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

Primary Purpose

Device-Related Thrombosis, Atrial Fibrillation, Left Atrial Appendage Occlusion

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ASA plus Clopidogrel
Genetic-Tailored AntiThrombotic Strategy
Half-Dose of novel OAC
Sponsored by
Texas Cardiac Arrhythmia Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Device-Related Thrombosis focused on measuring left atrial appendage, Watchman, antithrombotic therapy, device-related thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St. David's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Standard Antithrombotic Therapy

Genetic-Tailored AntiThrombotic Strategy

Half-Dose NOAC

Arm Description

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

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 of Novel OAC

Outcomes

Primary Outcome Measures

Composite of Stroke, Systemic Embolism, and Device-related Thrombosis
Incidence of Major Bleeding Events

Secondary Outcome Measures

Incidence of Minor Bleeding Events

Full Information

First Posted
August 4, 2020
Last Updated
August 5, 2020
Sponsor
Texas Cardiac Arrhythmia Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04502017
Brief Title
Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion
Acronym
FADE-DRT
Official Title
Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Cardiac Arrhythmia Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Device-Related Thrombosis, Atrial Fibrillation, Left Atrial Appendage Occlusion
Keywords
left atrial appendage, Watchman, antithrombotic therapy, device-related thrombosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Antithrombotic Therapy
Arm Type
Active Comparator
Arm Description
OAC for 6 weeks followed by DAPT until 6 month-follow-up, then aspirin alone
Arm Title
Genetic-Tailored AntiThrombotic Strategy
Arm Type
Active Comparator
Arm 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
Arm Title
Half-Dose NOAC
Arm Type
Active Comparator
Arm Description
Half Dose of Novel OAC
Intervention Type
Drug
Intervention Name(s)
ASA plus Clopidogrel
Intervention Description
OAC (6 weeks) + DAPT (until 6 months) + ASA
Intervention Type
Drug
Intervention Name(s)
Genetic-Tailored AntiThrombotic Strategy
Intervention Description
Half-Dose OAC or Clopidogrel in combination with ASA on the basis of CYP2C19 Genotype
Intervention Type
Drug
Intervention Name(s)
Half-Dose of novel OAC
Intervention Description
Half Dose of novel OAC post-device Implantation
Primary Outcome Measure Information:
Title
Composite of Stroke, Systemic Embolism, and Device-related Thrombosis
Time Frame
1 year
Title
Incidence of Major Bleeding Events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Incidence of Minor Bleeding Events
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Domenico G Della Rocca, MD
Phone
7375296806
Email
domenicodellarocca@hotmail.it
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Natale, MD
Phone
5127842651
Email
andrea.natale@stdavids.com
Facility Information:
Facility Name
St. David's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Email
andrea.natale@stdavids.com
First Name & Middle Initial & Last Name & Degree
Domenico G Della Rocca, MD
Phone
7375296806
Email
domenicodellarocca@hotmail.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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