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

Phase 4

• Conditions: Device-Related Thrombosis; Left Atrial Appendage Occlusion; Atrial Fibrillation
• Interventions: Drug: Genetic-Tailored AntiThrombotic Strategy; Drug: Half-Dose of novel OAC; Drug: ASA plus Clopidogrel

• Registration Number: NCT04502017
• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-04
• Study Start: 2020-08-05
• Last Update Submitted: 2020-08-05
• Study First Posted: 2020-08-06
• Last Update Posted: 2020-08-07
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genetic-Tailored AntiThrombotic Strategy	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
Half-Dose NOAC	Half-Dose of novel OAC	Half Dose of Novel OAC
Standard Antithrombotic Therapy	ASA plus Clopidogrel	OAC for 6 weeks followed by DAPT until 6 month-follow-up, then aspirin alone

Primary Outcome Measures

Name	Time	Method
Composite of Stroke, Systemic Embolism, and Device-related Thrombosis	1 year
Incidence of Major Bleeding Events	1 year

Secondary Outcome Measures

Name	Time	Method
Incidence of Minor Bleeding Events	1 year

Trial Locations

Locations (1)

St. David's Medical Center; 🇺🇸 Austin, Texas, United States