Adverse Reaction to Drugs Affecting the Gastrointestinal SystemPhase 3ELIGIBLENCT01628068
ELIGIBLE (Efficacy of Left atrIal Appendage Closure After GastroIntestinal BLEeding)
A Phase 3 study testing Left atrial appendage occlusion in people with Adverse Reaction to Drugs Affecting the Gastrointestinal System, run by Hospital Clinic of Barcelona at 6 sites in Spain.
Trial summary
Patients with atrial fibrillation requiring anticoagulation treatment are at high risk of gastrointestinal bleeding. The investigators propose the percutaneous stop the oral anticoagulation and closure of the left atrial appendage with the Amplatzer ® system in patients receiving anticoagulant therapy for atrial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Reaction to Drugs Affecting the Gastrointestinal System
- What is being tested?
- Left atrial appendage occlusion
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 6 sitesSpain
- Study dates
- Feb 2012to Jul 2014
- Phase
- Phase 3
- 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
Who may be able to join
- documented atrial fibrilation (paroxysmal or permanent) without significant heart valve disease
- > 18 years
- Classic oral anticoagulation(INR at therapeutic levels: 2-3) or New oral anticoagulants
- CHA2-DS2-VASC score ≥ 3
- prior digestive bleeding without any treatable cause
- Informed consent.
Who cannot join
- POF
- contraindication to further treatment with dual antiplatelet therapy (aspirin + clopidogrel)
- Intracardiac thrombus
- significant carotid disease
- Cardioversion scheduled within 30 days following the implantation
- AF not controlled by FVM> 100 bpm
Show all 11Show fewer
- AF secondary to surgery or ablation
- thrombosis in patients <40 years
- chronic renal insufficiency with Cr clearance <30 ml 2
- left appendage sizeappendage with inlet <12.6 mm or > 28.5 (ETE)
- depth of the appendage <10mm in the TEE
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Hospital Infanta Cristina
Badajoz, Badajoz, 06006
José Ramón López Mínguez, MD, PhD, +34-924218100, lópez-mínguez@hotmail.com
José Ramón López Mínguez, MD, PhD
- Recruiting
Fundació Clínic per a la Recerca Biomèdica
Barcelona, Barcelona, 08036
Victoria Martín Yuste, MD, PhD, +34-932275400, vmartiny@clinic.ub.es
Victoria Martín Yuste, MD, PhD
- Recruiting
Hospital de La Paz
Madrid, Madrid
Raúl Moreno, MD, PhD
Raúl Moreno, MD,PhD
- Recruiting
Hospital Puerta de Hierro
Madrid, Mdrid
Javier Goicolea, MD
Javier Goicolea, MD
- Recruiting
Hospital Virgen de la Victoria
Málaga, Málaga
José María Hernández García, MD
José María Hernández García, MD
- Recruiting
Hospital Virgen de la Macarena
Seville, Sevilla
Rafael Ruiz Salmerón, MD
Rafael Ruiz Salmerón, MD
About this study
Official title: Efficacy of Left Atrial Appendage Closure After Gastrointestinal Bleeding
Patients with atrial fibrillation requiring anticoagulation treatment are at high risk of gastrointestinal bleeding. The investigators propose the percutaneous stop the oral anticoagulation and closure of the left atrial appendage with the Amplatzer ® system in patients receiving anticoagulant therapy for atrial fibrillation without associated valvular heart disease, to reduce significantly the risk of stroke while minimizing the risk of bleeding in a group of patients with high risk for both events.
ELIGIBLE trial(Left atrial appendage Efficacy of GastroIntestinal Bleeding after closure) is a prospective, multicentric and randomized (2 to 1) trial, comparing percutaneous closure of atrial appendage left versus standard treatment with oral anticoagulants in patients with history of gastrointestinal bleeding and high embolic risk.
- Being tested
- Left atrial appendage occlusion
- Keywords
- Left atrial appendage occlusion, gastrointestinal bleeding
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left atrial appendage occlusionDevice
Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months
| Study group | Role | What they receive |
|---|---|---|
| Left atrial appendage occlusion | Active comparator | Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months Receives: Device: Left atrial appendage occlusion |
| Oral anticoagulation | No intervention | Oral anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined overall mortality, major bleeding, stroke or procedure-related complications
The primary end point will be at one year the combined overall mortality, major bleeding, stroke or procedure-related complications.
- Mortality from any cause
- Severe bleeding defined according to VARC criteria
- Ischemic stroke or hemorrhagic stroke at 12 months.
- Complications related to the procedure: include:
- device embolization
- severe pericardial effusion with hemodynamic compromise that requires drainage
- Device thrombosis
- cardiac perforation
- major local complications (according to definitions of VARC)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2013 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Reaction to Drugs Affecting the Gastrointestinal SystemStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Martin Yuste, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628068
- Sponsor's protocol ID
- ELIGIBLE
- Other IDs
- Estudio ELIGIBLE
- Acronym
- ELIGIBLE
- Status last verified
- Jun 2012
- First submitted
- 22 Jun 2012
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Left Atrial Appendage Closure After Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT01628068
- Acronym / sponsor ID
- ELIGIBLE / ELIGIBLE
- Keywords
- Left atrial appendage occlusion, gastrointestinal bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 26 Jun 2012 (estimated)
- 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.
Patients with atrial fibrillation requiring anticoagulation treatment are at high risk of gastrointestinal bleeding. The investigators propose the percutaneous stop the oral anticoagulation and closure of the left atrial appendage with the Amplatzer ® system in patients receiving anticoagulant therapy for atrial fibrillation without associated valvular heart disease, to reduce significantly the risk of stroke while minimizing the risk of bleeding in a group of patients with high risk for both events.
ELIGIBLE trial(Left atrial appendage Efficacy of GastroIntestinal Bleeding after closure) is a prospective, multicentric and randomized (2 to 1) trial, comparing percutaneous closure of atrial appendage left versus standard treatment with oral anticoagulants in patients with history of gastrointestinal bleeding and high embolic risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left atrial appendage occlusion | Active comparator | Device: Left atrial appendage occlusionLeft atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months |
| Oral anticoagulation | No intervention | –Oral anticoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- documented atrial fibrilation (paroxysmal or permanent) without significant heart valve disease
- > 18 years
- Classic oral anticoagulation(INR at therapeutic levels: 2-3) or New oral anticoagulants
- CHA2-DS2-VASC score ≥ 3
- prior digestive bleeding without any treatable cause
Key exclusion criteria (11 listed)
- POF
- contraindication to further treatment with dual antiplatelet therapy (aspirin + clopidogrel)
- Intracardiac thrombus
- significant carotid disease
- Cardioversion scheduled within 30 days following the implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left atrial appendage occlusionLeft atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months | Device | Left atrial appendage occlusion |
Primary outcome
Combined overall mortality, major bleeding, stroke or procedure-related complications
Time frame: 1 year
The primary end point will be at one year the combined overall mortality, major bleeding, stroke or procedure-related complications. 1. Mortality from any cause 2. Severe bleeding defined according to VARC criteria 3. Ischemic stroke or hemorrhagic stroke at 12 months. 4. Complications related to the procedure: include: * device embolization * severe pericardial effusion with hemodynamic compromise that requires drainage * Device thrombosis * cardiac perforation * major local complications (according to definitions of VARC)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Left atrial appendage occlusion in people with Adverse Reaction to Drugs Affecting the Gastrointestinal System, run by Hospital Clinic of Barcelona at 6 sites in Spain.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victoria Martín Yuste, MD, PhD (+34-93-227-55-19, vmartiny@clinic.ub.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined overall mortality, major bleeding, stroke or procedure-related complications (time frame: 1 year). 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 26 Jun 2012.