STABLED Sub-study(AF screening)
Phase 4
- Conditions
- on-valvular atrial fibrillation
- Registration Number
- JPRN-jRCTs032200054
- Lead Sponsor
- Kimura Kazumi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
1)Age >=20 and =<85 years at time of giving informed consent
2) Potentially Nonvalvular atrial fibrillation
3)History of ischemic stroke in previous 6 months
4)Modified Rankin Scale (mRS) =<3
Exclusion Criteria
1)Presence of severe renal disorder(estimated creatinine clearance <30 mL/min by Cockroft-Gault equation)
2)Patient with clearly impaired heart function (ER =<35%)
3)Atrial septal defect (ASD)
4)Pregnant or possibility of pregnancy
5)Unlikely to complete the study, such as due to progressive malignant tumor
6)Participating or planning to participate in another interventional clinical trial
7)Unwilling to participate
8)Judged as incompatible for the study by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Atrial fibrillation detection rate
- Secondary Outcome Measures
Name Time Method <<Confirmatory Endpoints>><br>Atrial fibrillation detection time<br>Atrial fibrillation persistence time<br>Atrial fibrillation duration factor<br><<Safety outcomes>><br>Adverse events related to use of Duranta(R)