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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
• Collaborator: Abbott Medical Devices
• Treatments: Aspirin; Clopidogrel

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• 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