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Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress

Study acronym: ASPIRE-AF
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 37 words Study description revised · Study title expanded, about 1 wordv14 Show 2 more changesShow less
    • Study description revised
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 90 to 105v13
  3. Primary completion date: Dec 2026 to Dec 2028 Study sites: 93 to 90v12 Show 1 more changeShow less
    • Study sites: 93 to 90
  4. Enrollment target: 2800 to 2270 Primary completion date: Sep 2026 to Dec 2026 · Completion date: Dec 2026 to Dec 2028 · Eligibility criteria expanded, about 67 words · 3 morev11 Show 6 more changesShow less
    • Primary completion date: Sep 2026 to Dec 2026
    • Completion date: Dec 2026 to Dec 2028
    • Eligibility criteria expanded, about 67 words
    • Secondary endpoints: details revised at 8 of 8 entries
    • Site details revised at 9 of 93 sites
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 71 to 93v10
Show 8 earlier versionsHide 8 earlier versions
  1. Site details revised at 1 of 71 sitesv9
  2. Study sites: 47 to 71 Study title shortened, about 1 wordv8 Show 1 more changeShow less
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 4 of 47 sitesv7
  4. Study sites: 11 to 47 Interventions: Investigators can choose from one of four Non-vitamin K oral anticoagulants (NOACs): Edoxaban 60mg daily, Apixaban 5mg twice daily… to Non-vitamin K oral anticoagulant (NOAC) (Drug) · Study description shortened, about 11 wordsv6 Show 2 more changesShow less
    • Interventions: Investigators can choose from one of four Non-vitamin K oral anticoagulants (NOACs): Edoxaban 60mg daily, Apixaban 5mg twice daily… to Non-vitamin K oral anticoagulant (NOAC) (Drug)
    • Study description shortened, about 11 words

    See this version in full on ClinicalTrials.gov ↗

  5. Phase: Phase 3 to Phase 4 Enrollment target: 100 to 2800 · Primary completion date: Feb 2022 to Sep 2026 · Primary endpoints: 4 to 2 · 5 morev5 Show 8 more changesShow less
    • Enrollment target: 100 to 2800
    • Primary completion date: Feb 2022 to Sep 2026
    • Primary endpoints: 4 to 2
    • Study sites: 10 to 11
    • Completion date: Feb 2022 to Dec 2026
    • Secondary endpoints: 6 to 8
    • Study description expanded, about 14 words
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  6. Lead sponsor: McMaster University to Population Health Research Institute Study sites: 6 to 10 · Collaborators: 2 to 1v4 Show 2 more changesShow less
    • Study sites: 6 to 10
    • Collaborators: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  7. Site details revised at 3 of 6 sites Study title expanded, about 13 wordsv3 Show 1 more changeShow less
    • Study title expanded, about 13 words

    See this version in full on ClinicalTrials.gov ↗

  8. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 6 · Start date changed from estimate of Jun 2019 to Jun 14, 2019v2 Show 2 more changesShow less
    • Study sites: 0 to 6
    • Start date changed from estimate of Jun 2019 to Jun 14, 2019
  1. 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.
Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient atrial fibrillation occurring transiently with stress and additional stroke risk factors.
Trial Details
NCT Number NCT03968393
Lead Sponsor Population Health Research Institute
Collaborators: Hamilton Health Sciences Corporation
Conditions Stroke, Atrial Fibrillation
Enrollment 2,270 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov