Optimal antiplatelet treatment after left atrial appendage closure in chronickidney disease patients

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: EUCTR2021-006127-17-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: 2022-03-14
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Successful percutaneous left atrial appendage occlusion with
Amplatzer or WATCHMAN devices within 37 days prior to randomization
2. End-stage renal disease treated with chronic hemodialysis or chronic peritoneal dialysis
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

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. 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.

Study & Design

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