Trial Condition(s):
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)
19765
Not Available
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.
- 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
- 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
Locations | Status | |
---|---|---|
Locations Krajska nemocnice T. Bati, a.s. Zlin, Czech Republic, 762 75 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnice Slany Slany, Czech Republic, 274 01 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inselspital Universitätsspital Bern Bern, Switzerland, 3010 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kantonsspital Winterthur Winterthur, Switzerland, 8401 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kantonsspital St. Gallen St. Gallen, Switzerland, 9007 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kantonsspital Aarau Aarau, Switzerland, 5001 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Luzerner Kantonsspital Luzern, Switzerland, 6000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ospedale regionale di Lugano Lugano, Switzerland, 6900 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Cantonal Universitaire de Genève Genève, Switzerland, 1211 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jessa Ziekenhuis HASSELT, Belgium, 3500 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ St-Jan Brugge Oostende AV BRUGGE, Belgium, 8000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Imeldaziekenhuis - St-Elisabethkliniek BONHEIDEN, Belgium, 2820 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Antwerpen EDEGEM, Belgium, 2650 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations VZW Emmaus MECHELEN, Belgium, 2800 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Arnau de Vilanova de Valencia Valencia, Spain, 46015 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitària i Universitària de Bellvitge L'Hospitalet de Llobregat, Spain, 08907 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Virgen de la Victoria Málaga, Spain, 29010 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital del Mar Barcelona, Spain, 08003 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Ramón y Cajal Madrid, Spain, 28034 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de la Santa Creu i de Sant Pau Barcelona, Spain, 08041 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Delta ROESELARE, Belgium, 8800 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Heart and Chest Hospital Liverpool, United Kingdom, L14 3PE | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Staploe Medical Centre Ely, United Kingdom, CB7 5SQ | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Queen Elizabeth II Hospital Welwyn Garden City, United Kingdom, AL7 4HQ | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chesterfield Royal Hospital Chesterfield, United Kingdom, S44 5DX | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northwick Park Hospital Harrow, United Kingdom, HA1 3UJ | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Hospital of Wales Cardiff, United Kingdom, CF14 4XW | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz Budapest, Hungary | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tolna Megyei Balassa Janos Korhaz Szekszard, Hungary, 7100 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dr. Bugyi Istvan Hopsital (Korhaz) Szentes, Hungary, 6600 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kanizsai Dorottya Hospital Nagykanizsa, Hungary, 8800 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Semmelweis/ Semmelweis Egyetem Budapest, Hungary, 1122 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pecsi Tudomanyegyetem Klinikai Kozpont Pecs, Hungary, 7624 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz Budapest, Hungary, 1134 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft. Nyiregyhaza, Hungary, 4400 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Population Health Research Institute Hamilton, Canada, L8L 0A6 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinique Sante Cardio MC Montreal, Canada, H1T 3Y7 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Alexandra Hospital Edmonton, Canada, T5H 3V9 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Michael's Hospital Health Centre Toronto, Canada, M5B 1W8 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cambridge Cardiac Care Center Cambridge, Canada, N1R 6V6 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut universitaire de cardiologie et de pneumologie Ste-Foy, Canada, G1V 4G5 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Kralovske Vinohrady Praha 10, Czech Republic, 100 34 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Klinicke a Experimentalni Mediciny Praha 4, Czech Republic, 140 21 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oblastni Nemocnice Kladno Kladno, Czech Republic, 27259 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Plzen Plzen, Czech Republic, 304 60 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnice Pardubickeho kraje a.s., Orlickoustecka nemocnice Usti nad Orlici, Czech Republic, 56218 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice v Motole Praha 5, Czech Republic, 150 06 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ventspils Hospital Ventspils, Latvia, LV-3601 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liepaja Regional Hospital Liepaja, Latvia, LV-3414 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations 1st Riga Clinical Hospital Riga, Latvia, LV-1001 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinic of Obstetrics and Gynaecology Riga, Latvia, LV-1002 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Daugavpils Regional Hospital Daugavpils, Latvia, LV-5417 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Riga East Clinical University Hospital "Gailezers" Riga, Latvia, LV-1038 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Doctor's Practice in Cardiology Daugavpils, Latvia, LV-5401 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL Toscana Sud-Est Arezzo, Italy, 52100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL Toscana Sud-Est Arezzo, Italy, 52040 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. di Perugia Perugia, Italy, 06132 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASUR Marche - Area Vasta 5 Ascoli Piceno, Italy, 63074 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro Genova, Italy, 16132 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Spedali Civili Brescia, Italy, 25123 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. Ospedali Riuniti Villa Sofia-Cervello Palermo, Italy, 90146 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Policlinico Umberto I Roma, Italy, 00161 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krankenhaus St. Josef Braunau Braunau, Austria, 5280 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krankenhauses Nord – Klinik Floridsdorf Wien, Austria, 1210 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Landeskrankenhaus Feldkirch Feldkirch, Austria, 6807 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniklinikum Salzburg - Landeskrankenhaus Salzburg, Austria, 5020 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Allgemeines Krankenhaus der Stadt Wien Wien, Austria, 1090 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Innsbruck Innsbruck, Austria, 6020 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ordensklinikum Linz GmbH Elisabethinen Linz, Austria, 4020 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Henri Mondor CRETEIL, France, 94010 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Régional - Saint Brieuc SAINT BRIEUC, France, 22000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Départemental Vendée LA ROCHE SUR YON CEDEX, France, 85025 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Louis Pasteur LE COUDRAY, France, 28630 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Bichat - Paris PARIS, France, 75018 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier - Valenciennes Cedex VALENCIENNES CEDEX, France, 59322 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital de Rangueil - Toulouse TOULOUSE, France, 31403 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital de Cardiologie - Lille LILLE cedex, France, 59037 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Queen Elizabeth II Health Sciences Centre Halifax, Canada, B3H 3A7 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Montreal Heart Institute Montreal, Canada, H1T 1C8 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations H. Hartziekenhuis Mol MOL, Belgium, 2400 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SU/Östra Göteborg, Sweden, 416 85 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Capio Citykliniken Närsjukvården AB Lund, Sweden, 222 21 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Danderyds sjukhus Stockholm, Sweden, 182 88 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Avdelningen för kliniska prövningar AKP Örebro, Sweden, 703 62 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Södersjukhuset AB Stockholm, Sweden, 118 83 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Skellefteå Lasarett Skellefteå, Sweden, 931 86 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Falu Lasarett Falun, Sweden, 791 82 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Östersunds Sjukhus Östersund, Sweden, 831 83 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Koto Hospital Koto-ku, Japan, 136-0072 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kishiwada Tokushukai Hospital Kishiwada, Japan, 596-0042 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nishiarai Heart Center Hospital Adachi-ku, Japan, 123-0845 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nakamura Cardiovascular Clinic Itoshima, Japan, 819-1104 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hyogo Brain and Heart Center Himeji, Japan, 670-0981 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokyo Angel Hospital Hachioji, Japan, 193-0811 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Okinawa Tokushukai Hayama Heart Center Miura-gun, Japan, 240-0116 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yao Tokushukai General Hospital Yao, Japan, 581-0011 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Minamino Cardiovascular Hospital Hachioji, Japan, 192-0918 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Academisch Medisch Centrum (AMC) AMSTERDAM, Netherlands, 1105 AZ | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Maastricht UMC MAASTRICHT, Netherlands, 6229 HX | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Amphia Ziekenhuis, locatie Molengracht BREDA, Netherlands, 4818 CK | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Martini Ziekenhuis, Locatie van Swieten GRONINGEN, Netherlands, 9728 NT | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ziekenhuis Rijnstate ARNHEM, Netherlands, 6815 AD | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spaarne Gasthuis - locatie Zuid HAARLEM, Netherlands, 2035 RC | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Albert Schweitzer Ziekenhuis, Locatie Dordwijk DORDRECHT, Netherlands, 3318 AT | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medisch Spectrum Twente ENSCHEDE, Netherlands, 7511 JX | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St Richard's Hospital Chichester, United Kingdom, PO19 6SE | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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:
3
Not Available