CLOPIDOGREL for Non-valvular atrial fibrillation

Inclusion criteria

• {"criterion_text":"- Men or women aged =18 years signing a specific informed consent"}
• {"criterion_text":"- Patients with a planned percutaneous LAA closure"}
• {"criterion_text":"- Patients with documented non-valvular AF, irrespective of the type (paroxysmal, permanent, persistent), and CHA2DS2-VASc score =2"}
• {"criterion_text":"- Patients suitable for treatment with aspirin and clopidogrel according to the Summaries of product characteristics (SmPCs)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patient’s availability to undergo the follow-up visits scheduled for the study"}
• {"criterion_text":"- Negative pregnancy testing (if applicable), performed at the time of enrollment"}

Exclusion criteria

• {"criterion_text":"- CHADS-VAsc score 0-1"}
• {"criterion_text":"- Myocardial infarction or percutaneous coronary intervention <6 months"}
• {"criterion_text":"- Major surgery within one month"}
• {"criterion_text":"- Intracranial neoplasm, aneurysm or arterio-venous malformation"}
• {"criterion_text":"- Platelet count <50,000/µL"}
• {"criterion_text":"- Recent stroke (<1 month)"}
• {"criterion_text":"- Fibrinolytic therapy within 10 days"}
• {"criterion_text":"- Baseline hemoglobin <9 g/dL"}
• {"criterion_text":"- Pregnant woman"}
• {"criterion_text":"- Breast-feeding"}
• {"criterion_text":"- Donne fertili impossibilitate ad utilizzare contraccettivi durante lo studio"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Known hypersensitivity to the study drugs (aspirin or clopidogrel)"}
• {"criterion_text":"- Patients deemed to be unsuitable for at least 6 months antiplatelet therapy (SAPT or DAPT) because of a recent (<1 month) major bleeding event"}
• {"criterion_text":"- Planned oral anticoagulant therapy after the procedure"}
• {"criterion_text":"- Moderate to severe mitral stenosis"}
• {"criterion_text":"- Mechanical heart prosthetic valve"}
• {"criterion_text":"- Active endocarditis"}
• {"criterion_text":"- Active bleeding"}

Primary endpoints

• {"endpoint_text":"- 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 (7).","definition_or_measurement_approach":"Incidence measured at 6 months; DRT assessed by transesophageal echocardiography (TEE) at 3 or 6 months; bleeding graded by BARC classification (≥3); composite includes all-cause death, DRT, ischemic stroke, SEE and BARC ≥3 bleeding."}

Secondary endpoints

• {"endpoint_text":"- DRT at 3 and 6 months by TEE","definition_or_measurement_approach":"Device-related thrombus (DRT) assessed by transesophageal echocardiography (TEE) at 3 and 6 months."}
• {"endpoint_text":"- Any-cause death","definition_or_measurement_approach":"All-cause mortality, assessed through follow-up at specified timepoints."}
• {"endpoint_text":"- Incidence of ischemic stroke or SEE at 3 and 6 months","definition_or_measurement_approach":"Incidence of ischemic stroke or systemic embolic events (SEE) measured at 3 and 6 months."}
• {"endpoint_text":"- Incidence of any bleeding at 3 and 6 months","definition_or_measurement_approach":"All bleeding events recorded and assessed at 3 and 6 months."}
• {"endpoint_text":"- Incidence of BARC classification bleeding ≥3 at 3 and 6 months","definition_or_measurement_approach":"Bleeding events graded by BARC classification; occurrences of BARC ≥3 measured at 3 and 6 months."}

Italy

Earliest CTIS Part Ii Submission Date

05-07-2024

Latest Decision Or Authorization Date

19-12-2025

Processing Time Days

532

Number Of Sites

19

Number Of Participants

606

Primary sponsor

Full Name

Fondazione Toscana Gabriele Monasterio

Organisation Type

Patient organisation/association

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Consorzio Per Valutazioni Biologiche E Farmacologiche","duties_or_roles":"1,12,5,6","organisation_type":"Pharmaceutical company"}