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DOAC in Patients with Child a or B Liver Cirrhosis

Study acronym: CIRROAC
StatusRecruiting
PhasePhase 2
Started
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Record status
This record was last updated February 13, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: May 2025 to Jun 2026v4
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 7 more changesShow less
    • Enrollment target: 32 to 40
    • Study sites: 0 to 1
    • Primary and study completion dates: Jan 2025 to May 2025
    • Start date changed from estimate of Oct 2023 to Jan 18, 2024
    • Secondary endpoints revised (7)
    • Eligibility criteria shortened, about 3 words
    • Study title expanded, about 2 words
  3. Start date: Jul 2023 to Oct 2023v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to investigate pharmacokinetics and pharmacodynamics of direct oral anticoagulant drugs (DOAC), specifically apixaban and edoxaban, in patients with Child A or B liver cirrhosis (LC). The primary objective of this study is to verify the ability of apixaban and edoxaban to decrease in vivo thrombin generation in LC patients. Participants will be randomly assigned to either apixaban (Eliquis®) or edoxaban (Lixiana®) at a therapeutic dosage for 7 consecutive days. The results of this investigation will contribute to designing a prospective multicentre interventional study to investigate the efficacy of DOAC to improve clinical outcomes in patients with LC
Trial Details
NCT Number NCT05869591
Lead Sponsor Centre Hospitalier Universitaire Vaudois
Conditions
(from sponsor)		 Liver Cirrhosis
Related terms Fibrosis, Liver Cirrhosis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov