AzTrials
AzTrials

Atrial FibrillationORIGAMINCT04271293

Oral Anti-coagulants in Fragile Patients With Percutaneous Endoscopic Gastrostomy and Atrial Fibrillation (ORIGAMI) Pilot Study

An observational study of Atrial Fibrillation, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Compelling evidences support the safety of direct oral anticoagulants (DOAC) compared to Vitamin K antagonists (VKA) in patients with non-valvular atrial fibrillation. The 2018 EHRA/ESC practical guide on the use of non-vitamin K antagonist oral anticoagulants stated that "data have shown that administration in a… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Edoxaban
Type of treatment
Pill or oral medicine
How many people
12 participants
Where
1 siteItaly
Study dates
7 Apr 2020to 10 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with Atrial Fibrillation. Patients with PEG and indication for treatment with long-term oral anticoagulant therapy according to the guidelines.

Who may be able to join

  • Patients with PEG and indication for treatment with long-term oral anticoagulant therapy
  • Patients with Atrial Fibrillation

Who cannot join

  • Children under 18 years old.
  • Life expectancy <30 days.
  • Lack of informed consent.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168

Other trials in Italy

About this study

Official title: anticOagulanti oRali in pazIenti fraGili Con gAstrostoMia endoscopIca Percutanea e fIbrillazione Atriale

Compelling evidences support the safety of direct oral anticoagulants (DOAC) compared to Vitamin K antagonists (VKA) in patients with non-valvular atrial fibrillation. The 2018 EHRA/ESC practical guide on the use of non-vitamin K antagonist oral anticoagulants stated that "data have shown that administration in a crushed form (e.g. via a nasogastric tube), does not alter the bioavailability for apixaban, rivaroxaban, and edoxaban". However, at the moment, there are no evidences supporting unequivocally the use of DOAC via PEG.

The purpose of this study is to evaluate the safety and efficacy of Edoxaban administered through PEG in patients with an indication of anticoagulation according to the current clinical practice.

Read the detailed description

Several studies support the safety of direct oral anticoagulants (DOAC) compared to Vitamin K antagonists (VKA) in patients with non-valvular atrial fibrillation.

The 2018 EHRA/ESC practical guide on the use of non-vitamin K antagonist oral anticoagulants affirmed that "data have shown that administration in a crushed form (e.g. via a nasogastric tube), does not alter the bioavailability for apixaban, rivaroxaban, and edoxaban". However, at the moment, there are no evidences supporting unequivocally the use of DOAC via Percutaneous endoscopic gastrostomy (PEG).

PEG is a method developed throughout the early 1980s for patients who need long-term enteral nutrition due to neurodegenerative, neuromuscular and oncological diseases. This class of patients is expected to increase significantly in the next decade.

Several studies have proven the safety of DOAC compared to VKA even recommending to prefer DOAC over VKA wherever possible in the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. However, there is no evidence to support unequivocally the use of DOAC in patients fed PEG.

The purpose of this study is to evaluate the safety and efficacy of Edoxaban administered through PEG in patients with an indication of anticoagulation according to the current clinical practice.

Being tested
Edoxaban
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EdoxabanDrug

    Edoxaban will be administered via PEG in patients who are eligible for the anticoagulant treatment according to the current guidelines.

Study groups in NCT04271293
Study groupRoleWhat they receive
Patients with PEG and oral anticoagulan treatmentPatients with PEG and indication for treatment with long-term oral anticoagulant therapy due to non valvular atrial fibrillation (FNAV), according to the current guidelines.
Receives: Drug: Edoxaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardio-embolic events

    Description of the number of stroke, TIA and systemic embolism events symptomatic relapse of deep vein thrombosis/ pulmonary embolism in patients treated with Edoxaban via PEG.

    Measured: 1 month

Secondary outcomes (2)

  1. Bleeding events

    any bleeding described according to the Bleeding Academic Research Consortium (BARC) scale.

    Type 0= No bleeding

    Type 1 = Bleeding that is not actionable and does not cause the patient to seek treatment.

    Type 2 = hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional.

    Type 3a = bleeding plus hemoglobin drop of 3 to < 5 g/dl; transfusion with overt bleeding.

    Type 3b = bleeding plus hemoglobin drop < 5 g/dL; cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents.

    Type 3c = Confirmed Intracranial hemorrhage or intraocular bleed compromising vision

    Type 4 = CABG-related bleeding within 48 hours

    Type 5a = Probable fatal bleeding

    Type 5b = Definite fatal bleeding Type 0-2 will be conisdered minor bleedings. Type 3-5 will be considered major bleedings

    Measured: 1 month

  2. Anti-factor Xa assay

    Description of the efficacy of the edoxaban by measuring th the anti-FXa activity.

    Measured: within 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study start7 Apr 2020
  3. Primary completion20 Jul 2021
  4. Study completion10 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04271293
Sponsor's protocol ID
2897
Acronym
ORIGAMI
Status last verified
Oct 2021
First submitted
11 Feb 2020
Last updated
1 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Steffel J, Verhamme P, Potpara TS, Albaladejo P, Antz M, Desteghe L, Haeusler KG, Oldgren J, Reinecke H, Roldan-Schilling V, Rowell N, Sinnaeve P, Collins R, Camm AJ, Heidbuchel H; ESC Scientific Document Group. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J. 2018 Apr 21;39(16):1330-1393. doi: 10.1093/eurheartj/ehy136.

    PubMed 29562325

  • Salmonson T, Dogne JM, Janssen H, Garcia Burgos J, Blake P. Non-vitamin-K oral anticoagulants and laboratory testing: now and in the future: Views from a workshop at the European Medicines Agency (EMA). Eur Heart J Cardiovasc Pharmacother. 2017 Jan;3(1):42-47. doi: 10.1093/ehjcvp/pvw032. Epub 2016 Dec 25.

    PubMed 28025213

  • Tripodi A, Ageno W, Ciaccio M, Legnani C, Lippi G, Manotti C, Marcucci R, Moia M, Morelli B, Poli D, Steffan A, Testa S. Position Paper on laboratory testing for patients on direct oral anticoagulants. A Consensus Document from the SISET, FCSA, SIBioC and SIPMeL. Blood Transfus. 2018 Sep;16(5):462-470. doi: 10.2450/2017.0124-17. Epub 2017 Sep 13.

    PubMed 29106357

  • Galli M, D'Amario D, Andreotti F, Porto I, Vergallo R, Sabatelli M, Lancellotti S, Meleo E, De Cristofaro R, Crea F. Sustained safe and effective anticoagulation using Edoxaban via percutaneous endoscopic gastrostomy. ESC Heart Fail. 2019 Aug;6(4):884-888. doi: 10.1002/ehf2.12434. Epub 2019 Jun 11.

    PubMed 31184800

  • Cappannoli L, Laborante R, Galli M, Canonico F, Ciliberti G, Restivo A, Princi G, Arcudi A, Sabatelli M, De Cristofaro R, Crea F, D'Amario D. Feasibility, effectiveness, and safety of edoxaban administration through percutaneous endoscopic gastrostomy: 12-months follow up of the ORIGAMI study. Front Cardiovasc Med. 2022 Dec 22;9:1052053. doi: 10.3389/fcvm.2022.1052053. eCollection 2022.

    PubMed 36620634

  • D'Amario D, Galli M, Canonico F, Restivo A, Arcudi A, Scacciavillani R, Cappannoli L, Riccioni ME, Annetta MG, Di Stefano G, Piccinni C, Vergallo R, Montone RA, Leone AM, Niccoli G, Sabatelli M, Antonelli M, Andreotti F, De Cristofaro R, Crea F. ORal anticoagulants In fraGile patients with percutAneous endoscopic gastrostoMy and atrIal fibrillation: the (ORIGAMI) study. J Cardiovasc Med (Hagerstown). 2021 Mar 1;22(3):175-179. doi: 10.2459/JCM.0000000000001142.

    PubMed 33186237

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardio-embolic events (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04271293, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in