Study Completed

Atrial fibrillation (AF)

Bayer Identifier:

19765

ClinicalTrials.gov Identifier:

NCT04218266

EudraCT Number:

2019-002365-35

EU CT Number:

Not Available

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.

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.

Key Participants Requirements

Sex

All

Age

45 - N/A

Trial summary

Enrollment Goal

755

Trial Dates

January 2020 - October 2021

Phase

Phase 2

Could I Receive a placebo

Products

Asundexian (BAY2433334)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Krajska nemocnice T. Bati, a.s.	Zlin, 762 75, Czechia
Completed	Nemocnice Slany	Slany, 274 01, Czechia
Completed	Universitätsspital Basel	Basel, 4031, Switzerland
Completed	Inselspital Universitätsspital Bern	Bern, 3010, Switzerland
Withdrawn	Kantonsspital Winterthur	Winterthur, 8401, Switzerland
Completed	Kantonsspital St. Gallen	St. Gallen, 9007, Switzerland
Completed	Kantonsspital Aarau	Aarau, 5001, Switzerland
Withdrawn	Luzerner Kantonsspital	Luzern, 6000, Switzerland
Completed	Ospedale regionale di Lugano	Lugano, 6900, Switzerland
Completed	Hôpital Cantonal Universitaire de Genève	Genève, 1211, Switzerland
Completed	Jessa Ziekenhuis	HASSELT, 3500, Belgium
Completed	AZ St-Jan Brugge Oostende AV	BRUGGE, 8000, Belgium
Completed	Imeldaziekenhuis - St-Elisabethkliniek	BONHEIDEN, 2820, Belgium
Completed	UZ Antwerpen	EDEGEM, 2650, Belgium
Completed	VZW Emmaus	MECHELEN, 2800, Belgium
Completed	UZ Leuven Gasthuisberg	LEUVEN, 3000, Belgium
Withdrawn	Hospital Arnau de Vilanova de Valencia	Valencia, 46015, Spain
Completed	Ciutat Sanitària i Universitària de Bellvitge	L'Hospitalet de Llobregat, 08907, Spain
Completed	Hospital Universitario 12 de Octubre	Madrid, 28041, Spain
Completed	Hospital Virgen de la Victoria	Málaga, 29010, Spain
Withdrawn	Hospital del Mar	Barcelona, 08003, Spain
Completed	Ciutat Sanitària i Universitaria de la Vall d'Hebron	Barcelona, 08035, Spain
Withdrawn	Hospital Ramon y Cajal \| Cardiologia	Madrid, 28034, Spain
Completed	Hospital de la Santa Creu i de Sant Pau \| Cardiología	Barcelona, 08041, Spain
Completed	AZ Delta	ROESELARE, 8800, Belgium
Completed	Heart and Chest Hospital	Liverpool, L14 3PE, United Kingdom
Completed	Staploe Medical Centre	Ely, CB7 5SQ, United Kingdom
Completed	Queen Elizabeth II Hospital	Welwyn Garden City, AL7 4HQ, United Kingdom
Withdrawn	Chesterfield Royal Hospital	Chesterfield, S44 5DX, United Kingdom
Completed	Northwick Park Hospital	Harrow, HA1 3UJ, United Kingdom
Withdrawn	University Hospital of Wales	Cardiff, CF14 4XW, United Kingdom
Withdrawn	Royal Cornwall Hospital	Truro, TR1 3LJ, United Kingdom
Completed	Magyar Honvedseg Egeszsegugyi Kozpont	Budapest, Hungary
Completed	Tolna Megyei Balassa Janos Korhaz	Szekszard, 7100, Hungary
Completed	Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz	Szentes, 6600, Hungary
Completed	Kanizsai Dorottya Hospital	Nagykanizsa, 8800, Hungary
Completed	University of Semmelweis/ Semmelweis Egyetem	Budapest, 1122, Hungary
Completed	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs, 7624, Hungary
Withdrawn	Magyar Honvedseg Egeszsegugyi Kozpont	Budapest, 1134, Hungary
Completed	Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.	Nyiregyhaza, 4400, Hungary
Withdrawn	Hamilton Health Sciences	Hamilton, L8L2X2, Canada
Completed	Clinique Sante Cardio MC	Montreal, H1T 3Y7, Canada
Withdrawn	Royal Alexandra Hospital	Edmonton, T5H 3V9, Canada
Withdrawn	St. Michael's Hospital Health Centre	Toronto, M5B 1W8, Canada
Withdrawn	Cambridge Cardiac Care Center	Cambridge, N1R 6V6, Canada
Completed	Institut universitaire de cardiologie et de pneumologie	Ste-Foy, G1V 4G5, Canada
Completed	Fakultni nemocnice Kralovske Vinohrady	Praha 10, 100 34, Czechia
Completed	Institut Klinicke a Experimentalni Mediciny	Praha 4, 140 21, Czechia
Withdrawn	Oblastni Nemocnice Kladno	Kladno, 27259, Czechia
Completed	Fakultni nemocnice Plzen - Lochotin	Plzen, 304 60, Czechia
Withdrawn	Nemocnice Pardubickeho kraje a.s., Orlickoustecka nemocnice	Usti nad Orlici, 56218, Czechia
Completed	Fakultni nemocnice v Motole	Praha 5, 150 06, Czechia
Withdrawn	Ventspils Hospital	Ventspils, LV-3601, Latvia
Completed	Liepaja Regional Hospital	Liepaja, LV-3414, Latvia
Completed	1st Riga Clinical Hospital	Riga, LV-1001, Latvia
Completed	P. Stradins Clinical University Hospital	Riga, LV-1002, Latvia
Completed	Daugavpils Regional Hospital	Daugavpils, LV-5417, Latvia
Completed	Riga East Clinical University Hospital "Gailezers"	Riga, LV-1038, Latvia
Completed	Doctor's Practice in Cardiology	Daugavpils, LV-5401, Latvia
Completed	Riga East Clinical University Hospital "Gailezers"	Riga, LV-1038, Latvia
Completed	AUSL Toscana Sud-Est	Arezzo, 52100, Italy
Completed	AUSL Toscana Sud-Est	Arezzo, 52044, Italy
Completed	A.O. di Perugia	Perugia, 06129, Italy
Completed	ASUR Marche - Area Vasta 5	Ascoli Piceno, 63074, Italy
Completed	IRCCS Ospedale Policlinico San Martino	Genova, 16132, Italy
Completed	ASST Spedali Civili di Brescia	Brescia, 25123, Italy
Withdrawn	A.O. Ospedali Riuniti Villa Sofia-Cervello	Palermo, 90146, Italy
Completed	A.O.U. Policlinico Umberto I	Roma, 00161, Italy
Completed	Krankenhaus St. Josef Braunau	Braunau, 5280, Austria
Completed	Klinik Floridsdorf - Krankenhaus Nord	Wien, 1210, Austria
Completed	Landeskrankenhaus Feldkirch	Feldkirch, 6807, Austria
Completed	Uniklinikum Salzburg - Landeskrankenhaus	Salzburg, 5020, Austria
Completed	Universitätsklinikum AKH Wien	Wien, 1090, Austria
Completed	Medizinische Universität Graz	Graz, 8036, Austria
Completed	Medizinische Universität Innsbruck	Innsbruck, 6020, Austria
Completed	Ordensklinikum Linz GmbH Elisabethinen	Linz, 4020, Austria
Completed	Hôpital Henri Mondor	CRETEIL, 94010, France
Completed	Centre Hospitalier Régional - Saint Brieuc	SAINT BRIEUC, 22000, France
Completed	Centre Hospitalier Départemental Vendée	LA ROCHE SUR YON CEDEX, 85025, France
Completed	Centre Hospitalier Louis Pasteur	LE COUDRAY, 28630, France
Completed	Hopital Bichat - Paris	PARIS, 75018, France
Completed	Centre Hospitalier - Valenciennes Cedex	VALENCIENNES CEDEX, 59322, France
Completed	Hôpital de Rangueil - Toulouse	TOULOUSE, 31403, France
Withdrawn	Hopital de Cardiologie - Lille	LILLE cedex, 59037, France
Completed	Queen Elizabeth II Health Sciences Centre	Halifax, B3H 3A7, Canada
Completed	Montreal Heart Institute	Montreal, H1T 1C8, Canada
Withdrawn	H. Hartziekenhuis Mol	MOL, 2400, Belgium
Withdrawn	SU/Östra	Göteborg, 416 85, Sweden
Completed	Clemenstorget Hjärtmottagning	Lund, 222 21, Sweden
Completed	Danderyds sjukhus	Stockholm, 182 88, Sweden
Completed	Avdelningen för kliniska prövningar AKP	Örebro, 703 62, Sweden
Completed	Södersjukhuset AB	Stockholm, 118 83, Sweden
Completed	Skellefteå Lasarett	Skellefteå, 931 86, Sweden
Completed	Falu Lasarett	Falun, 791 82, Sweden
Completed	Östersunds Sjukhus	Östersund, 831 83, Sweden
Completed	Koto Hospital	Koto-ku, 136-0072, Japan
Completed	Kishiwada Tokushukai Hospital	Kishiwada, 596-0042, Japan
Completed	Nishiarai Heart Central Clinic	Adachi-ku, 123-0845, Japan
Completed	Nakamura Cardiovascular Clinic	Itoshima, 819-1104, Japan
Completed	Hyogo Prefectural Harima-Himeji General Medical Center	Himeji, 670-8560, Japan
Completed	Tokyo Angel Hospital	Hachioji, 193-0811, Japan
Completed	Hayama Heart Center	Miura-gun, 240-0116, Japan
Completed	Yao Tokushukai General Hospital	Yao, 581-0011, Japan
Completed	Minamino Cardiovascular Hospital	Hachioji, 192-0918, Japan
Completed	Academisch Medisch Centrum (AMC)	AMSTERDAM, 1105 AZ, Netherlands
Completed	Maastricht UMC	MAASTRICHT, 6229 HX, Netherlands
Completed	Amphia Ziekenhuis, locatie Molengracht	BREDA, 4818 CK, Netherlands
Completed	Martini Ziekenhuis, Locatie van Swieten	GRONINGEN, 9728 NT, Netherlands
Completed	Ziekenhuis Rijnstate	ARNHEM, 6815 AD, Netherlands
Completed	Spaarne Gasthuis - locatie Zuid	HAARLEM, 2035 RC, Netherlands
Completed	Albert Schweitzer Ziekenhuis, Dordwijk	DORDRECHT, 3318 AT, Netherlands
Completed	Medisch Spectrum Twente	ENSCHEDE, 7511 JX, Netherlands
Completed	St Richard's Hospital	Chichester, PO19 6SE, United Kingdom
Completed	Tagore Medical Center	Balatonfured, 8230, Hungary

Primary Outcome

Number of participants with composite of International Society on Thrombosis and Hemostasis (ISTH) major bleeding or clinically relevant non-major (CRNM) bleeding
ISTH Major Bleeding criteria: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome), and/or 3. Clinically overt bleeding associated with a recent decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared to the most recent hemoglobin value available before the event, and/or 4. Clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. ISTH Clinically Relevant Non-Major Bleeding is considered any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria 1. requiring medical intervention by a healthcare professional. 2. leading to hospitalization or increased level of care. 3. prompting a face to face (i.e. not just a telephone or electronic communication) evaluation.
Time Frame:
After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)

Secondary Outcome

Number of participants with all bleeding
Adjudication of all bleeding events was performed by members of the Clinical events committee (CEC) who reviewed events in a blinded fashion and adjudicated and classified the following events in a consistent and unbiased manner according to the following classifications: ISTH (major, clinically relevant non-major and minor); Thrombolysis in myocardial infarction (TIMI major, minor, requiring medical attention, minimal); Bleeding Academic Research Consortium (BARC type 1, 2, 3, 5).
Time Frame:
After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)
Number of participants with ISTH major bleeding
ISTH Major Bleeding criteria: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome), and/or 3. Clinically overt bleeding associated with a recent decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared to the most recent hemoglobin value available before the event, and/or 4. Clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood.
Time Frame:
After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)
Number of participants of ISTH clinically relevant non-major (CRNM) bleeding
ISTH Clinically Relevant Non-Major Bleeding is considered any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria 1. requiring medical intervention by a healthcare professional. 2. leading to hospitalization or increased level of care. 3. prompting a face to face (i.e. not just a telephone or electronic communication) evaluation.
Time Frame:
After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)
Number of participants with ISTH minor bleeding
All other overt bleeding episodes not meeting ISTH Major Bleeding criteria or clinically relevant non major bleeding were classified as minor bleeding.
Time Frame:
After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)

Trial design

Multicenter, randomized, active comparator-controlled, double-blind, double-dummy, parallel group, dose-finding Phase 2 study to compare the safety of the oral FXIa inhibitor BAY2433334 to apixaban in patients with atrial fibrillation

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

N/A

Assignment

Parallel Assignment

Trial Arms

Additional Information

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