Left Atrial Appendage OcclusionPhase 3ARMYDA-AMULETNCT05554822
Head-to-head Comparison of Single Versus Dual Antiplatelet Treatment Strategy After Percutaneous Left Atrial Appendage Closure: a Multicenter, Randomized Study
A Phase 3 study testing Aspirin 100mg and Aspirin 100 mg OD plus clopidogrel 75 mg OD in people with Left Atrial Appendage Occlusion and Antiplatelet Therapy, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 19 sites in Italy.
Trial summary
The study will perform a randomized, head-to-head comparison between SAPT (aspirin) and DAPT (aspirin plus clopidogrel) after percutaneous LAA closure with implantation of the Amulet device (AbbottTM, Abbott Park, Illinois, US) in patients with AF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Atrial Appendage Occlusion, Antiplatelet Therapy
- What is being tested?
- Aspirin 100mg and Aspirin 100 mg OD plus clopidogrel 75 mg OD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 574 participants
- Where
- 19 sitesItaly
- Study dates
- 14 Jun 2021to 31 Dec 2023
- 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
- Men or women aged ≥18 years signing a specific informed consent
- Patients with a planned percutaneous LAA closure;
- Patients with documented non-valvular AF, irrespective of the type (paroxysmal, permanent, persistent), and CHA2DS2-VASc score ≥2
- Patients suitable for treatment with aspirin and clopidogrel according to the Summaries of product characteristics (SmPCs);
- Patients considered unsuitable for long-term oral anticoagulant therapy due to a high bleeding risk. Patients will be judged unsuitable for anticoagulation because of bleeding-prone comorbidities, history of previous bleeding (with or without anticoagulant treatment) or an expected low adherence to therapy.
- Patient's availability to undergo the follow-up visits scheduled for the study
- Negative pregnancy testing (if applicable), performed at the time of enrollment.
Who cannot join
- CHADS-VAsc score 0-1
- Requirement for on-going therapy with clopidogrel at the time of screening evaluation (e.g. current therapy with clopidogrel at the time of the screening evaluation will be an exclusion criterion)
- Known hypersensitivity to the study drugs (aspirin or clopidogrel)
- Patients deemed to be unsuitable for at least 6 months antiplatelet therapy (SAPT or DAPT) because of a recent (<1 month) major bleeding event
- Planned oral anticoagulant therapy after the procedure
- Moderate to severe mitral stenosis
Show all 19Show fewer
- Mechanical heart prosthetic valve
- Active endocarditis
- Active bleeding
- Myocardial infarction or percutaneous coronary intervention <6 months
- Major surgery within one month
- Intracranial neoplasm, aneurysm or arterio-venous malformation
- Platelet count <50,000/μL
- Recent stroke (<1 month)
- Fibrinolytic therapy within 10 days
- Baseline hemoglobin <9 g/dL
- Pregnant woman
- Breast-feeding
- Women unavailable to use contraception during the study period
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Italy19 sites, 19 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G. Rodolico
Catania, 95123
Carmelo Grasso, MD, +390957436420, melfat75@gmail.com
- Not yet recruiting
Presidi Ospedalieri Riuniti ASL 6 Ciriè - Presidio Ospedaliero Riunito Sede di Ciriè
Cirié, 10073
Gaetano Senatore, MD, +3901192171, gsenatore@aslto4.piemonte.it
- Not yet recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Francesco Meucci, MD, +390557949167, francescomeu19@gmail.com
- Not yet recruiting
Centro Cardiologico Fondazione Monzino
Milan, 20138
Claudio Tondo, MD, +3902580021, claudio.tondo@cardiologicomonzino.it
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Jacopo Oreglia, MD, +39 0264442565, jacopoandrea.oreglia@ospedaleniguarda.it
- Recruiting
Azienda Ospedaliera dei Colli Monaldi
Naples, 80131
Paolo Golino, MD, +390817064239, paolo.golino@ospedalideicolli.it
- Not yet recruiting
Azienda Ospedaliera Universitaria Federico II
Naples
Antonio Rapacciuolo, MD
- Recruiting
Ospedale Maggiore della Carità
Novara, 28100
Giuseppe Patti, MD, +3903213975, chiara.ghiglieno@uniupo.it
Chiara Ghiglieno, MD, +3903213733975, chiara.ghiglieno@gmail.com
- Not yet recruiting
Clinica San Carlo
Paderno Dugnano, 20037
Bernardo Cortese, MD, +3902990381, bernardocortese.md@gmail.com
- Not yet recruiting
Azienda Ospedaliero-Universitaria di Parma
Parma, 43126
Luigi Vignali, MD, +390521702070, luvignali@gmail.com
- Not yet recruiting
Policlinico San Matteo
Pavia, 27100
Roberto Rordorf, MD, +390382501276, r.rordorf@smatteo.pv.it
- Recruiting
Ospedale del Cuore G. Pasquinucci
Pisa, 54100
Sergio Berti, MD, +390585483675, berti@ftgm.it
- Not yet recruiting
Ospedale di Rivoli
Rivoli, 10098
Francesco Tomassini, MD, +3901195511
- Not yet recruiting
Ospedale S. Eugenio - ASL Roma 2
Roma, 00144
Achille Gaspardone, MD, +390651002320, a_gaspardone@yahoo.it
- Recruiting
Azienda Ospedaliera Universitaria Sassari
Sassari, 07100
Gavino Casu, MD, +390792061561, gavi.casu@tin.it
- Not yet recruiting
Ospedale Mauriziano Umberto I
Torino, 10128
Stefano Grossi, MD, +390115081111, sgrossi@mauriziano.it
- Not yet recruiting
Villa Maria Pia Hospital
Torino, 10132
Elvis Brscic, MD, +390118967435, brscic@hotmail.com
- Not yet recruiting
Ospedale San Giovanni Bosco
Torino, 10154
Francesco Colombo, MD, +390112402295, giacomoboccuzzi@libero.it
- Not yet recruiting
Ospedale Sant'Andrea
Vercelli, 13100
Fabrizio Ugo, MD, +390161593111
About this study
Official title: Head-to-head Comparison of Single Versus Dual Antiplatelet Treatment Strategy After Percutaneous Left Atrial Appendage Closure: a Multicenter, Randomized Study - ARMYDA-AMULET
The study will perform a randomized, head-to-head comparison between SAPT (aspirin) and DAPT (aspirin plus clopidogrel) after percutaneous LAA closure with implantation of the Amulet device (AbbottTM, Abbott Park, Illinois, US) in patients with AF. Primary outcome measure will be a net composite endpoint at 6 months including all-cause death, DRT, clinically relevant bleeding complications and ischemic events. The SAPT arm will receive aspirin alone up to 6 months, while the DAPT arm will receive DAPT for 3 months and then aspirin alone. Thus, between 3- and 6-month follow-up both groups will be given aspirin alone.
Read the detailed description
State of the art There is no clear evidence on optimal antiplatelet therapy after percutaneous left atrial appendage (LAA) closure in patients with atrial fibrillation (AF). There is a consensus supporting dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel (without oral anticoagulation) after non-WATCHMAN device implantation. However, the use of DAPT after LAA closure was initially derived from other interventional settings (e.g. the antithrombotic approach used after coronary stenting) and available data essentially derive from observational (and often retrospective), non-randomized, studies. Due to the lack of robust and consolidated evidence, the type and duration of antiplatelet therapy after LAA closure are variable and often guided by the individual convincement of the treating physicians. Patients undergoing LAA closure are generally older and have multiple co-morbidities; thus, in these patients the risk of bleeding events is a major concern and antithrombotic therapy may strongly contribute to such risk. Single-center, observational data have suggested that a strategy with single antiplatelet therapy (SAPT, essentially aspirin, without P2Y12 inhibitor) is associated with similar risk of ischemic cerebral events and device-related thrombosis (DRT) and with a significant reduction of bleeding complications after the intervention with 68% reduction in risk of major bleeding (from 7.0% to 2.3%). However, a recent, retrospective evidence raised concerns regarding the effectiveness of SAPT in preventing DRT in this setting of patients. To date, no randomized study has evaluated whether an approach with SAPT, compared to DAPT, is associated with adequate protection from DRT/ischemic events and with decreased bleeding risk. We will address such issue in a randomized, prospective, multicenter study.
Aim of the study The study will perform a randomized, head-to-head comparison between SAPT (aspirin) and DAPT (aspirin plus clopidogrel) after percutaneous LAA closure with implantation of the Amulet device (AbbottTM, Abbott Park, Illinois, US) in patients with AF. Primary outcome measure will be a net composite endpoint at 6 months including all-cause death, DRT, clinically relevant bleeding complications and ischemic events. The SAPT arm will receive aspirin alone up to 6 months, while the DAPT arm will receive DAPT for 3 months and then aspirin alone. Thus, between 3- and 6-month follow-up both groups will be given aspirin alone. We consider that a 6-month follow-up would be more than enough to detect any possible difference between the two groups.
Primary objective:
To demonstrate that SAPT is not inferior to the current standard antiplatelet therapy (DAPT) after LAA closure regarding the cumulative incidence of the net composite endpoint, including death, thrombotic complications and bleeding events, at 6 months.
Secondary objectives:
Compared to DAPT, SAPT use is associated with a similar incidence of ischemic events and a significantly lower incidence of bleeding complications at 6 months.
Study design The study will be phase IV, prospective, multicenter, with 1:1 randomization, open-label, with parallel groups. Consecutive patients with AF undergoing percutaneous LAA closure with the Amulet device will be enrolled. Patients will be included regardless of the type of AF and of clinical indication for LAA closure. Approximately 15 centers with a consolidated experience in the procedure of percutaneous LAA closure will be included. Enrollment will be competitive; each center will include a maximum number of patients corresponding to the 20% of the global population. After the protocol approval, the high-volume centers (e.g. top implanting centers in Italy) will be asked to participate the study, in addition to the Coordinating Center.
- Being tested
- Aspirin 100mg, Aspirin 100 mg OD plus clopidogrel 75 mg OD
- Keywords
- left atrial appendage, left atrial appendage occlusion, atrial fibrillation, thromboembolic risk
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 100mgDrug
Single antiplatelet therapy with aspirin 100 mg OD for 6 months after the procedure
Aspirin 100 mg OD plus clopidogrel 75 mg ODDrug
Double antiplatelet therapy with Aspirin 100 mg OD plus clopidogrel 75 mg OD for 3 months, followed by 3 months of single antiplatelet therapy with aspirin 100 mg OD.
| Study group | Role | What they receive |
|---|---|---|
| Single antiplatelet therapy (SAPT) | Experimental | Single antiplatelet therapy composed of aspirin 100 mg OD, organized as follows:
Aspirin-naïve: aspirin 325 mg will be given 12-24 hours before the procedure and continued after the intervention at the dose of 100 mg OD up to 6-month follow-up.
Aspirin-treated: periprocedural aspirin 100 mg OD will be given and continued up to 6-month followup. Receives: Drug: Aspirin 100mg |
| Double antiplatelet therapy (DAPT) | Active comparator | Double antiplatelet therapy composed of aspirin 100 mg OD plus Clopidogrel 75 mg OD, organized as follows:
Aspirin-naïve: aspirin 325 mg will be given 12-24 hours before the procedure and continued after the intervention at the dose of 100 mg OD up to 6-month follow-up. Clopidogrel will be given with a 300 mg loading dose of clopidogrel approximately 12 hours before the procedure and then clopidogrel 75 mg OD will be given from the day of intervention up to 3 months. At 3 months clopidogrel will be stopped.
Aspirin-treated: periprocedural aspirin 100 mg OD will be given and continued up to 6-month followup. Clopidogrel will be given with a 300 mg loading dose of clopidogrel approximately 12 hours before the procedure and then clopidogrel 75 mg OD will be given from the day of intervention up to 3 months. At 3 months clopidogrel will be stopped. Receives: Drug: Aspirin 100 mg OD plus clopidogrel 75 mg OD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint:all-cause death, DRT (at 3- or 6-month TEE), ischemic stroke, systemic embolic events (SEE) or BARC classification bleeding ≥3.
Primary endpoint will be the 6-month incidence in the two arms (SAPT versus DAPT) of the net composite endpoint including all-cause death, DRT (at 3- or 6-month TEE), ischemic stroke, systemic embolic events (SEE) or BARC classification bleeding ≥3. An independent board for clinical event adjudication and data safety monitoring will be created.
Measured: 6 months
Secondary outcomes (5)
Secondary endpoint: Device-related thrombosis
Device-related thrombosis evaluated with transesophageal echocardiogram
Measured: At 3 months and at 6 months
Secondary endpoint: Any-cause death
Any-cause death
Measured: 6 months
Secondary endpoint: ischemic stroke or systemic embolic events
Incidence of ischemic stroke or systemic embolic events (SEE)
Measured: At 3 months and at 6 months
Secondary endpoint: Any bleeding
Incidence of any bleeding
Measured: At 3 months and at 6 months
Secondary endpoint: BARC ≥3 bleeding
Incidence of BARC classification bleeding ≥3
Measured: At 3 months and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start14 Jun 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Atrial Appendage OcclusionStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- None (open label)
- Enrolment
- 574 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, Giuseppe Patti, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Giuseppe Patti, MD, Study director, University of Eastern Piedmont, Novara - Maggiore della Carità Hospital, NovaraSergio Berti, MD, Principal investigator, Fondazione Toscana G. Monasterio, Ospedale del Cuore "G. Pasquinucci"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554822
- Sponsor's protocol ID
- 2021-000730-34
- Acronym
- ARMYDA-AMULET
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head-to-head Comparison of Single Versus Dual Antiplatelet Treatment Strategy After Percutaneous Left Atrial Appendage Closure: a Multicenter, Randomized Study - ARMYDA-AMULET
- ClinicalTrials.gov ID
- NCT05554822
- Acronym / sponsor ID
- ARMYDA-AMULET / 2021-000730-34
- Keywords
- left atrial appendage, left atrial appendage occlusion, atrial fibrillation, thromboembolic risk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 574 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Sep 2022 (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.
The study will perform a randomized, head-to-head comparison between SAPT (aspirin) and DAPT (aspirin plus clopidogrel) after percutaneous LAA closure with implantation of the Amulet device (AbbottTM, Abbott Park, Illinois, US) in patients with AF. Primary outcome measure will be a net composite endpoint at 6 months including all-cause death, DRT, clinically relevant bleeding complications and ischemic events. The SAPT arm will receive aspirin alone up to 6 months, while the DAPT arm will receive DAPT for 3 months and then aspirin alone. Thus, between 3- and 6-month follow-up both groups will be given aspirin alone.
Detailed description
State of the art There is no clear evidence on optimal antiplatelet therapy after percutaneous left atrial appendage (LAA) closure in patients with atrial fibrillation (AF). There is a consensus supporting dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel (without oral anticoagulation) after non-WATCHMAN device implantation. However, the use of DAPT after LAA closure was initially derived from other interventional settings (e.g. the antithrombotic approach used after coronary stenting) and available data essentially derive from observational (and often retrospective), non-randomized, studies. Due to the lack of robust and consolidated evidence, the type and duration of antiplatelet therapy after LAA closure are variable and often guided by the individual convincement of the treating physicians. Patients undergoing LAA closure are generally older and have multiple co-morbidities; thus, in these patients the risk of bleeding events is a major concern and antithrombotic therapy may strongly contribute to such risk. Single-center, observational data have suggested that a strategy with single antiplatelet therapy (SAPT, essentially aspirin, without P2Y12 inhibitor) is associated with similar risk of ischemic cerebral events and device-related thrombosis (DRT) and with a significant reduction of bleeding complications after the intervention with 68% reduction in risk of major bleeding (from 7.0% to 2.3%). However, a recent, retrospective evidence raised concerns regarding the effectiveness of SAPT in preventing DRT in this setting of patients. To date, no randomized study has evaluated whether an approach with SAPT, compared to DAPT, is associated with adequate protection from DRT/ischemic events and with decreased bleeding risk. We will address such issue in a randomized, prospective, multicenter study.
Aim of the study The study will perform a randomized, head-to-head comparison between SAPT (aspirin) and DAPT (aspirin plus clopidogrel) after percutaneous LAA closure with implantation of the Amulet device (AbbottTM, Abbott Park, Illinois, US) in patients with AF. Primary outcome measure will be a net composite endpoint at 6 months including all-cause death, DRT, clinically relevant bleeding complications and ischemic events. The SAPT arm will receive aspirin alone up to 6 months, while the DAPT arm will receive DAPT for 3 months and then aspirin alone. Thus, between 3- and 6-month follow-up both groups will be given aspirin alone. We consider that a 6-month follow-up would be more than enough to detect any possible difference between the two groups.
Primary objective:
To demonstrate that SAPT is not inferior to the current standard antiplatelet therapy (DAPT) after LAA closure regarding the cumulative incidence of the net composite endpoint, including death, thrombotic complications and bleeding events, at 6 months.
Secondary objectives:
Compared to DAPT, SAPT use is associated with a similar incidence of ischemic events and a significantly lower incidence of bleeding complications at 6 months.
Study design The study will be phase IV, prospective, multicenter, with 1:1 randomization, open-label, with parallel groups. Consecutive patients with AF undergoing percutaneous LAA closure with the Amulet device will be enrolled. Patients will be included regardless of the type of AF and of clinical indication for LAA closure. Approximately 15 centers with a consolidated experience in the procedure of percutaneous LAA closure will be included. Enrollment will be competitive; each center will include a maximum number of patients corresponding to the 20% of the global population. After the protocol approval, the high-volume centers (e.g. top implanting centers in Italy) will be asked to participate the study, in addition to the Coordinating Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Single antiplatelet therapy (SAPT) | Experimental | Drug: Aspirin 100mgSingle antiplatelet therapy composed of aspirin 100 mg OD, organized as follows: Aspirin-naïve: aspirin 325 mg will be given 12-24 hours before the procedure and continued after the intervention at the dose of 100 mg OD up to 6-month follow-up. Aspirin-treated: periprocedural aspirin 100 mg OD will be given and continued up to 6-month followup. |
| Double antiplatelet therapy (DAPT) | Active comparator | Drug: Aspirin 100 mg OD plus clopidogrel 75 mg ODDouble antiplatelet therapy composed of aspirin 100 mg OD plus Clopidogrel 75 mg OD, organized as follows: Aspirin-naïve: aspirin 325 mg will be given 12-24 hours before the procedure and continued after the intervention at the dose of 100 mg OD up to 6-month follow-up. Clopidogrel will be given with a 300 mg loading dose of clopidogrel approximately 12 hours before the procedure and then clopidogrel 75 mg OD will be given from the day of intervention up to 3 months. At 3 months clopidogrel will be stopped. Aspirin-treated: periprocedural aspirin 100 mg OD will be given and continued up to 6-month followup. Clopidogrel will be given with a 300 mg loading dose of clopidogrel approximately 12 hours before the procedure and then clopidogrel 75 mg OD will be given from the day of intervention up to 3 months. At 3 months clopidogrel will be stopped. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women aged ≥18 years signing a specific informed consent
- Patients with a planned percutaneous LAA closure;
- Patients with documented non-valvular AF, irrespective of the type (paroxysmal, permanent, persistent), and CHA2DS2-VASc score ≥2
- Patients suitable for treatment with aspirin and clopidogrel according to the Summaries of product characteristics (SmPCs);
- Patients considered unsuitable for long-term oral anticoagulant therapy due to a high bleeding risk. Patients will be judged unsuitable for anticoagulation because of bleeding-prone comorbidities, history of previous bleeding (with or without anticoagulant treatment) or an expected low adherence to therapy.
Key exclusion criteria (19 listed)
- CHADS-VAsc score 0-1
- Requirement for on-going therapy with clopidogrel at the time of screening evaluation (e.g. current therapy with clopidogrel at the time of the screening evaluation will be an exclusion criterion)
- Known hypersensitivity to the study drugs (aspirin or clopidogrel)
- Patients deemed to be unsuitable for at least 6 months antiplatelet therapy (SAPT or DAPT) because of a recent (<1 month) major bleeding event
- Planned oral anticoagulant therapy after the procedure
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 |
|---|---|---|
| Aspirin 100mgSingle antiplatelet therapy with aspirin 100 mg OD for 6 months after the procedure | Drug | Single antiplatelet therapy (SAPT) |
| Aspirin 100 mg OD plus clopidogrel 75 mg ODDouble antiplatelet therapy with Aspirin 100 mg OD plus clopidogrel 75 mg OD for 3 months, followed by 3 months of single antiplatelet therapy with aspirin 100 mg OD. | Drug | Double antiplatelet therapy (DAPT) |
Primary outcome
Primary endpoint:all-cause death, DRT (at 3- or 6-month TEE), ischemic stroke, systemic embolic events (SEE) or BARC classification bleeding ≥3.
Time frame: 6 months
Primary endpoint will be the 6-month incidence in the two arms (SAPT versus DAPT) of the net composite endpoint including all-cause death, DRT (at 3- or 6-month TEE), ischemic stroke, systemic embolic events (SEE) or BARC classification bleeding ≥3. An independent board for clinical event adjudication and data safety monitoring will be created.
5 secondary outcomes
Secondary endpoint: Device-related thrombosis
Time frame: At 3 months and at 6 months
Secondary endpoint: Any-cause death
Time frame: 6 months
Secondary endpoint: ischemic stroke or systemic embolic events
Time frame: At 3 months and at 6 months
Secondary endpoint: Any bleeding
Time frame: At 3 months and at 6 months
Secondary endpoint: BARC ≥3 bleeding
Time frame: At 3 months and at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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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.
Giuseppe Patti, MD study director
University of Eastern Piedmont, Novara - Maggiore della Carità Hospital, Novara
Sergio Berti, MD principal investigator
Fondazione Toscana G. Monasterio, Ospedale del Cuore "G. Pasquinucci"
19 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 Aspirin 100mg and Aspirin 100 mg OD plus clopidogrel 75 mg OD in people with Left Atrial Appendage Occlusion and Antiplatelet Therapy, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 19 sites 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 7 inclusion and 19 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 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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.
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 Giuseppe Patti, MD (+3903213733597, chiara.ghiglieno@uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint:all-cause death, DRT (at 3- or 6-month TEE), ischemic stroke, systemic embolic events (SEE) or BARC classification bleeding ≥3. (time frame: 6 months). 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 3 Oct 2022.