Recruiting

Anti-Thrombotic Strategies

Sponsor:

Texas Cardiac Arrhythmia Research Foundation

Code:

NCT04502017

Conditions

Device-Related Thrombosis

Atrial Fibrillation

Left Atrial Appendage Occlusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ASA plus Clopidogrel

Genetic-Tailored AntiThrombotic Strategy

Half-Dose of novel OAC

Study Details

Brief summary:

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

Conditions

Device-Related Thrombosis

Atrial Fibrillation

Left Atrial Appendage Occlusion

Study ID

NCT04502017

Start date

Aug 5, 2020

Status verified date

Aug, 2020

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Standard Antithrombotic Therapy

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

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

active comparator: Half-Dose NOAC

Half Dose of Novel OAC

Interventions

ASA plus Clopidogrel

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

Genetic-Tailored AntiThrombotic Strategy

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

Half-Dose of novel OAC

Half Dose of novel OAC post-device Implantation

Primary outcome measure

  • Composite of Stroke, Systemic Embolism, and Device-related Thrombosis [ Time Frame: 1 year ]
  • Incidence of Major Bleeding Events [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Domenico G Della Rocca, MD

7375296806domenicodellarocca@hotmail.it

Andrea Natale, MD

5127842651andrea.natale@stdavids.com

Locations

St. David's Medical Center

Recruiting

Austin, Texas, United States, 78705

Contacts

Andrea Natale, MD

andrea.natale@stdavids.com

Domenico G Della Rocca, MD

7375296806domenicodellarocca@hotmail.it

More Information

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Last update posted

Aug 7, 2020

Last verified

Aug, 2020

Keywords

  • left atrial appendage
  • Watchman
  • antithrombotic therapy
  • device-related thrombosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Cardiac Arrhythmia Research Foundation on 2020-08-07.