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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Domenico G Della Rocca, MD; Phone Number: 7375296806; Email: domenicodellarocca@hotmail.it
• Study Contact Backup: Name: Andrea Natale, MD; Phone Number: 5127842651; Email: andrea.natale@stdavids.com

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • St. David's Medical Center
      • Contact: Domenico G Della Rocca, MD; Phone Number: 7375296806; Email: domenicodellarocca@hotmail.it
      • Contact: Andrea Natale, MD; Email: Andrea.Natale@stdavids.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Antithrombotic Therapy; OAC for 6 weeks followed by DAPT until 6 month-follow-up, then aspirin alone	Drug: ASA plus Clopidogrel; OAC (6 weeks) + DAPT (until 6 months) + ASA
Active Comparator: 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	Drug: Genetic-Tailored AntiThrombotic Strategy; Half-Dose OAC or Clopidogrel in combination with ASA on the basis of CYP2C19 Genotype
Active Comparator: Half-Dose NOAC; Half Dose of Novel OAC	Drug: Half-Dose of novel OAC; Half Dose of novel OAC post-device Implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite of Stroke, Systemic Embolism, and Device-related Thrombosis	1 year
Incidence of Major Bleeding Events	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Minor Bleeding Events	1 year

Collaborators and Investigators

• Sponsor: Texas Cardiac Arrhythmia Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: left atrial appendage; antithrombotic therapy; Watchman; device-related thrombosis
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Atrial Fibrillation; Thrombosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: TCAI_LAAO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No