A multicenter, international, randomized, active comparator-controlled, double-blind, doubledummy,parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oralFXIa inhibitor asundexian (BAY 2433334) with apixaban for the prevention of stroke orsystemic embolism in male and female participants aged 18 years and older with atrialfibrillation at risk for stroke
R
Rolf Kreutz, MD
Primary Investigator
Not Recruiting
18 years - 100 years
All
Phase
3
10 participants needed
1 Location
Brief description of study
To demonstrate that asundexian is superior (at
least non-inferior) when compared with
apixaban for prevention of stroke and systemic embolism in participants with atrial fibrillation at risk for stroke
apixaban for prevention of stroke and systemic embolism in participants with atrial fibrillation at risk for stroke
To demonstrate that asundexian is superior to
apixaban as assessed by ISTH major bleeding
in participants with atrial fibrillation at risk for
stroke
To demonstrate that asundexian is superior to
apixaban with respect to benefit and risk
Detailed description of study
Participants will be randomized to 1 of the 2 arms
as follows:
1 investigational study intervention arm (asundexian) or
1 active comparator arm (apixaban)
as follows:
1 investigational study intervention arm (asundexian) or
1 active comparator arm (apixaban)
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: atrial fibulation
-
Age: 18 years - 100 years
-
Gender: All
Patients will be eligible for the study based on their CHA2DS2-VASc risk score, among other
criteria. With a score of ≥ 3 if male or ≥ 4 if female, patients can get enrolled straight into the
study. Patients with a CHA2DS2-VASc score of 2 if male or 3 if female can participate in the
study by meeting at least one of the following enrichment criteria in addition:
age ≥ 70
previous stroke, transient ischemic attack, or systemic embolism
renal dysfunction with eGFR < 50 ml/min within 14 days prior to randomization
prior episode of non-traumatic major bleeding
current single agent antiplatelet therapy planned to continue for at least 6 months after
randomization
≤ 6 consecutive weeks of treatment with oral anticoagulant prior to randomization
criteria. With a score of ≥ 3 if male or ≥ 4 if female, patients can get enrolled straight into the
study. Patients with a CHA2DS2-VASc score of 2 if male or 3 if female can participate in the
study by meeting at least one of the following enrichment criteria in addition:
age ≥ 70
previous stroke, transient ischemic attack, or systemic embolism
renal dysfunction with eGFR < 50 ml/min within 14 days prior to randomization
prior episode of non-traumatic major bleeding
current single agent antiplatelet therapy planned to continue for at least 6 months after
randomization
≤ 6 consecutive weeks of treatment with oral anticoagulant prior to randomization
Updated on
01 Aug 2024.
Study ID: ECRO-BAYER-OCEANIC-AF, 19876
