Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT04684732
Eligibility Criteria:
Part I
Inclusion Criteria:
* Patients with nonvalvular atrial fibrillation
* Patients who is receiving a stable dose of apixaban for primary or secondary prevention of stroke, transient ischemic attack, and systemic embolism.
Exclusion Criteria:
* Pregnant or lactating
* End stage renal disease patients who required chronic renal replacement therapy to sustained life
* History of acute kidney injury within the previous 3 months
* Severe hepatic impairment (Child-Pugh class C)
* Any gastrointestinal disorder that could impact the absorption of study drug
* CYP3A4 Moderate/Strong Inhibitors: ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, naproxen, clarithromycin, rifampicin, phenytoin, carbamazepine, phenobarbital, diltiazem, and St.John's Wort
Part II
Inclusion Criteria:
* Patients with nonvalvular atrial fibrillation
* Patients who was prescribed apixaban for primary or secondary prevention of stroke, transient ischemic attack, and systemic embolism.
Exclusion Criteria:
* Pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04684732
Study Brief:
Protocol Section:
NCT04684732