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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04218266
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation (AF) Drug: BAY2433334 Drug: Apixaban Other: BAY2433334 matching placebo Other: Apixaban matching placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 30, 2020
Estimated Primary Completion Date : August 20, 2021
Estimated Study Completion Date : August 20, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Arm Intervention/treatment
Experimental: BAY2433334 50mg+Apixaban matching placebo Drug: BAY2433334
Tablet, taken orally once a day.

Other: Apixaban matching placebo
Capsule, taken orally twice a day.

Experimental: BAY2433334 20mg+Apixaban matching placebo Drug: BAY2433334
Tablet, taken orally once a day.

Other: Apixaban matching placebo
Capsule, taken orally twice a day.

Active Comparator: 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.
Drug: Apixaban
Capsule, taken orally twice a day.

Other: BAY2433334 matching placebo
Tablet, taken orally once a day.




Primary Outcome Measures :
  1. Number of participants with composite of ISTH major and clinically relevant non-major bleeding [ Time Frame: From baseline to end of treatment (12 weeks) ]
    ISTH: International Society on Thrombosis and Hemostasis


Secondary Outcome Measures :
  1. Number of participants with all bleeding [ Time Frame: From baseline to end of treatment (12 weeks) ]
  2. Number of participants with ISTH major bleeding [ Time Frame: From baseline to end of treatment (12 weeks) ]
  3. Number of participants with ISTH clinically relevant non-major bleeding [ Time Frame: From baseline to end of treatment (12 weeks) ]
  4. Number of participants with ISTH minor bleeding [ Time Frame: From baseline to end of treatment (12 weeks) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04218266


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04218266    
Other Study ID Numbers: 19765
2019-002365-35 ( EudraCT Number )
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Availability of this study's data will 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.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants