dordwijk

DORDRECHT, Netherlands, 3318 AT

Status
Completed
 
Locations

Medisch Spectrum Twente

ENSCHEDE, Netherlands, 7511 JX

Status
Completed
 
Locations

St Richard's Hospital

Chichester, United Kingdom, PO19 6SE

Status
Completed
 
Locations

Tagore Medical Center

Balatonfured, Hungary, 8230

Status
Completed
 

Trial Design