Phase 2
Completed N=755
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.
Atrial Fibrillation (AF)
Source: ClinicalTrials.gov NCT04218266 ↗
Enrolled (actual)
755
Serious AEs
8.2%
Results posted
Oct 2022
Primary outcomePrimary: Number of Participants With Composite of International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding or Clinically Relevant Non-major (CRNM) Bleeding — 3; 1; 4; 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Composite of International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding or Clinically Relevant Non-major (CRNM) Bleeding |
3; 1; 4; 6 | — |
| SECONDARY Number of Participants With All Bleeding |
12; 10; 22; 26 | — |
| SECONDARY Number of Participants With ISTH Major Bleeding |
0; 0; 0 | — |
| SECONDARY Number of Participants of ISTH Clinically Relevant Non-major (CRNM) Bleeding |
3; 1; 4; 6 | — |
| SECONDARY Number of Participants With ISTH Minor Bleeding |
10; 9; 19; 20 | — |
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
Data sourced from ClinicalTrials.gov (NCT04218266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.