NCT06187311 Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation
| NCT ID | NCT06187311 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Korea University Anam Hospital |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 940 participants |
| Start Date | 2023-01-12 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 940 participants in total. It began in 2023-01-12 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this clinical trial, Rivaroxaban of standard dose (20mg) and reduced dose (15mg) will be administeted in non-valvular atrial fibrillation patients without severe renal dysfunction. It is a randomized, open-label, and phase 4 clinical trial to compare and evaluate efficacy and safety of Rivaroxaban. After obtaining informed consent to participate in this trial, screening is performed (Screening visit). Screening includes baseline 12-lead electrocardiography and laboratory tests to exclude severe end-organ dysfunction (such as renal dysfunction, liver dysfunction, or anemia). Baseline visits are available on the same day. After screening, subjects eligible for the trial will be randomly assigned (1:1 ratio) to Group 1 (15 mg of Rivaroxaban) or Group 2 (20 mg of Rivaroxaban) (Baseline visit). The study drug (Rivaroxaban 15mg or 20mg daily) will be administered for 12 months. During study period, a total of six visits (3,6,9,12 months) will be made, and follow-up test and outcome measurement will be done in each visit.
Eligibility 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)
Contact & Investigator
Jong-il Choi, MD, PHD
PRINCIPAL INVESTIGATOR
Korea University
Frequently Asked Questions
Who can join the NCT06187311 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 99 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06187311 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06187311 currently recruiting?
Yes, NCT06187311 is actively recruiting participants. Contact the research team at jongilchoi@korea.ac.kr for enrollment information.
Where is the NCT06187311 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06187311 clinical trial?
NCT06187311 is sponsored by Korea University Anam Hospital. The principal investigator is Jong-il Choi, MD, PHD at Korea University. The trial plans to enroll 940 participants.
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