Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-05

Study Completion Date

2023-12-31

Brief Summary

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Comparison among three different antithrombotic strategies after percutaneous LAA occlusion with a Watchman FLX LAAC device.

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Detailed Description

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Data on the optimal antithrombotic therapy (AT) after percutaneous left atrial appendage (LAA) occlusion are still scarce. The classical AT strategy after LAA occlusion includes 6-weeks of warfarin + aspirin followed by dual anti platelet therapy with clopidogrel (75 mg) and aspirin (81-325 mg) until 6 months of follow-up, then aspirin alone is continued indefinitely. Nonetheless, a significant number of patients continues to suffer from device-related thrombosis which carries a high risk of thromboembolic events. Other AT strategies have been tested in order to reduce the risk of thrombus-formation on device. Among them, replacement of clopidogrel with half-dose oral anticoagulation (OAC) in patients with genetic resistance to this drug has been recently reported to reduce the incidence of DRT. Additionally, reduced dose of novel OAC was demonstrated to lead to lower thrombin generation compared to DAPT.

Conditions

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Device-Related Thrombosis Atrial Fibrillation Left Atrial Appendage Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard Antithrombotic Therapy

OAC for 6 weeks followed by DAPT until 6 month-follow-up, then aspirin alone

Group Type ACTIVE_COMPARATOR

ASA plus Clopidogrel

Intervention Type DRUG

OAC (6 weeks) + DAPT (until 6 months) + ASA

Genetic-Tailored AntiThrombotic Strategy

OAC for 6 weeks followed by DAPT (clopidogrel responders) or aspirin plus half-dose OAC (clopidogrel non-responders) until 6 month-follow-up, then aspirin alone

Group Type ACTIVE_COMPARATOR

Genetic-Tailored AntiThrombotic Strategy

Intervention Type DRUG

Half-Dose OAC or Clopidogrel in combination with ASA on the basis of CYP2C19 Genotype

Half-Dose NOAC

Half Dose of Novel OAC

Group Type ACTIVE_COMPARATOR

Half-Dose of novel OAC

Intervention Type DRUG

Half Dose of novel OAC post-device Implantation

Interventions

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ASA plus Clopidogrel

OAC (6 weeks) + DAPT (until 6 months) + ASA

Intervention Type DRUG

Genetic-Tailored AntiThrombotic Strategy

Half-Dose OAC or Clopidogrel in combination with ASA on the basis of CYP2C19 Genotype

Intervention Type DRUG

Half-Dose of novel OAC

Half Dose of novel OAC post-device Implantation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women ≥18 years of age
* Successful LAAC procedure (device implanted without procedural or bleeding complication).
* Patients contraindicated or unsuitable for long-term OAC.
* History of AF (permanent or persistent or paroxysmal).
* Written informed consent by the patient or designee if the patient is unable to consent

Exclusion Criteria

* Life expectancy \< 2 years.
* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No