Clareo Health | A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke
A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
18 years of age or older
The patient willing and able to understand the Patient information Sheet and provide written informed consent
Atrial fibrillation with an indication for indefinite treatment with an oral anticoagulant
CHA2DS2-VASc score ≥ 3 if male or ≥ 4 if female, OR CHA2DS2-VASc score of 2 if male or 3 if female and at least one of the following enrichment criteria:
* 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.
You may not be if
Mechanical heart valve prosthesis
Moderate-to-severe mitral stenosis at the time of study inclusion.
Atrial fibrillation only due to reversible cause.
Participants after successful ablation therapy without documented recurrent AF or participants after left atrial appendage occlusion / exclusion or plan for ablation or Left atrial appendage (LAA) occlusion / exclusion within the next 6 months.
Recent ischemic stroke (within 7 days prior to randomization).
Active non-trivial bleeding; known chronic bleeding disorder ; history of non-traumatic intracranial hemorrhage.
Known significant liver disease or known hepatic insufficiency classified as Child-Pugh B or C at randomization.
Estimated glomerular filtration rate (eGFR) \< 25 mL/min/1.73 m2 within 14 days prior to randomization or on dialysis or expected to be started on dialysis within the next 12 months starting from randomization.
Major surgery during the last 30 days prior to randomization.
Known allergy, intolerance or hypersensitivity to either of the study interventions.
Any contraindication for the use of an anticoagulant or listed in the local labelling for apixaban.
Requirement for chronic anticoagulation for a different indication than AF, e.g. mechanical heart valve or left ventricular cardiac thrombus (atrial thrombus is allowed), or dual antiplatelet therapy (single agent therapy is allowed).
Treatment with Vitamin K antagonist (VKA) in the 10 days prior to randomization.
Concomitant use of or anticipated need for:
* daily or near daily (\> 5 days per week) therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) for more than 4 weeks during the study
* herbal or traditional medicine, and / or supplements with known anticoagulant and / or antiplatelet effect
* combined P-gp and strong / moderate CYP3A4 inducers Respective substances (apart from NSAIDs) must be stopped - in case of combined inhibitors / inducers of CYP3A4 and P-gp for at least 14 days before randomization.
Previous (within 30 days or 5 half-lives of the investigational drug, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s) or device(s). Registries and observational studies are allowed.
Known current alcohol and / or illicit drug abuse.
Close affiliation with the investigational site.
Any other history, condition or therapy, or uncontrolled intercurrent illness which would make the participant unsuitable for the study vulnerable or life expectancy \< 12 months.
