Evaluating Rivaroxaban for Atrial Fibrillation Patients
A Randomized, Open-labelled, Investigator-initiated Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation
This study is testing two different doses of Rivaroxaban to see which one works better for preventing strokes in people with non-valvular atrial fibrillation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 940 (estimated) |
| Ages | 19 Years to 99 Years |
| Sex | All |
| Sponsor | Korea University Anam Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06187311 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 years with confirmed atrial fibrillation and a CHA2DS2-VASC score indicating a need for anticoagulation.
Not a fit: Patients with moderate mitral valve stenosis, significant bleeding disorders, or severe liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide insights into the most effective dosing of Rivaroxaban for patients with non-valvular atrial fibrillation, potentially improving patient outcomes.
How similar studies have performed: Previous studies have shown positive outcomes with Rivaroxaban in similar patient populations, indicating a potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.