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Safety and efficacy of apixaban versus warfarin in peritoneal dialysis patients with non valvular atrial fibrillation: a randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507544-37-00
Acronym
23-0164 (APIDP2)
Enrollment
178
Registered
2024-05-24
Start date
2025-01-08
Completion date
Unknown
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with end-stage renal disease on chronic peritoneal dialysis and with non-valvular atrial fibrillation

Brief summary

Clinically significant major or non-major bleeding [Period: from randomization to Month 12]. ISTH score (primary), Gusto, TIMI (secondary).

Detailed description

Stroke or systemic embolism [Period: From randomization until Month 12]., Myocardial infarction [Period: From randomization until Month 12]., Death from any cause [Period: From randomization until Month 12]., INR values, interpretation by Rosendaal method, antiXa activity of apixaban at M1, M6, M12, and in case of bleeding.

Interventions

DRUGWARFARIN
DRUGAPIXABAN

Sponsors

Centre Hospitalier Universitaire De Caen Normandie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Clinically significant major or non-major bleeding [Period: from randomization to Month 12]. ISTH score (primary), Gusto, TIMI (secondary).

Secondary

MeasureTime frame
Stroke or systemic embolism [Period: From randomization until Month 12]., Myocardial infarction [Period: From randomization until Month 12]., Death from any cause [Period: From randomization until Month 12]., INR values, interpretation by Rosendaal method, antiXa activity of apixaban at M1, M6, M12, and in case of bleeding.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 5, 2026