Patients with atrial fibrillation undergoing percutaneous left atrial appendage closure with the Amulet device MedDRA version: 20.0 Level: LLT Classification code 10016566 Term: Fibrillation atrial System Organ Class: 100000004849
Conditions
Interventions
Product Name: clopidogrel 75
Product Code: [NA]
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CLOPIDOGREL
CAS Number: 113665-84-2
Current Sponsor code: NA
Concentration unit: mg milligr
Sponsors
FONDAZIONE TOSCANA GABRIELE MONASTERIO
Eligibility
Sex/Gender
All
Inclusion 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 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 115 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 459
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the strategy with single antiplatelet therapy (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 Objective: 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.;Primary end point(s): Primary endpoint will be the 6-month incidence in the two arms (SAPT versus DAPT) of the net composite endpoint including all-cause death, device-related thrombosis (DRT) (at 3- or 6-month transesophageal echocardiography (TEE)), ischemic stroke, systemic embolic events (SEE) or BARC classification bleeding =3 (7). An independent board for clinical event adjudication and data safety monitoring will be created.;Timepoint(s) of evaluation of this end point: 6-month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following secondary endpoints will be separately considered and compared in the two arms: -DRT at 3 and 6 months by TEE -Any-cause death -Incidence of ischemic stroke or SEE at 3 and 6 months -Incidence of any bleeding at 3 and 6 months -Incidence of BARC classification bleeding =3 at 3 and 6 months;Timepoint(s) of evaluation of this end point: Timepoint(s) of evaluation varies depending on the end point. Please refers to section E.5.2.EN for more details. | — |
Countries
Italy
Contacts
Public ContactServizio Regolatorio
Consorzio per Valutazioni Biologiche e Farmacologiche
Outcome results
None listed