NCT06187311RecruitingPhase 4
Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation
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
Source: ClinicalTrials.gov · Last updated 5 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 940 (estimated)
- First submitted
- 16 Dec 2023
- Start date
- 12 Jan 2023
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Korea University Anam Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT06187311
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 940
- From 12 Jan 2023 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
Lab values
- Galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption a patient with genetic problems such as a disability
Other
- Patients who are overreacting to the main or components of Rivaroxaban
Who the study is looking for
- 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
Age in the registry: 19 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.