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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations Krajska nemocnice T. Bati, a.s. Zlin, Czech Republic, 762 75 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnice Slany Slany, Czech Republic, 274 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inselspital Universitätsspital Bern Bern, Switzerland, 3010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kantonsspital St. Gallen St. Gallen, Switzerland, 9007 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kantonsspital Aarau Aarau, Switzerland, 5001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ospedale regionale di Lugano Lugano, Switzerland, 6900 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Cantonal Universitaire de Genève Genève, Switzerland, 1211 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jessa Ziekenhuis HASSELT, Belgium, 3500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ St-Jan Brugge Oostende AV BRUGGE, Belgium, 8000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Imeldaziekenhuis - St-Elisabethkliniek BONHEIDEN, Belgium, 2820 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Antwerpen EDEGEM, Belgium, 2650 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations VZW Emmaus MECHELEN, Belgium, 2800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitària i Universitària de Bellvitge L'Hospitalet de Llobregat, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Virgen de la Victoria Málaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de la Santa Creu i de Sant Pau | Cardiología Barcelona, Spain, 08041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Delta ROESELARE, Belgium, 8800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Heart and Chest Hospital Liverpool, United Kingdom, L14 3PE | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Staploe Medical Centre Ely, United Kingdom, CB7 5SQ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Queen Elizabeth II Hospital Welwyn Garden City, United Kingdom, AL7 4HQ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northwick Park Hospital Harrow, United Kingdom, HA1 3UJ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Magyar Honvedseg Egeszsegugyi Kozpont Budapest, Hungary | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tolna Megyei Balassa Janos Korhaz Szekszard, Hungary, 7100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz Szentes, Hungary, 6600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kanizsai Dorottya Hospital Nagykanizsa, Hungary, 8800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Semmelweis/ Semmelweis Egyetem Budapest, Hungary, 1122 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pecsi Tudomanyegyetem Klinikai Kozpont Pecs, Hungary, 7624 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft. Nyiregyhaza, Hungary, 4400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinique Sante Cardio MC Montreal, Canada, H1T 3Y7 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut universitaire de cardiologie et de pneumologie Ste-Foy, Canada, G1V 4G5 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Kralovske Vinohrady Praha 10, Czech Republic, 100 34 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Klinicke a Experimentalni Mediciny Praha 4, Czech Republic, 140 21 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Plzen - Lochotin Plzen, Czech Republic, 304 60 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice v Motole Praha 5, Czech Republic, 150 06 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liepaja Regional Hospital Liepaja, Latvia, LV-3414 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations 1st Riga Clinical Hospital Riga, Latvia, LV-1001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations P. Stradins Clinical University Hospital Riga, Latvia, LV-1002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Daugavpils Regional Hospital Daugavpils, Latvia, LV-5417 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Riga East Clinical University Hospital "Gailezers" Riga, Latvia, LV-1038 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Doctor's Practice in Cardiology Daugavpils, Latvia, LV-5401 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL Toscana Sud-Est Arezzo, Italy, 52100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL Toscana Sud-Est Arezzo, Italy, 52044 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. di Perugia Perugia, Italy, 06129 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASUR Marche - Area Vasta 5 Ascoli Piceno, Italy, 63074 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Ospedale Policlinico San Martino Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Spedali Civili di Brescia Brescia, Italy, 25123 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Policlinico Umberto I Roma, Italy, 00161 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krankenhaus St. Josef Braunau Braunau, Austria, 5280 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinik Floridsdorf - Krankenhaus Nord Wien, Austria, 1210 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Landeskrankenhaus Feldkirch Feldkirch, Austria, 6807 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniklinikum Salzburg - Landeskrankenhaus Salzburg, Austria, 5020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Innsbruck Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ordensklinikum Linz GmbH Elisabethinen Linz, Austria, 4020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Henri Mondor CRETEIL, France, 94010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Régional - Saint Brieuc SAINT BRIEUC, France, 22000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Départemental Vendée LA ROCHE SUR YON CEDEX, France, 85025 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Louis Pasteur LE COUDRAY, France, 28630 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Bichat - Paris PARIS, France, 75018 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier - Valenciennes Cedex VALENCIENNES CEDEX, France, 59322 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital de Rangueil - Toulouse TOULOUSE, France, 31403 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Queen Elizabeth II Health Sciences Centre Halifax, Canada, B3H 3A7 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Montreal Heart Institute Montreal, Canada, H1T 1C8 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clemenstorget Hjärtmottagning Lund, Sweden, 222 21 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Danderyds sjukhus Stockholm, Sweden, 182 88 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Avdelningen för kliniska prövningar AKP Örebro, Sweden, 703 62 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Södersjukhuset AB Stockholm, Sweden, 118 83 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Skellefteå Lasarett Skellefteå, Sweden, 931 86 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Falu Lasarett Falun, Sweden, 791 82 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Östersunds Sjukhus Östersund, Sweden, 831 83 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Koto Hospital Koto-ku, Japan, 136-0072 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kishiwada Tokushukai Hospital Kishiwada, Japan, 596-0042 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nishiarai Heart Central Clinic Adachi-ku, Japan, 123-0845 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nakamura Cardiovascular Clinic Itoshima, Japan, 819-1104 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hyogo Prefectural Harima-Himeji General Medical Center Himeji, Japan, 670-8560 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokyo Angel Hospital Hachioji, Japan, 193-0811 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hayama Heart Center Miura-gun, Japan, 240-0116 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yao Tokushukai General Hospital Yao, Japan, 581-0011 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Minamino Cardiovascular Hospital Hachioji, Japan, 192-0918 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Academisch Medisch Centrum (AMC) AMSTERDAM, Netherlands, 1105 AZ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Maastricht UMC MAASTRICHT, Netherlands, 6229 HX | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Amphia Ziekenhuis, locatie Molengracht BREDA, Netherlands, 4818 CK | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Martini Ziekenhuis, Locatie van Swieten GRONINGEN, Netherlands, 9728 NT | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ziekenhuis Rijnstate ARNHEM, Netherlands, 6815 AD | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spaarne Gasthuis - locatie Zuid HAARLEM, Netherlands, 2035 RC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Albert Schweitzer Ziekenhuis, Dordwijk DORDRECHT, Netherlands, 3318 AT | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medisch Spectrum Twente ENSCHEDE, Netherlands, 7511 JX | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St Richard's Hospital Chichester, United Kingdom, PO19 6SE | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tagore Medical Center Balatonfured, Hungary, 8230 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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:
3
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.Timeframe: 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).Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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)
Additional Information
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