Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06187311
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-16
Brief Title:
Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation
Sponsor:
Korea University Anam Hospital
Organization:
Korea University Anam Hospital
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVISE-AF
Brief Summary:
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 11 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 36912 months will be made and follow-up test and outcome measurement will be done in each visit
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 11 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 36912 months will be made and follow-up test and outcome measurement will be done in each visit
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None