Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation
Recruiting · NCT06187311 · Interventional (participants receive a specific treatment) · Lead sponsor: Korea University Anam Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion 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
Exclusion criteria
- 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 Arteriovenous malformations
- ⑧ Vascular aneurysms
- ⑨ Patients with malignant tumors (Neoplasm) at high risk of bleeding
- 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)
Where it is running
1 location listed.
- Korea University Anam Hospital - Seoul, South Korea