acetylsalicylic acid for Atrial fibrillation

Inclusion criteria

• {"criterion_text":"- 1. Successful percutaneous left atrial appendage occlusion with Amplatzer or WATCHMAN devices within 37 days prior to randomization\n- 2. End-stage renal disease treated with chronic hemodialysis or chronic peritoneal dialysis\n- 3. Age >= 18 yrs\n- 4. Participant is willing to comply with all aspects of the protocol including the assigned treatment strategy and follow-up visits\n- 5. The participant is willing to give written informed consent"}

Exclusion criteria

• {"criterion_text":"- 1. Any indication to chronic antiplatelet therapy other than atrial fibrillation or left atrial appendage occlusion. 2. Indications to chronic anticoagulation 3. Known allergy to clopidogrel of acetylsalicylic acid 4. Diagnosis of coagulation disorders 5. Peridevice leaks greater than 5mm 6. Thrombus in the left atrium on the qualifying imaging of the left atrium 7. Life expectancy less than the duration of the trial due to noncardiovascular comorbidity 8. Enrollment into a competing trial using a non-approved devices or drugs - currently and up to 3 months prior to enrolment 9. Women who are pregnant or breastfeeding and those women of childbearing potential who do not agree to use at least two contraceptive measures (oral contraception, mechanical contraception, approved contraceptive implants, intrauterine device, tubal ligation). The criterion does not apply to women who have been postmenopausal for at least 2 years prior to study enrollment (defined as at least one year without menstrual periods) or underwent surgical sterilization procedure. All eligible women who are younger than 55 years must have negative pregnancy test within 24 hours prior to randomization."}

Primary endpoints

• {"endpoint_text":"- Primary endpoint: comprising major adverse cardiac and cerebrovascular events defined as: 1. efficacy: MACCE - stroke, TIA, peripheral embolism, nonfatal myocardial infarction, cardiovascular and overall mortality; device related thrombosis; and 2. safety: moderate and severe bleedings (type 2-5 BARC).","definition_or_measurement_approach":"Composite primary endpoint defined as MACCE (components: stroke, TIA, peripheral embolism, nonfatal myocardial infarction, cardiovascular and overall mortality; device-related thrombosis) for efficacy, and moderate and severe bleedings classified as type 2-5 BARC for safety."}

Secondary endpoints

• {"endpoint_text":"- individual components of the composite primary end point and: 1. any bleeding 2. new intermediate and large ischemic lesions (≥4mm in size) in central nervous system as assessed by brain MRI 3. new cognitive disorders as assessed by Addenbrooke's Cognitive Examination (ACE-III) 4. thrombosis of the dialysis access; 5. efficacy and safety of LAAC in the periprocedural and 1 month followup","definition_or_measurement_approach":"Secondary endpoints include the individual components of the composite primary endpoint; bleeding events (any bleeding); new intermediate/large ischemic lesions (≥4mm) assessed by brain MRI; new cognitive disorders assessed by Addenbrooke's Cognitive Examination (ACE-III); thrombosis of the dialysis access; and periprocedural and 1-month follow-up efficacy/safety of LAAC (based on registry data)."}

Poland

Earliest CTIS Part Ii Submission Date

30-10-2024

Latest Decision Or Authorization Date

09-12-2024

Processing Time Days

40

Number Of Sites

10

Number Of Participants

80

Primary sponsor

Full Name

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"Soft Communication Danuta Moreń","duties_or_roles":"medical monitoring","organisation_type":"Industry"}