STABLED Sub-study(AF screening)

JRCT ID: jRCTs032200054

Registered date:19/06/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-valvular atrial fibrillation
• Date of first enrollment: 16/07/2020
• Target sample size: 600
• Study type: Interventional
• Intervention(s): Perform screening test for atrial fibrillation with Duranta(R)

Outcome(s)

• Primary Outcome: Atrial fibrillation detection rate

Secondary Outcome

<<Confirmatory Endpoints>>
Atrial fibrillation detection time
Atrial fibrillation persistence time
Atrial fibrillation duration factor
<<Safety outcomes>>
Adverse events related to use of Duranta(R)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kimura Kazumi
• Source(s) of Monetary Support: Daiichi Sankyo Co., Ltd.