Short-term blood-thinning medication versus antiplatelet therapy for the prevention of blood clots following left atrial appendage closure.

Phase 1

• Conditions: Device thrombosis at 2 months and 12 months after left atrial appendage closure (LAAC) Ischemic events (stroke, TIA) at 2-month and 1-, 2-, 3-, 4-and 5-year follow-up Bleeding events at 2-month and 1-, 2-, 3-, 4-and 5-year follow-up; MedDRA version: 20.0 Level: HLGT Classification code 10014523 Term: Embolism and thrombosis System Organ Class: 10047065 - Vascular disorders; MedDRA version: 20.0 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0 Level: LLT Classification code 10005103 Term: Bleeding System Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-003621-28-ES
• Lead Sponsor: IUCPQ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-12
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 350

Inclusion Criteria

-Successful transcatheter LAAC with any approved device
-Age=18 years old
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 290

Exclusion Criteria

-Absolute contraindications for anticoagulation therapy
-Absolute contraindications for antiplatelet therapy
-End-stage renal disease (CrCl <15 ml/min)
-Recent percutaneous revascularization with drug-eluting stents necessitating dual antiplatelet therapy
-Prior intracranial hemorrhage
-Contraindications for TEE
-Severe pericardial effusion within the first 24 hrs following LAAC
-Major/life-threatening bleeding within the first 24 hrs following LAAC

Study & Design

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