Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure

NCT03568890 · tracked via the Priya Life Science Canada tracker

Sponsor

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Phase

Phase 4

Started

2018-09-01

Last updated

2026-03-27

Condition(s) studied

Left Atrial Appendage ClosureThrombosisStrokeTIABleeding

Investigational drug(s) / intervention(s)

Rivaroxaban, dabigatran, apixaban, or edoxaban →Clopidogrel -75 mg/day →Low dose aspirin -80 to 125 mg/day-

Rivaroxaban, dabigatran, apixaban, or edoxaban: Duration of treatment: 60 days

Clopidogrel -75 mg/day: Duration of treatment: 60 days

Low dose aspirin -80 to 125 mg/day-: Duration of treatment: 60 days

Study summary

The objective of the study is to compare short-term (8 weeks) anticoagulation therapy (DOAC) vs. antiplatelet therapy for the prevention of device thrombosis following transcatheter LAAC.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: * Successful transcatheter LAAC with any approved device * Age≥18 years old 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 requiring dual antiplatelet therapy * Prior intracranial hemorrhage * Contraindications for TEE * Severe pericardial effusion within the first 24 hrs following LAAC * Major/life-threatening bleeding event within the month prior to LAAC * Multiple bleeding events (minor or major) within the month prior to LAAC * Major/life-threatening bleeding within the first 24 hrs following LAAC

Primary outcome measure(s)

Device thrombosis (efficacy outcome) — 60 days after LAAC
Evaluated by TEE
Combined outcome of all-cause mortality, bleeding, stroke, or Device thrombosis (Safety outcome) — 60 days after LAAC
Clinically evaluated and diagnosed by the center investigators and determining a treatment change.

Trial sites (1)

Facility	City	Region	Status
Josep Rodes-Cabau	Québec	Quebec

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03568890 on ClinicalTrials.gov ↗ ← All trials in Canada