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

Korea University

Status and phase: Enrolling; Phase 4

Conditions: Atrial Fibrillation; Anticoagulant Adverse Reaction

Treatments: Drug: Rivaroxaban 15 MG; Drug: Rivaroxaban 20 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06187311

2023AN0034

Details and patient eligibility

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.

Enrollment: 940 estimated patients

Sex: All

Ages: 19 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. adult men and women over 19 years of age when screening
2. A person whose atrial fibrillation has been confirmed by electrocardiogram during screening and baseline.
3. 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. 4. CrCl (Creatinine Clearance) ≥50 ml/min
5. A person who voluntarily agrees in writing to this study

Exclusion criteria

1. Moderate mitral valve stenosis or mechanical artificial valve A person with a history of mechanical valve

2. 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.

3. clinically significant bleeding (e.g., intracranial bleeding, gastrointestinal bleeding)

4. Clinical significance of liver disease related to blood coagulation disorder and Child Pugh B and C liver disease associated with the risk of bleeding

5. 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

6. Stroke requiring combination of antiplatelet drugs when treating acute coronary syndrome or a patient with a history of transient ischemic attacks

7. Patients who are overreacting to the main or components of Rivaroxaban

8. Galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption a patient with genetic problems such as a disability

9. Patients with uncontrolled hypertension (systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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940 participants in 2 patient groups

Rivaroxaban 15mg

Experimental group

Description:

Subjects eligible for this clinical trial will be randomly assigned to Group 1 (15 mg of rivaroxaban) or Group 2 (20 mg of rivaroxaban) at baseline visits in a 1:1 ratio.

Treatment:

Drug: Rivaroxaban 15 MG

Rivaroxaban 20mg

Experimental group

Description:

Subjects eligible for this clinical trial will be randomly assigned to Group 1 (15 mg of rivaroxaban) or Group 2 (20 mg of rivaroxaban) at baseline visits in a 1:1 ratio.

Treatment:

Drug: Rivaroxaban 20 MG