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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04218266
Other study ID # 19765
Secondary ID 2019-002365-35
Status Completed
Phase Phase 2
First received
Last updated
Start date January 30, 2020
Est. completion date October 8, 2021

Study information

Verified date October 2022
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 755
Est. completion date October 8, 2021
Est. primary completion date October 8, 2021
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BAY2433334
Tablet, taken orally once a day.
Apixaban
Capsule, taken orally twice a day.
Other:
BAY2433334 matching placebo
Tablet, taken orally once a day.
Apixaban matching placebo
Capsule, taken orally twice a day.

Locations

Country Name City State
Austria Krankenhaus St. Josef Braunau Braunau Oberösterreich
Austria Landeskrankenhaus Feldkirch Feldkirch Vorarlberg
Austria Medizinische Universität Graz Graz Steiermark
Austria Medizinische Universität Innsbruck Innsbruck Tirol
Austria Ordensklinikum Linz GmbH Elisabethinen Linz Oberösterreich
Austria Uniklinikum Salzburg - Landeskrankenhaus Salzburg
Austria Klinik Floridsdorf - Krankenhaus Nord Wien
Austria Universitätsklinikum AKH Wien Wien
Belgium Imeldaziekenhuis - St-Elisabethkliniek Bonheiden
Belgium AZ St-Jan Brugge Oostende AV Brugge
Belgium UZ Antwerpen Edegem
Belgium Jessa Ziekenhuis Hasselt
Belgium UZ Leuven Gasthuisberg Leuven Vlaams Brabant
Belgium VZW Emmaus Mechelen
Belgium AZ Delta Roeselare
Canada Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia
Canada Clinique Sante Cardio MC Montreal Quebec
Canada Montreal Heart Institute Montreal Quebec
Canada Institut universitaire de cardiologie et de pneumologie Ste-Foy Quebec
Czechia Fakultni nemocnice Plzen - Lochotin Plzen
Czechia Fakultni nemocnice Kralovske Vinohrady Praha 10
Czechia Institut Klinicke a Experimentalni Mediciny Praha 4
Czechia Fakultni nemocnice v Motole Praha 5
Czechia Nemocnice Slany Slany
Czechia Krajska nemocnice T. Bati, a.s. Zlin
France Hôpital Henri Mondor Creteil
France Centre Hospitalier Départemental Vendée La Roche Sur Yon Cedex
France Centre Hospitalier Louis Pasteur Le Coudray
France Hopital Bichat - Paris Paris
France Centre Hospitalier Régional - Saint Brieuc Saint Brieuc
France Hôpital de Rangueil - Toulouse Toulouse
France Centre Hospitalier - Valenciennes Cedex Valenciennes Cedex
Hungary Tagore Medical Center Balatonfured
Hungary Magyar Honvedseg Egeszsegugyi Kozpont Budapest
Hungary University of Semmelweis/ Semmelweis Egyetem Budapest
Hungary Kanizsai Dorottya Hospital Nagykanizsa
Hungary Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft. Nyiregyhaza
Hungary Pecsi Tudomanyegyetem Klinikai Kozpont Pecs
Hungary Tolna Megyei Balassa Janos Korhaz Szekszard
Hungary Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz Szentes
Italy AUSL Toscana Sud-Est Arezzo Toscana
Italy AUSL Toscana Sud-Est Arezzo Toscana
Italy ASUR Marche - Area Vasta 5 Ascoli Piceno Marche
Italy ASST Spedali Civili di Brescia Brescia Lombardia
Italy IRCCS Ospedale Policlinico San Martino Genova Liguria
Italy A.O. di Perugia Perugia Umbria
Italy A.O.U. Policlinico Umberto I Roma Lazio
Japan Nishiarai Heart Central Clinic Adachi-ku Tokyo
Japan Minamino Cardiovascular Hospital Hachioji Tokyo
Japan Tokyo Angel Hospital Hachioji Tokyo
Japan Hyogo Prefectural Harima-Himeji General Medical Center Himeji Hyogo
Japan Nakamura Cardiovascular Clinic Itoshima Fukuoka
Japan Kishiwada Tokushukai Hospital Kishiwada Osaka
Japan Koto Hospital Koto-ku Tokyo
Japan Hayama Heart Center Miura-gun Kanagawa
Japan Yao Tokushukai General Hospital Yao Osaka
Latvia Daugavpils Regional Hospital Daugavpils
Latvia Doctor's Practice in Cardiology Daugavpils
Latvia Liepaja Regional Hospital Liepaja
Latvia 1st Riga Clinical Hospital Riga
Latvia P. Stradins Clinical University Hospital Riga
Latvia Riga East Clinical University Hospital "Gailezers" Riga
Netherlands Academisch Medisch Centrum (AMC) Amsterdam
Netherlands Ziekenhuis Rijnstate Arnhem
Netherlands Amphia Ziekenhuis, locatie Molengracht Breda
Netherlands Albert Schweitzer Ziekenhuis, Dordwijk Dordrecht
Netherlands Medisch Spectrum Twente Enschede
Netherlands Martini Ziekenhuis, Locatie van Swieten Groningen
Netherlands Spaarne Gasthuis - locatie Zuid Haarlem
Netherlands Maastricht UMC Maastricht
Spain Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona
Spain Hospital de la Santa Creu i de Sant Pau | Cardiología Barcelona
Spain Ciutat Sanitària i Universitària de Bellvitge L'Hospitalet de Llobregat Barcelona
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Virgen de la Victoria Málaga
Sweden Falu Lasarett Falun
Sweden Clemenstorget Hjärtmottagning Lund
Sweden Avdelningen för kliniska prövningar AKP Örebro
Sweden Östersunds Sjukhus Östersund
Sweden Skellefteå Lasarett Skellefteå
Sweden Danderyds sjukhus Stockholm
Sweden Södersjukhuset AB Stockholm
Switzerland Kantonsspital Aarau Aarau Aargau
Switzerland Universitätsspital Basel Basel Basel-Stadt
Switzerland Inselspital Universitätsspital Bern Bern
Switzerland Hôpital Cantonal Universitaire de Genève Genève
Switzerland Ospedale regionale di Lugano Lugano
Switzerland Kantonsspital St. Gallen St. Gallen Sankt Gallen
United Kingdom St Richard's Hospital Chichester West Sussex
United Kingdom Staploe Medical Centre Ely Cambridgeshire
United Kingdom Northwick Park Hospital Harrow London
United Kingdom Heart and Chest Hospital Liverpool
United Kingdom Queen Elizabeth II Hospital Welwyn Garden City Hertfordshire

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Czechia,  France,  Hungary,  Italy,  Japan,  Latvia,  Netherlands,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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 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). 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 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. 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 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. 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 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. 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)
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