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

Texas Cardiac Arrhythmia Research Foundation

Status and phase: Unknown; Phase 4

Conditions: Left Atrial Appendage Occlusion; Atrial Fibrillation; Device-Related Thrombosis

Treatments: Drug: Half-Dose of novel OAC; Drug: Genetic-Tailored AntiThrombotic Strategy; Drug: ASA plus Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT04502017

TCAI_LAAO

Details and patient eligibility

About

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

Full description

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 3 patient groups

Standard Antithrombotic Therapy

Active Comparator group

Description:

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

Treatment:

Drug: ASA plus Clopidogrel

Genetic-Tailored AntiThrombotic Strategy

Active Comparator group

Description:

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

Treatment:

Drug: Genetic-Tailored AntiThrombotic Strategy

Half-Dose NOAC

Active Comparator group

Description:

Half Dose of Novel OAC

Treatment:

Drug: Half-Dose of novel OAC