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.
NCT ID: NCT04218266
Last Updated: 2022-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
755 participants
INTERVENTIONAL
2020-01-30
2021-10-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BAY2433334 50mg+Apixaban matching placebo
BAY2433334
Tablet, taken orally once a day.
Apixaban matching placebo
Capsule, taken orally twice a day.
BAY2433334 20mg+Apixaban matching placebo
BAY2433334
Tablet, taken orally once a day.
Apixaban matching placebo
Capsule, taken orally twice a day.
BAY2433334 matching placebo+Apixaban
Apixaban usual dose is 5 mg, reduced to 2.5 mg for participants with any 2 of the following criteria: age 80 years or older, body weight less than 60 kg, or serum creatinine level of 1.5 mg per dL or more.
Apixaban
Capsule, taken orally twice a day.
BAY2433334 matching placebo
Tablet, taken orally once a day.
Interventions
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BAY2433334
Tablet, taken orally once a day.
Apixaban
Capsule, taken orally twice a day.
BAY2433334 matching placebo
Tablet, taken orally once a day.
Apixaban matching placebo
Capsule, taken orally twice a day.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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A.O.U. Policlinico Umberto I
Rome, Lazio, Italy
Medizinische Universität Graz
Graz, Styria, Austria
Medizinische Universität Innsbruck
Innsbruck, Tyrol, Austria
Krankenhaus St. Josef Braunau
Braunau am Inn, Upper Austria, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, Austria
Landeskrankenhaus Feldkirch
Feldkirch, Vorarlberg, Austria
Uniklinikum Salzburg - Landeskrankenhaus
Salzburg, , Austria
Universitätsklinikum AKH Wien
Vienna, , Austria
Klinik Floridsdorf - Krankenhaus Nord
Vienna, , Austria
UZ Leuven Gasthuisberg
Leuven, Vlaams Brabant, Belgium
Imeldaziekenhuis - St-Elisabethkliniek
Bonheiden, , Belgium
AZ St-Jan Brugge Oostende AV
Bruges, , Belgium
UZ Antwerpen
Edegem, , Belgium
Jessa Ziekenhuis
Hasselt, , Belgium
VZW Emmaus
Mechelen, , Belgium
AZ Delta
Roeselare, , Belgium
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Clinique Sante Cardio MC
Montreal, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie
Ste-Foy, Quebec, Canada
Fakultni nemocnice Plzen - Lochotin
Pilsen, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Institut Klinicke a Experimentalni Mediciny
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Nemocnice Slany
Slaný, , Czechia
Krajska nemocnice T. Bati, a.s.
Zlín, , Czechia
Hôpital Henri Mondor
Créteil, , France
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, , 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, , France
Tagore Medical Center
Balatonfüred, , Hungary
University of Semmelweis/ Semmelweis Egyetem
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Kanizsai Dorottya Hospital
Nagykanizsa, , Hungary
Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.
Nyíregyháza, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, , Hungary
Tolna Megyei Balassa Janos Korhaz
Szekszárd, , Hungary
Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz
Szentes, , Hungary
IRCCS Ospedale Policlinico San Martino
Genoa, Liguria, Italy
ASST Spedali Civili di Brescia
Brescia, Lombardy, Italy
ASUR Marche - Area Vasta 5
Ascoli Piceno, The Marches, Italy
AUSL Toscana Sud-Est
Arezzo, Tuscany, Italy
AUSL Toscana Sud-Est
Arezzo, Tuscany, Italy
A.O. di Perugia
Perugia, Umbria, Italy
Nakamura Cardiovascular Clinic
Itoshima, Fukuoka, Japan
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji, Hyōgo, Japan
Hayama Heart Center
Miura-gun, Kanagawa, Japan
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan
Yao Tokushukai General Hospital
Yao, Osaka, Japan
Nishiarai Heart Central Clinic
Adachi-ku, Tokyo, Japan
Minamino Cardiovascular Hospital
Hachiōji, Tokyo, Japan
Tokyo Angel Hospital
Hachiōji, Tokyo, Japan
Koto Hospital
Koto-ku, Tokyo, Japan
Doctor's Practice in Cardiology
Daugavpils, , Latvia
Daugavpils Regional Hospital
Daugavpils, , Latvia
Liepaja Regional Hospital
Liepāja, , Latvia
1st Riga Clinical Hospital
Riga, , Latvia
P. Stradins Clinical University Hospital
Riga, , Latvia
Riga East Clinical University Hospital "Gailezers"
Riga, , Latvia
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, , Netherlands
Ciutat Sanitària i Universitària de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Ciutat Sanitària i Universitaria de la Vall d'Hebron
Barcelona, , Spain
Hospital de la Santa Creu i de Sant Pau | Cardiología
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Falu Lasarett
Falun, , Sweden
Clemenstorget Hjärtmottagning
Lund, , Sweden
Avdelningen för kliniska prövningar AKP
Örebro, , Sweden
Östersunds Sjukhus
Östersund, , Sweden
Skellefteå Lasarett
Skellefteå, , Sweden
Södersjukhuset AB
Stockholm, , Sweden
Danderyds sjukhus
Stockholm, , Sweden
Kantonsspital Aarau
Aarau, Canton of Aargau, Switzerland
Universitätsspital Basel
Basel, Canton of Basel-City, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Inselspital Universitätsspital Bern
Bern, , Switzerland
Hôpital Cantonal Universitaire de Genève
Geneva, , Switzerland
Ospedale regionale di Lugano
Lugano, , Switzerland
Staploe Medical Centre
Ely, Cambridgeshire, United Kingdom
Queen Elizabeth II Hospital
Welwyn Garden City, Hertfordshire, United Kingdom
Northwick Park Hospital
Harrow, London, United Kingdom
St Richard's Hospital
Chichester, West Sussex, United Kingdom
Heart and Chest Hospital
Liverpool, , United Kingdom
Countries
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References
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Piccini JP, Caso V, Connolly SJ, Fox KAA, Oldgren J, Jones WS, Gorog DA, Durdil V, Viethen T, Neumann C, Mundl H, Patel MR; PACIFIC-AF Investigators. Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study. Lancet. 2022 Apr 9;399(10333):1383-1390. doi: 10.1016/S0140-6736(22)00456-1. Epub 2022 Apr 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
Other Identifiers
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2019-002365-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
19765
Identifier Type: -
Identifier Source: org_study_id
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