Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04874428 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in Patients With Liver Cirrhosis

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jun 2026 → Dec 2026
See other at-risk trials from Insel Gruppe AG, University Hospital Bern

Record History

  1. Primary and study completion pushed from Jun 2026 to Dec 2026v7
  2. Re-verified, no change to tracked fieldsv6
  3. Primary and study completion dates: Jan 2026 to Jun 2026v5
  4. Primary and study completion dates: Dec 2021 to Jan 2026v4
  5. Start date changed from estimate of May 2021 to May 19, 2021v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The aim of this study is to investigate the pharmacokinetic and pharmacodynamic parameters of rivaroxaban and apixaban in patients with compensated liver cirrhosis (Child-Pugh class A and B). The enrolled participants receive a prophylactic single oral dose of either rivaroxaban (10 mg) or apixaban (2.5 mg) at around 8 a.m. on the day of the trial. Blood samples are taken 0.5 hours pre-dose and 1, 2, 3, 4, 6, 8, 12 hours post-dose. A follow-up telephone call is performed 5 days after the study intervention to collect safety data.
Trial Details
NCT Number NCT04874428
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Collaborators: Centre Hospitalier Universitaire Vaudois
Conditions
(from sponsor)		 Liver Cirrhosis
Related terms Cardiovascular Diseases, Embolism and Thrombosis, Liver Cirrhosis, Liver Diseases, Thromboembolism, Vascular Diseases, Venous Thromboembolism
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov