check_circleStudy Completed
Atrial fibrillation (AF)
Bayer Identifier:
19765
ClinicalTrials.gov Identifier:
EudraCT Number:
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.
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
AllAge
45 - N/ATrial summary
Enrollment Goal
755Trial Dates
January 2020 - October 2021Phase
Phase 2Could I Receive a placebo
NoProducts
Asundexian (BAY2433334)Accepts Healthy Volunteer
NoWhere 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Withdrawn | Kantonsspital Winterthur | Winterthur, 8401, Switzerland |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Withdrawn | Luzerner Kantonsspital | Luzern, 6000, Switzerland |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) bleedingISTH 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.date_rangeTime 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 bleedingAdjudication 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).date_rangeTime 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 bleedingISTH 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.date_rangeTime 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) bleedingISTH 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.date_rangeTime 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 bleedingAll other overt bleeding episodes not meeting ISTH Major Bleeding criteria or clinically relevant non major bleeding were classified as minor bleeding.date_rangeTime 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
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
3