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EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation

RECRUITINGN/ASponsored by Azienda Ospedaliero Universitaria Maggiore della Carita
Actively Recruiting
PhaseN/A
SponsorAzienda Ospedaliero Universitaria Maggiore della Carita
Started2024-02-01
Est. completion2025-01-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06285942

Summary

The goal of this interventional study is to describe the use of Edoxaban via PEG in patients with an indication to anticoagulation therapy. One arm will receive Edoxaban through PEG and the other arm will receive other Direct oral anticoagulants through PEG or subcutaneous heparin or LMWH. Once enrolled, patients will be treated with a single daily dose of Edoxaban (60 or 30 mg according to specific indications). At day 4 after enrollment (steady state), evaluation of anti-FXa activity and thrombin generation assay will be performed on peripheral whole blood samples. At months 6 and 12 patients will be asked to complete the ACTS (Anti-Clot treatment scale) questionnaire specific for anticoagulation. The main endpoint will be: the difference in the results of the Anti-Clot treatment scale questionnaire between the two groups evaluated at 12 months.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* PEG (recent implantation or already present)
* Indication for long-term oral anticoagulation

Exclusion Criteria:

* Under 18 years of age
* Life expectancy \<30 days
* Lack of informed consent
* Contraindication to DOACs

Conditions3

Atrial FibrillationFragilityHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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