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 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
NCT ID:
NCT02303795
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients aged \>18 years at time of inclusion
2. Patients with Persistent or paroxysmal Atrial Fibrillation or flutter with bioprosthetic mitral valves.
* The patient must be able to give informed consent
Exclusion Criteria:
1. Cardiovascular-related conditions as known presence of cardiac thrombus or tumor
* Active endocarditis
* Uncontrolled hypertension
2. Hemorrhage risk-related criteria
* Active internal bleeding
* History of, or condition associated with, increased bleeding risk
3. Concomitant conditions and therapies
* History of previous thromboembolism with high risk of bleeding:
* Severe, disabling stroke (modified Rankin score of 4-5, inclusive) within 3 months
* Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
* Acute MI within the last 14 days prior to randomization
* Treatment with: Chronic aspirin therapy \> 100 mg daily or dual antiplatelet therapy; Intravenous antiplatelets; Fibrinolytics; Anticipated need for long-term treatment with a nonsteroidal antiinflammatory drug; Systemic treatment with a strong inhibitor of cytochrome P450 3A4, such as ketoconazole or protease inhibitors; Treatment with a strong inducer of cytochrome P450 3A4, such as rifampicin, phenytoin, phenobarbital, or carbamazepine.
* Anemia
* Pregnancy or breastfeeding or women of reproductive age not using effective contraceptive methods
* Calculated creatinine clearance bellow 30 mL/min
* Known significant liver disease or alanine aminotransferase N3× the upper limit of normal
* Previous participation in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02303795
Study Brief:
Protocol Section:
NCT02303795