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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)

Primary Purpose

Atrial Fibrillation (AF)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BAY2433334
Apixaban
BAY2433334 matching placebo
Apixaban matching placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation (AF)

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Krankenhaus St. Josef Braunau
  • Ordensklinikum Linz GmbH Elisabethinen
  • Medizinische Universität Graz
  • Medizinische Universität Innsbruck
  • Landeskrankenhaus Feldkirch
  • Uniklinikum Salzburg - Landeskrankenhaus
  • Universitätsklinikum AKH Wien
  • Klinik Floridsdorf - Krankenhaus Nord
  • UZ Leuven Gasthuisberg
  • Imeldaziekenhuis - St-Elisabethkliniek
  • AZ St-Jan Brugge Oostende AV
  • UZ Antwerpen
  • Jessa Ziekenhuis
  • VZW Emmaus
  • AZ Delta
  • Queen Elizabeth II Health Sciences Centre
  • Montreal Heart Institute
  • Clinique Sante Cardio MC
  • Institut universitaire de cardiologie et de pneumologie
  • Fakultni nemocnice Plzen - Lochotin
  • Fakultni nemocnice Kralovske Vinohrady
  • Institut Klinicke a Experimentalni Mediciny
  • Fakultni nemocnice v Motole
  • Nemocnice Slany
  • Krajska nemocnice T. Bati, a.s.
  • Hôpital Henri Mondor
  • Centre Hospitalier Départemental Vendée
  • Centre Hospitalier Louis Pasteur
  • Hopital Bichat - Paris
  • Centre Hospitalier Régional - Saint Brieuc
  • Hôpital de Rangueil - Toulouse
  • Centre Hospitalier - Valenciennes Cedex
  • Tagore Medical Center
  • University of Semmelweis/ Semmelweis Egyetem
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • Kanizsai Dorottya Hospital
  • Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.
  • Pecsi Tudomanyegyetem Klinikai Kozpont
  • Tolna Megyei Balassa Janos Korhaz
  • Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz
  • A.O.U. Policlinico Umberto I
  • IRCCS Ospedale Policlinico San Martino
  • ASST Spedali Civili di Brescia
  • ASUR Marche - Area Vasta 5
  • AUSL Toscana Sud-Est
  • AUSL Toscana Sud-Est
  • A.O. di Perugia
  • Nakamura Cardiovascular Clinic
  • Hyogo Prefectural Harima-Himeji General Medical Center
  • Hayama Heart Center
  • Kishiwada Tokushukai Hospital
  • Yao Tokushukai General Hospital
  • Nishiarai Heart Central Clinic
  • Minamino Cardiovascular Hospital
  • Tokyo Angel Hospital
  • Koto Hospital
  • Doctor's Practice in Cardiology
  • Daugavpils Regional Hospital
  • Liepaja Regional Hospital
  • 1st Riga Clinical Hospital
  • P. Stradins Clinical University Hospital
  • Riga East Clinical University Hospital "Gailezers"
  • Academisch Medisch Centrum (AMC)
  • Ziekenhuis Rijnstate
  • Amphia Ziekenhuis, locatie Molengracht
  • Albert Schweitzer Ziekenhuis, Dordwijk
  • Medisch Spectrum Twente
  • Martini Ziekenhuis, Locatie van Swieten
  • Spaarne Gasthuis - locatie Zuid
  • Maastricht UMC
  • Ciutat Sanitària i Universitària de Bellvitge
  • Ciutat Sanitària i Universitaria de la Vall d'Hebron
  • Hospital de la Santa Creu i de Sant Pau | Cardiología
  • Hospital Universitario 12 de Octubre
  • Hospital Virgen de la Victoria
  • Falu Lasarett
  • Clemenstorget Hjärtmottagning
  • Skellefteå Lasarett
  • Södersjukhuset AB
  • Danderyds sjukhus
  • Avdelningen för kliniska prövningar AKP
  • Östersunds Sjukhus
  • Kantonsspital Aarau
  • Universitätsspital Basel
  • Kantonsspital St. Gallen
  • Inselspital Universitätsspital Bern
  • Hôpital Cantonal Universitaire de Genève
  • Ospedale regionale di Lugano
  • Staploe Medical Centre
  • Queen Elizabeth II Hospital
  • Northwick Park Hospital
  • St Richard's Hospital
  • Heart and Chest Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

BAY2433334 50mg+Apixaban matching placebo

BAY2433334 20mg+Apixaban matching placebo

BAY2433334 matching placebo+Apixaban

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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.

Full Information

First Posted
January 2, 2020
Last Updated
October 26, 2022
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT04218266
Brief Title
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.
Acronym
PACIFIC-AF
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
October 8, 2021 (Actual)
Study Completion Date
October 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation (AF)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
755 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAY2433334 50mg+Apixaban matching placebo
Arm Type
Experimental
Arm Title
BAY2433334 20mg+Apixaban matching placebo
Arm Type
Experimental
Arm Title
BAY2433334 matching placebo+Apixaban
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BAY2433334
Intervention Description
Tablet, taken orally once a day.
Intervention Type
Drug
Intervention Name(s)
Apixaban
Intervention Description
Capsule, taken orally twice a day.
Intervention Type
Other
Intervention Name(s)
BAY2433334 matching placebo
Intervention Description
Tablet, taken orally once a day.
Intervention Type
Other
Intervention Name(s)
Apixaban matching placebo
Intervention Description
Capsule, taken orally twice a day.
Primary Outcome Measure Information:
Title
Number of Participants With Composite of International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding or Clinically Relevant Non-major (CRNM) Bleeding
Description
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.
Time Frame
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 Measure Information:
Title
Number of Participants With All Bleeding
Description
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).
Time Frame
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)
Title
Number of Participants With ISTH Major Bleeding
Description
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.
Time Frame
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)
Title
Number of Participants of ISTH Clinically Relevant Non-major (CRNM) Bleeding
Description
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.
Time Frame
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)
Title
Number of Participants With ISTH Minor Bleeding
Description
All other overt bleeding episodes not meeting ISTH Major Bleeding criteria or clinically relevant non major bleeding were classified as minor bleeding.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Krankenhaus St. Josef Braunau
City
Braunau
State/Province
Oberösterreich
ZIP/Postal Code
5280
Country
Austria
Facility Name
Ordensklinikum Linz GmbH Elisabethinen
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universität Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Landeskrankenhaus Feldkirch
City
Feldkirch
State/Province
Vorarlberg
ZIP/Postal Code
6807
Country
Austria
Facility Name
Uniklinikum Salzburg - Landeskrankenhaus
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Universitätsklinikum AKH Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Klinik Floridsdorf - Krankenhaus Nord
City
Wien
ZIP/Postal Code
1210
Country
Austria
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Imeldaziekenhuis - St-Elisabethkliniek
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ St-Jan Brugge Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
VZW Emmaus
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Clinique Sante Cardio MC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 3Y7
Country
Canada
Facility Name
Institut universitaire de cardiologie et de pneumologie
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Fakultni nemocnice Plzen - Lochotin
City
Plzen
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Institut Klinicke a Experimentalni Mediciny
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Nemocnice Slany
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
Krajska nemocnice T. Bati, a.s.
City
Zlin
ZIP/Postal Code
762 75
Country
Czechia
Facility Name
Hôpital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Hospitalier Départemental Vendée
City
La Roche Sur Yon Cedex
ZIP/Postal Code
85025
Country
France
Facility Name
Centre Hospitalier Louis Pasteur
City
Le Coudray
ZIP/Postal Code
28630
Country
France
Facility Name
Hopital Bichat - Paris
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Centre Hospitalier Régional - Saint Brieuc
City
Saint Brieuc
ZIP/Postal Code
22000
Country
France
Facility Name
Hôpital de Rangueil - Toulouse
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
Centre Hospitalier - Valenciennes Cedex
City
Valenciennes Cedex
ZIP/Postal Code
59322
Country
France
Facility Name
Tagore Medical Center
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
University of Semmelweis/ Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
Country
Hungary
Facility Name
Kanizsai Dorottya Hospital
City
Nagykanizsa
ZIP/Postal Code
8800
Country
Hungary
Facility Name
Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Tolna Megyei Balassa Janos Korhaz
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
A.O.U. Policlinico Umberto I
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
IRCCS Ospedale Policlinico San Martino
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
ASST Spedali Civili di Brescia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
ASUR Marche - Area Vasta 5
City
Ascoli Piceno
State/Province
Marche
ZIP/Postal Code
63074
Country
Italy
Facility Name
AUSL Toscana Sud-Est
City
Arezzo
State/Province
Toscana
ZIP/Postal Code
52044
Country
Italy
Facility Name
AUSL Toscana Sud-Est
City
Arezzo
State/Province
Toscana
ZIP/Postal Code
52100
Country
Italy
Facility Name
A.O. di Perugia
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06129
Country
Italy
Facility Name
Nakamura Cardiovascular Clinic
City
Itoshima
State/Province
Fukuoka
ZIP/Postal Code
819-1104
Country
Japan
Facility Name
Hyogo Prefectural Harima-Himeji General Medical Center
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-8560
Country
Japan
Facility Name
Hayama Heart Center
City
Miura-gun
State/Province
Kanagawa
ZIP/Postal Code
240-0116
Country
Japan
Facility Name
Kishiwada Tokushukai Hospital
City
Kishiwada
State/Province
Osaka
ZIP/Postal Code
596-0042
Country
Japan
Facility Name
Yao Tokushukai General Hospital
City
Yao
State/Province
Osaka
ZIP/Postal Code
581-0011
Country
Japan
Facility Name
Nishiarai Heart Central Clinic
City
Adachi-ku
State/Province
Tokyo
ZIP/Postal Code
123-0845
Country
Japan
Facility Name
Minamino Cardiovascular Hospital
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0918
Country
Japan
Facility Name
Tokyo Angel Hospital
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
193-0811
Country
Japan
Facility Name
Koto Hospital
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
136-0072
Country
Japan
Facility Name
Doctor's Practice in Cardiology
City
Daugavpils
ZIP/Postal Code
LV-5401
Country
Latvia
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Facility Name
Liepaja Regional Hospital
City
Liepaja
ZIP/Postal Code
LV-3414
Country
Latvia
Facility Name
1st Riga Clinical Hospital
City
Riga
ZIP/Postal Code
LV-1001
Country
Latvia
Facility Name
P. Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Riga East Clinical University Hospital "Gailezers"
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Facility Name
Academisch Medisch Centrum (AMC)
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Ziekenhuis Rijnstate
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Amphia Ziekenhuis, locatie Molengracht
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis, Dordwijk
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7511 JX
Country
Netherlands
Facility Name
Martini Ziekenhuis, Locatie van Swieten
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
Spaarne Gasthuis - locatie Zuid
City
Haarlem
ZIP/Postal Code
2035 RC
Country
Netherlands
Facility Name
Maastricht UMC
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Ciutat Sanitària i Universitària de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Ciutat Sanitària i Universitaria de la Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital de la Santa Creu i de Sant Pau | Cardiología
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Falu Lasarett
City
Falun
ZIP/Postal Code
791 82
Country
Sweden
Facility Name
Clemenstorget Hjärtmottagning
City
Lund
ZIP/Postal Code
222 21
Country
Sweden
Facility Name
Skellefteå Lasarett
City
Skellefteå
ZIP/Postal Code
931 86
Country
Sweden
Facility Name
Södersjukhuset AB
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Danderyds sjukhus
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Avdelningen för kliniska prövningar AKP
City
Örebro
ZIP/Postal Code
703 62
Country
Sweden
Facility Name
Östersunds Sjukhus
City
Östersund
ZIP/Postal Code
831 83
Country
Sweden
Facility Name
Kantonsspital Aarau
City
Aarau
State/Province
Aargau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Universitätsspital Basel
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Inselspital Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Hôpital Cantonal Universitaire de Genève
City
Genève
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Ospedale regionale di Lugano
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Staploe Medical Centre
City
Ely
State/Province
Cambridgeshire
ZIP/Postal Code
CB7 5SQ
Country
United Kingdom
Facility Name
Queen Elizabeth II Hospital
City
Welwyn Garden City
State/Province
Hertfordshire
ZIP/Postal Code
AL7 4HQ
Country
United Kingdom
Facility Name
Northwick Park Hospital
City
Harrow
State/Province
London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
St Richard's Hospital
City
Chichester
State/Province
West Sussex
ZIP/Postal Code
PO19 6SE
Country
United Kingdom
Facility Name
Heart and Chest Hospital
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Citations:
PubMed Identifier
35385695
Citation
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.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
URL
http://clinicaltrials.bayer.com/
Description
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.

Learn more about this trial

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.

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