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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT03862859
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥18 years on chronic dialysis due to end-stage renal disease
* Non-valvular paroxysmal, persistent, or permanent atrial fibrillation OR non-treated (for \>2 months) prevalent paroxysmal, persistent or permanent atrial fibrillation as documented by an electrocardiogram or an episode of ≥30 seconds on Holter monitor, or episodes ≥ 6 minutes on event recorders or any other recording device.
* Competence to understand the study rationale, including potential risks and benefits associated with treatment, necessary for written informed consent.
Exclusion Criteria:
* CHA2DS2-VASc Score ≤1
* Other indications for oral anticoagulation treatment (pulmonary embolism \< 6 months, deep vein thrombosis \<3 months, mechanical heart valve prosthesis) irrespective of whether treatment is implemented
* Ongoing dual antiplatelet treatment
* Malignancy (with exception of non-melanoma skin cancer) with recent \< 1 year, ongoing, or planned curative, or palliative chemo- , radiation-, and/or scheduled surgical therapy
* Endoscopy with gastrointestinal ulcer \<1 month
* Esophageal varices
* Autoimmune og genetic coagulation disorders
* Congenital alactasia, Lapp Lactase deficiency or glucose-galactose malabsorption
* Pending spinal tap
* Cerebrovascular malformations
* Arterial aneurysms
* Ulcers or wounds (Wagner grad \>1)
* Bacterial endocarditis \< 3 months
* Active bleeding contraindicating anticoagulation
* Any non-elective and/or non-ambulant surgery \<7 days
* Cerebral hemorrhage \<4 weeks
* Thrombocytopenia (platelet count \<100 × 109/L) \<30 days.
* Severe liver insufficiency (spontaneous international normalized ratio \>1.5) \<30 days.
* Known intolerance to warfarin
* Use of hypericum perforatum / St. John's Wort
* Uncontrolled hypertension (repeat blood pressure \>180/110 mmhg) \< 30 days
* Uncontrolled hyperthyroidism (thyroid-stimulating hormone \<0.1μIU/mL) \<30 days
* Pregnancy or lactation
* Participation in other ongoing intervention trials adjudged to influence study outcomes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03862859
Study Brief:
Protocol Section:
NCT03862859