Evaluating Rivaroxaban for Atrial Fibrillation Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of two doses of Rivaroxaban (15mg and 20mg) in patients with non-valvular atrial fibrillation. It is a randomized, open-label, phase 4 trial that includes screening for severe renal dysfunction and other end-organ issues. Eligible participants will be randomly assigned to receive one of the two doses daily for 12 months, with follow-up visits at 3, 6, 9, and 12 months to monitor outcomes. The study aims to determine the optimal dosing for preventing stroke and systemic embolism in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. adult men and women over 19 years of age when screening
2. A person whose atrial fibrillation has been confirmed by electrocardiogram during screening and baseline.
3. Anticoagulants for the prevention of stroke or systemic embolism For cases where medication is required, a person with a CHA2DS2-VASC score of 1 male/female 2 or more points (In case of one or more risk factors)
4. 4\) CrCl (Creatinine Clearance) ≥50 ml/min
5. A person who voluntarily agrees in writing to this study

Exclusion Criteria:

1. Moderate mitral valve stenosis or mechanical artificial valve A person with a history of mechanical valve
2. Thyroid disease, terminal hypertrophy, brown cytoplasm, adrenal glands that affect the occurrence of atrial fibrillation A person accompanied by cortical disease, parathyroid disease, pancreatic disease, etc.
3. clinically significant bleeding (e.g., intracranial bleeding, gastrointestinal bleeding)
4. Clinical significance of liver disease related to blood coagulation disorder and Child Pugh B and C liver disease associated with the risk of bleeding
5. Patients with increased risk of bleeding due to the following conditions:

   * Gastrointestinal ulcer history within 6 months prior to random allocation

     * Intracranial or intracranial hemorrhage history within 6 months prior to random assignment

       * vascular abnormalities in the spinal cord or brain

         * History of brain, spinal cord or ophthalmic surgery within 30 days prior to random assignment

           ⑤ Brain or spinal cord injury within 6 months prior to random allocation

           ⑥ If you have esophageal varices or are suspected

           ⑦ Arteriovenous malformations

           ⑧ Vascular aneurysms

           ⑨ Patients with malignant tumors (Neoplasm) at high risk of bleeding
6. Stroke requiring combination of antiplatelet drugs when treating acute coronary syndrome or a patient with a history of transient ischemic attacks
7. Patients who are overreacting to the main or components of Rivaroxaban
8. Galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption a patient with genetic problems such as a disability
9. Patients with uncontrolled hypertension (systolic BP \> 180 mm Hg or diastolic BP \> 100 mm Hg)

Where it's running

• Korea University Anam Hospital
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Jong-il Choi, MD, PHD — Korea University
• Study coordinator: Jong-il Choi, MD, PHD
• Email: jongilchoi@korea.ac.kr
• Phone: 02-920-6710

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

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• Identifying AF patients who may need more than standard ablation using Volta AF-Xplorer II

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.