Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.
Manesh R Patel, Kenneth W Mahaffey, Jyotsna Garg...
https://pubmed.ncbi.nlm.nih.gov/21830957Actively Recruiting
Phase 4
Age: 19Years - 99Years
All Genders
ID06187311
A Randomized, Open-labelled 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two different doses of Rivaroxaban (15 mg and 20 mg daily) in adults with non-valvular atrial fibrillation who do not have severe kidney problems. This phase 4, randomized, open-label study aims to compare these doses to understand their impacts on preventing stroke and systemic embolism while monitoring bleeding risks. Participants with confirmed atrial fibrillation and a qualifying risk score are included to ensure appropriate study conditions. Participants will be randomly assigned to receive either 15 mg or 20 mg of Rivaroxaban once daily for 12 months. After providing consent and completing screening tests including electrocardiograms and lab tests to exclude severe organ dysfunction, eligible participants begin treatment at a baseline visit. Follow-up visits occur at 3, 6, 9, and 12 months to monitor treatment effects and collect data. During the study, participants will undergo regular tests including blood work, vital sign checks, and electrocardiograms to monitor safety and treatment adherence. The main measurement will be the rate of major bleeding events at multiple time points throughout the year. Secondary outcomes include monitoring occurrences of stroke, embolism, heart attacks, deaths, and other bleeding events. Researchers will also track any unexpected medical visits and how consistently participants take their medication.
CONDITIONS
Brief Title
Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation
Who Can Participate
Age: 19Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adult men and women aged 19 years or older
- 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 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
- Thyroid disease, terminal hypertrophy, adrenal gland disorders, parathyroid disease, pancreatic disease affecting atrial fibrillation
- Clinically significant bleeding such as intracranial or gastrointestinal bleeding
- Liver disease affecting blood clotting or Child Pugh B and C liver disease
- Increased bleeding risk due to recent gastrointestinal ulcers, brain or spinal hemorrhage, vascular abnormalities, recent brain/spinal/eye surgery, brain or spinal injury within 6 months
- Suspected or diagnosed esophageal varices, arteriovenous malformations, vascular aneurysms
- High risk malignant tumors
- Stroke requiring combination antiplatelet drugs or history of transient ischemic attacks
- Allergy to Rivaroxaban or its components
- Genetic disorders like galactose intolerance, lactase deficiency, or glucose-galactose absorption problems
- Uncontrolled hypertension with systolic BP over 180 mm Hg or diastolic BP over 100 mm Hg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants take either 15 mg or 20 mg of rivaroxaban once daily according to their random assignment to reduce the risk of stroke or systemic embolism.
Visits at baseline and approximately every 3 months during treatment
Trial Site Locations
Total: 1 location
1
Korea University Anam Hospital
Seoul, South Korea, 02841
Actively Recruiting
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Research Team
J
Jong-il Choi, MD, PHD
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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Published Research Related To This Trial
Rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation – the J-ROCKET AF study –.
Masatsugu Hori, Masayasu Matsumoto, Norio Tanahashi...
https://pubmed.ncbi.nlm.nih.gov/22664783Outcomes After Use of Standard- and Low-Dose Non-Vitamin K Oral Anticoagulants in Asian Patients With Atrial Fibrillation.
Min Soo Cho, Ji Eun Yun, Ji Jeong Park...
https://pubmed.ncbi.nlm.nih.gov/30580716Effectiveness and Safety of Standard- and Low-Dose Rivaroxaban in Asians With Atrial Fibrillation.
Yi-Cheng Lin, Shu-Chen Chien, Yi-Chen Hsieh...
https://pubmed.ncbi.nlm.nih.gov/30049307Comparisons of Rivaroxaban Following Different Dosage Criteria (ROCKET AF or J-ROCKET AF Trials) in Asian Patients With Atrial Fibrillation.
Yi-Hsin Chan, Hsin-Fu Lee, Chun-Li Wang...
https://pubmed.ncbi.nlm.nih.gov/31623498