ClinicalTrials.gg
Active, not recruitingNCT07901699RAFTING-GIBUpdated Nov 2, 2026

Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation

An observational study in Atrial Fibrillation (AF) and Major Gastrointestinal Bleeding (MGIB), sponsored by Società Italiana di Medicina Interna. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Società Italiana di Medicina Interna · Observational

Updated Nov 2, 2026Eligibility revisedPrimary outcomes revised+3 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
650
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 252 studies in Atrial Fibrillation with a site in Italy — 44 open to participants now, 64 under way, 2 of them phase 3. Atrial Fibrillation · Italy.

Planned enrollment
37th of 95
650 · median 411
Started
2024
with 13 others
Observational
95 of 252
22 open now
Primary completion
2026-11
later than 24 of 63 live
Registered
252nd of 252
by date

Among the 252 studies in Atrial Fibrillation with a site in Italy, this one is the 37th largest by planned enrollment of the 95 observational ones, is one of 14 that started in 2024, is one of 95 observational ones, reaches primary completion later than 24 of the 63 other live ones, and was the 252nd registered.

By phase

252 studies; the count open now beside each. This study's row is marked.

Observationalthis study95 · 22 open
No phase80 · 17 open
Phase 343 · 1 open
Phase 420 · 2 open
Phase 212 · 2 open
Phase 11 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2000; this study’s year is marked. 14 started in 2024.

Size and results

Median enrollment 321 across the 156 interventional studies, 411 across the 95 observational. Of the 154 that completed or were terminated, 72 (47%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 252 studies in Atrial Fibrillation with a site in Italy, or all of them as a file.
02

Study summary

Prospective multicenter observational study on resumption of anticoagulant therapy after major gastrointestinal bleeding in patients with atrial fibrillation

Read the detailed description

Prospective multicenter observational study with central blinded and independent adjudication of primary outcome on resumption of anticoagulant therapy after major gastrointestinal bleeding in patients with atrial fibrillation

03

Conditions studied

  • Atrial Fibrillation (AF)
  • Major Gastrointestinal Bleeding (MGIB)

Browse trials for

Keywords

  • Atrial Fibrillation (AF)
  • Anticogulant
  • VKI
  • DOAC
  • Major Gastointestinal Bleeding (MGIB)
04

Who can participate

The criteria were revised on the registry on Nov 2, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive patients fulfilling inclusion criteria and with no exclusion criterion

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults ≥ 18 years old
  • confirmed atrial fibrillation on treatment with VKAs or DOACs;
  • Signed ;

Exclusion criteria

Exclusion Criteria:

  • Indication for anticoagulant treatment is different from atrial fibrillation
  • Any condition deemed by the physician to endanger patient safety in case of inclusion in the study
  • Refusal of
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
650 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Major gastrointestinal bleeding as assessed by the central independent adjudication committee

    Recurrence of Major GIB at 90 days as assessed by the central independent adjudication committee

    Time frame: 90 days

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — based on a specific request

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Nov 2026, 34 months after the start.

Of 550 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 91. This study's planned 34 months is below that.

Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2026
First posted
Oct 28, 2026
StartActual
Jan 5, 2024
Primary completionEst.
Nov 2026
CompletionEst.
Dec 2026
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed
Show site
  • Azienda Ospedaliera di Perugia · Perugia, Italy
Show 1 removed
  • Università degli Studi di Perugia · Perugia, Italy
Nov 2, 2026
Eligibility
1 exclusion criterion edited
What changed in the criteria
Exclusion criteria
  • EditedIndication for anticoagulant treatment is different from atrial fibrillation
Nov 2, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedMajor gastrointestinal bleeding as assessed by the central independent adjudication committeeTime frame: 90 days
Nov 2, 2026
Registered
First appeared on the registry
Oct 28, 2026
Show all 2 updates
  1. Nov 2, 2026
    1 site added, 1 site removed
    Show site
    • Azienda Ospedaliera di Perugia · Perugia, Italy
    Show 1 removed
    • Università degli Studi di Perugia · Perugia, Italy
    Eligibility 1 exclusion criterion edited
    What changed in the criteria
    Exclusion criteria
    • EditedIndication for anticoagulant treatment is different from atrial fibrillation
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedMajor gastrointestinal bleeding as assessed by the central independent adjudication committeeTime frame: 90 days
    + 4 other changes: index terms, description, conditions and data sharing statement
  2. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07901699
Lead sponsor
Società Italiana di Medicina Interna
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Jan 5, 2024
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Nov 2, 2026

Study contacts

Cecilia Becattini, MD, PhD
principal investigator · University Of Perugia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion