Head-to-head Comparison of Single Versus Dual Antiplatelet Treatment Strategy After Percutaneous Left Atrial Appendage Closure: a Multicenter, Randomized Study

NCT05554822 | Unknown Phase 3

• 1 other identifier: 2021-000730-34
• Study Type: interventional
• Target: 574
• Locations: 1 country
• Sites: 19

Brief 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. 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.

Conditions

Left Atrial Appendage Occlusion; Antiplatelet Therapy

Keywords

left atrial appendage; left atrial appendage occlusion; atrial fibrillation; thromboembolic risk

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (5)

• Secondary endpoint: Device-related thrombosis

  At 3 months and at 6 months

• Secondary endpoint: Any-cause death

  6 months

• Secondary endpoint: ischemic stroke or systemic embolic events

  At 3 months and at 6 months

• Secondary endpoint: Any bleeding

  At 3 months and at 6 months

• Secondary endpoint: BARC ≥3 bleeding

  At 3 months and at 6 months

Study Arms (2)

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.

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.

Drug: Aspirin 100 mg OD plus clopidogrel 75 mg OD

Interventions

Aspirin 100mg DRUG

Single antiplatelet therapy with aspirin 100 mg OD for 6 months after the procedure

Single antiplatelet therapy (SAPT)

Aspirin 100 mg OD plus clopidogrel 75 mg OD DRUG

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.

Double antiplatelet therapy (DAPT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• CHADS-VAsc score 0-1
• 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
• 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

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead
• Abbott Medical Devices: collaborator

Study Sites (19)

Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G. Rodolico

Catania, 95123, Italy

RECRUITING

Presidi Ospedalieri Riuniti ASL 6 Ciriè - Presidio Ospedaliero Riunito Sede di Ciriè

Cirié, 10073, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

NOT YET RECRUITING

Centro Cardiologico Fondazione Monzino

Milan, 20138, Italy

NOT YET RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

RECRUITING

Azienda Ospedaliera dei Colli Monaldi

Napoli, 80131, Italy

RECRUITING

Azienda Ospedaliera Universitaria Federico II

Napoli, Italy

NOT YET RECRUITING

Ospedale Maggiore della Carità

Novara, 28100, Italy

RECRUITING

Clinica San Carlo

Paderno Dugnano, 20037, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria di Parma

Parma, 43126, Italy

NOT YET RECRUITING

Policlinico San Matteo

Pavia, 27100, Italy

NOT YET RECRUITING

Ospedale del Cuore G. Pasquinucci

Pisa, 54100, Italy

RECRUITING

Ospedale di Rivoli

Rivoli, 10098, Italy

NOT YET RECRUITING

Ospedale S. Eugenio - ASL Roma 2

Roma, 00144, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Sassari

Sassari, 07100, Italy

RECRUITING

Ospedale Mauriziano Umberto I

Torino, 10128, Italy

NOT YET RECRUITING

Villa Maria Pia Hospital

Torino, 10132, Italy

NOT YET RECRUITING

Ospedale San Giovanni Bosco

Torino, 10154, Italy

NOT YET RECRUITING

Ospedale Sant'Andrea

Vercelli, 13100, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Giuseppe Patti, MD

  University of Eastern Piedmont, Novara - Maggiore della Carità Hospital, Novara

  STUDY DIRECTOR

• Sergio Berti, MD

  Fondazione Toscana G. Monasterio, Ospedale del Cuore "G. Pasquinucci"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Patti, MD

CONTACT

+3903213733597; chiara.ghiglieno@uniupo.it

Chiara Ghiglieno, MD

CONTACT

+3903213733336; chiara.ghiglieno@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director (Co-Chair), MD, Director, Chair of Cardiology, University of Eastern Piedmont, Novara; Director, Department of Thoracic and Cardiovascular Diseases, Maggiore della Carità Hospital, Novara

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 26, 2022
• Study Start: June 14, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

IT (19)