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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT06402851
Eligibility Criteria:
Inclusion Criteria:
* Patients with clinical atrial fibrillation or flutter (persistent, paroxysmal or permanent);
* CHA2DS2-Vasc ≥ 2 points (≥ 3 if female);
* Chronic kidney disease with estimated glomerular filtration rate (eGFR) ≤ 15 ml/min/1.73 m2 by the CKD-EPI equation (confirmed by two lab results at least 3 months apart) or on chronic renal replacement therapy (Of note: number of patients included in no renal replacement therapy stratum will be capped at around 30% from the total study population).
Exclusion Criteria:
* Active bleeding or severe bleeding \< 1 month;
* Prior kidney transplantation;
* Refusal de provide consent
* Severe chronic liver disease (Child C);
* Other indication of oral anticoagulation (e.g.,: venous thromboembolism or pulmonary embolism);
* Prior intracranial hemorrhage;
* Bleeding disorder (other than uremia);
* Platelet count \< 50,000 / mm3 ;
* Pregnancy or breastfeeding;
* Mechanical valvar prosthesis;
* Moderate to severe mitral stenosis;
* Need for antithrombotic drugs other than single antiplatelet agents, or need for dual antiplatelet therapy with aspirin plus an ADP receptor blocker;
* Any comorbidity beyond CKD and CV disease (e.g., metastatic cancer) which, in the investigator´s opinion, may impact survival in 12 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06402851
Study Brief:
Protocol Section:
NCT06402851