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

Recruiting now · Phase 4

Conditions studied: Atrial Fibrillation, Anticoagulant Adverse Reaction

In brief

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.

Key facts

Study ID

NCT06187311

Run by

Korea University Anam Hospital

People needed

940

Starts

2023-01-12

Expected to finish

2027-06-30

Last updated by the study team

2024-01-05

Who can join

Age: 19 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 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

You may not qualify 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 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

• Korea University Anam Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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