Actively Recruiting
Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation
Led by Korea University Anam Hospital · Updated on 2024-01-05
940
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men and women over 19 years of age at screening
- Confirmed atrial fibrillation by electrocardiogram at screening and baseline
- Need for anticoagulants to prevent stroke or systemic embolism with CHA2DS2-VASC score of 1 for males or 2 or more for females
- Creatinine clearance (CrCl) of 50 ml/min or higher
- Voluntary written consent to participate in the study
You will not qualify if you...
- Moderate mitral valve stenosis or history of mechanical artificial heart valve
- Presence of thyroid disease, terminal hypertrophy, adrenal gland disorders, or related conditions affecting atrial fibrillation
- History of clinically significant bleeding such as intracranial or gastrointestinal bleeding
- Liver disease affecting blood clotting, including Child Pugh B or C liver disease
- Increased bleeding risk due to recent gastrointestinal ulcers, brain or spinal hemorrhage, vascular abnormalities, recent brain/spinal surgery, brain or spinal injury, esophageal varices, arteriovenous malformations, vascular aneurysms, or high-risk malignant tumors
- Stroke requiring combined antiplatelet drugs or history of transient ischemic attacks
- Allergy or overreaction to Rivaroxaban or its components
- Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption problems
- Uncontrolled high blood pressure with systolic >180 mm Hg or diastolic >100 mm Hg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Korea University Anam Hospital
Seoul, South Korea, 02841
Actively Recruiting
Research Team
J
Jong-il Choi, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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