Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke

Study acronym: CANDLE-AF
StatusTerminated
PhaseNot applicable
Started

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Record History

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  1. Re-verified, no change to tracked fields
  2. Trial terminated Sponsor's reason: Enrollment was closed early in July 2025 because of slow recruitment (338 of 600 planned participants; 324 were required for the superiority comparison). The 12-month follow-up period for all randomized participants ended in July 2026. Show 9 more changesShow less
    • Primary completion pushed from Nov 1, 2025 to Jul 8, 2026
    • Primary endpoint(s) modified
    • Study completion date changed from estimate of Nov 15, 2026 to Jul 8, 2026
    • Interventions modified
    • Enrollment target: 337 to 338
    • Study sites: 9 to 7
    • Eligibility criteria expanded, about 107 words
    • Secondary endpoints: 4 to 5
    • Collaborators: 1 to 4
  3. Primary completion date changed from estimate of Sep 18, 2024 to Nov 1, 2025v6 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 600 to confirmed 337
    • Study completion date: Sep 18, 2025 to Nov 15, 2026
    • Secondary endpoints: 2 to 4
    • Site details revised at 9 of 9 sites
  4. Study sites: 6 to 9v5
  5. Lead sponsor: [Redacted] to Ewha Womans University Mokdong Hospitalv4 Show 6 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary completion date: Sep 18, 2024
    • Study completion date: Sep 18, 2025
    • Start date: Nov 17, 2020
    • Collaborators expanded, about 5 words
    • Study title expanded, about 1 word
  6. 2 versions Re-verified since May 31, 2021, no change to tracked fieldsv2-v3
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Atrial fibrillation (AF) detected after ischemic stroke has immediate therapeutic implications, because it prompts a switch from antiplatelet to anticoagulant therapy. The conventional method used to screen for AF in patients whose stroke has no identified cause (cryptogenic stroke) is 24-hour Holter monitoring. CANDLE-AF is a multicenter, open-label, randomized trial comparing three noninvasive monitoring strategies over 12 months in patients with cryptogenic ischemic stroke or transient ischemic attack and no known AF: physician-directed standard care (at least one 24- to 72-hour Holter recording), scheduled 72-hour single-lead patch ECG monitoring repeated at 1, 3, 6, and 12 months, and twice-daily 30-second handheld single-lead ECG recording with a smartphone-based device for 12 months. The primary outcome is detection of AF lasting 30 seconds or longer within 12 months.
Trial Details
NCT Number NCT04624646
Lead Sponsor Ewha Womans University Mokdong Hospital
Collaborators: Korea Health Industry Development Institute, National Research Foundation of Korea, Korea Medical Device Development Fund, AliveCor
Conditions
(from sponsor)		 Atrial Fibrillation, Ischemic Stroke, Transient Ischemic Attack
Related terms Atrial Fibrillation, Ischemic Attack, Transient, Ischemic Stroke
Enrollment 338 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov