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Tests treatment safety and results for Atrial Fibrillation
Official title Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation
ClinicalTrials.gov ID: NCT06187311
What this study is testing
What is Rivaroxaban 20 MG?
Rivaroxaban 20 MG is an investigational medicine, given as an once-daily, being studied as a potential treatment for atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 99
You may be able to join if
- adult men and women over 19 years of age when screening
- A person whose atrial fibrillation has been confirmed by electrocardiogram during screening and baseline.
- Anticoagulants for the prevention of stroke or systemic embolism For cases where medication is required, a person with a CHA2DS2-VASC score of 1...
- 4) CrCl (Creatinine Clearance) ≥50 ml/min
- A person who voluntarily agrees in writing to this study
You likely can't join if
- Moderate mitral valve stenosis or mechanical artificial valve A person with a history of mechanical valve
- Thyroid disease, terminal hypertrophy, brown cytoplasm, adrenal glands that affect the occurrence of atrial fibrillation A person accompanied by...
- clinically significant bleeding (e.g., intracranial bleeding, gastrointestinal bleeding)
- Clinical significance of liver disease related to blood coagulation disorder and Child Pugh B and C liver disease associated with the risk of bleeding
- Patients with increased risk of bleeding due to the following conditions:
- Gastrointestinal ulcer history within 6 months prior to random allocation
See the full eligibility criteria
- adult men and women over 19 years of age when screening
- A person whose atrial fibrillation has been confirmed by electrocardiogram during screening and baseline.
- 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) CrCl (Creatinine Clearance) ≥50 ml/min
- A person who voluntarily agrees in writing to this study
- Moderate mitral valve stenosis or mechanical artificial valve A person with a history of mechanical valve
- 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.
- clinically significant bleeding (e.g., intracranial bleeding, gastrointestinal bleeding)
- Clinical significance of liver disease related to blood coagulation disorder and Child Pugh B and C liver disease associated with the risk of bleeding
- 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...
- Stroke requiring combination of antiplatelet drugs when treating acute coronary syndrome or a patient with a history of transient ischemic attacks
- Patients who are overreacting to the main or components of Rivaroxaban
- Galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption a patient with genetic problems such as a disability
- Patients with uncontrolled hypertension (systolic BP \> 180 mm Hg or diastolic BP \> 100 mm Hg)
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.