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NCT03489395
A Pilot Study on Edoxaban for the Resolution of Left Atrial Thrombosis in Patients With Non-valvular Atrial Fibrillation
Phase 2 trial testing Edoxaban in Atrial Fibrillation in 25 participants. Completed in 30 April 2021.
31 December 2020
Quick facts
| Lead sponsor | Raffaele De Caterina |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 30 January 2018 |
| Primary completion | 31 December 2020 |
| Estimated completion | 30 April 2021 |
| Sites | 8 locations across Italy |
Drugs / interventions tested
- Edoxaban (edoxaban) — full drug profile →
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
Sponsor
Raffaele De Caterina
Who can join
Adults 18 to 99, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Isolated reports have indicated that complete Left Atrial or Left Atrial Appendage thrombus resolution may be achieved also with use of oral Factor Xa inhibitors, which have demonstrated the same efficacy but a better safety profile compared to warfarin. The aim of this open-label pilot study is to investigate the percentage of Left Atrial /Left Atrial Appendage thrombus resolution with edoxaban therapy in patients with non-valvular atrial fibrillation. The subordinated aim is the design a larger and longer study to compare edoxaban and warfarin in the same patient population. With the exception of few case reports, there are no data in the same patient population referred to antithrombotic treatments other than vitamin K antagonists.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Prevalence and Rate of Resolution of Left Atrial Thrombus in Patients with Non-Valvular Atrial Fibrillation: A Two-Center Retrospective Real-World Study.
Faggiano P, Dinatolo E, Moreo A, De Chiara B, et al · · 2022 · cited 10× · PMID 35329845 · DOI 10.3390/jcm11061520
Verify or expand the search:
- PubMed search for NCT03489395
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT05732506 — Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria · completed
- NCT05540587 — Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis · Phase 2 · recruiting
Other recruiting trials for Atrial Fibrillation
Currently open trials in the same condition.
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Other Raffaele De Caterina trials
Trials by the same sponsor.
- NCT06270498 — Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03489395 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Raffaele De Caterina
- Last refreshed: 4 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03489395.
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