Atrial Fibrillation (AF) Clinical Trial
— PACIFIC-AFOfficial title:
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
Verified date | October 2022 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Austria, Belgium, Canada, Czechia, France, Hungary, Italy, Japan, Latvia, Netherlands, Spain, Sweden, Switzerland, United Kingdom,
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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