Optimal antiplatelet treatment after left atrial appendage closure

Phase 1

• Conditions: Atrial fibrillation; MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-001826-16-PL
• Lead Sponsor: arodowy Instytut Kardiologii Stefana kardynala Wyszynskiego- Panstwowy Instytut Badawczy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-04
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1.Successful percutaneous left atrial appendage occlusion with one of the approved devices within 37 days prior to randomization
2.Treatment with dual antiplatelet therapy since the procedure (aspirin and clopidogrel)
3.Age >= 18 yrs
4.Participant is willing to comply with all aspects of the protocol including the assigned treatment strategy and follow-up visits
5.The participant is willing to give written informed consent

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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

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.Peridevice leaks greater than 5mm or thrombus in the left atrium
5. A thrombus in the left atrium
6.Life expectancy less than the duration of the trial due to noncardiovascular comorbidity
7.Enrollment into a competing trial using a non-approved devices or drugs - currently and up to 3 months prior to enrollment
8. Chronic kidney disease stage IV or V

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified