RecruitingPhase 4NCT06187311

Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation

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


Sponsor

Korea University Anam Hospital

Enrollment

940 participants

Start Date

Jan 12, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This South Korean trial compares two doses of rivaroxaban (15 mg vs. 20 mg) — a blood-thinning medication — in adults with atrial fibrillation (an irregular heartbeat) to prevent stroke and blood clots. The aim is to find which dose is safer and more effective for Korean patients. **You may be eligible if...** - You are 19 years or older - You have been diagnosed with non-valvular atrial fibrillation confirmed by ECG - Your doctor has determined you need blood thinners to prevent stroke (based on your risk score) - You have not yet started rivaroxaban, or you are being switched from another anticoagulant **You may NOT be eligible if...** - You have a mechanical heart valve or significant valvular heart disease - You have active serious bleeding or a high bleeding risk - You have severe kidney or liver problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRivaroxaban 20 MG

Subjects should take clinical trial drugs (20 mg of rivaroxaban) for each group of administration once a day for 12 months, according to random assignments.

DRUGRivaroxaban 15 MG

Subjects should take clinical trial drugs (15 mg of rivaroxaban) for each group of administration once a day for 12 months, according to random assignments.


Locations(1)

Korea University Anam Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06187311


Related Trials