Tests two rivaroxaban doses in people with atrial fibrillation
Tests rivaroxaban 15 mg or 20 mg in people with irregular heartbeat.
Plain-language title generated from the registry record
Registry title: Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation
Key facts
- Where
- Seoul, South KoreaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 99 years old?
Source: NCT06187311, who can take part
Where in South Korea
- Korea University Anam HospitalSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Korea University Anam Hospital
- Trial code
- NCT06187311
- Record updated
- 5 January 2024
- Original description
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.Read full original descriptionShow less
A Randomized, Open-labelled, Investigator-initiated Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation
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.
Inclusion: 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: 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; 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; Stroke requiring combination of antiplatelet drugs when treating acute coronary syndrome or a patient with a history of transient ischemic attacks; Patients with uncontrolled hypertension (systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg); Galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption a patient with genetic problems such as a disability; Patients who are overreacting to the main or components of Rivaroxaban.