Atrial Fibrillation (AF)RAFTING-GIBNCT07901699
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
An observational study of Atrial Fibrillation (AF) and Major Gastrointestinal Bleeding (MGIB), run by Società Italiana di Medicina Interna at 1 site in Italy.
Trial summary
Prospective multicenter observational study on resumption of anticoagulant therapy after major gastrointestinal bleeding in patients with atrial fibrillation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Major Gastrointestinal Bleeding (MGIB)
- How many people
- 650 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jan 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Consecutive patients fulfilling inclusion criteria and with no exclusion criterion
Who may be able to join
- Adults ≥ 18 years old
- confirmed atrial fibrillation on treatment with VKAs or DOACs;
- Signed informed consent;
Who cannot join
- 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 informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
- Keywords
- Atrial Fibrillation (AF), Anticogulant, VKI, DOAC, Major Gastointestinal Bleeding (MGIB)
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start5 Jan 2024
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Società Italiana di Medicina Interna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecilia Becattini, MD, PhD, Principal investigator, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901699
- Sponsor's protocol ID
- RAFTING-GIB
- Acronym
- RAFTING-GIB
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: based on a specific request
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07901699
- Acronym / sponsor ID
- RAFTING-GIB / RAFTING-GIB
- Keywords
- Atrial Fibrillation (AF), Anticogulant, VKI, DOAC, Major Gastointestinal Bleeding (MGIB)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Società Italiana di Medicina InternaUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective multicenter observational study on resumption of anticoagulant therapy after major gastrointestinal bleeding in patients with atrial fibrillation
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients fulfilling inclusion criteria and with no exclusion criterion
Key inclusion criteria (3 listed)
- Adults ≥ 18 years old
- confirmed atrial fibrillation on treatment with VKAs or DOACs;
- Signed informed consent;
Key exclusion criteria (3 listed)
- 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 informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major gastrointestinal bleeding as assessed by the central independent adjudication committee
Time frame: 90 days
Recurrence of Major GIB at 90 days as assessed by the central independent adjudication committee
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes. based on a specific request
Related trials for Atrial Fibrillation (AF)
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilia Becattini, MD, PhD principal investigator
University Of Perugia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Major Gastrointestinal Bleeding (MGIB), run by Società Italiana di Medicina Interna 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 3 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Major gastrointestinal bleeding as assessed by the central independent adjudication committee (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.