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Avoiding Anticoagulation After IntraCerebral Haemorrhage

Study acronym: A3ICH
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Jan 2026 to Jan 2029
    • Study completion date: Dec 2028 to Dec 2029
    v8
  2. Primary completion date: Dec 2026 to Jan 2026
    • Study completion date: Dec 2026 to Dec 2028
    • Start date: Jan 24, 2019 to Jan 17, 2019
    v7
  3. Primary and study completion dates: Dec 2023 to Dec 2026v6
  4. Study sites: 1 to 3
    • Eligibility criteria expanded, about 6 words
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Dec 2022 to Dec 2023
    • Start date changed from estimate of Sep 2018 to Jan 24, 2019
    • Study sites: 0 to 1
    v4
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  1. Start date: Mar 2018 to Sep 2018v3
  2. Start date: Dec 2017 to Mar 2018v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Randomised controlled trials (RCTs) demonstrate a substantial benefit from oral anticoagulant drugs for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation (AF). However, these RCTs excluded patients with prior intracerebral haemorrhage (ICH). Therefore, guidelines are unable to recommend whether oral anticoagulant drugs, in particular non-vitamin K antagonist (called direct OAC) - can be used for patients with AF after an intracerebral haemorrhage. Roughly 30% of adults with ICH have AF but in 2017 it remains unclear whether they should start oral anticoagulant drugs, be treated with left atrial appendage closure (LAAC) or avoid anticoagulation and LAAC.
Trial Details
NCT Number NCT03243175
Lead Sponsor University Hospital, Lille
Collaborators: Ministry of Health, France, Institut National de la Santé Et de la Recherche Médicale, France
Conditions
(from sponsor)		 Intracerebral Hemorrhage, Atrial Fibrillation, Microhaemorrhage
Related terms Atrial Fibrillation, Cerebral Hemorrhage
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov