Efficacy of Different Anti-Thrombotic Strategies on the Incidence of Silent Cerebral Embolism After Percutaneous Left Atrial Appendage Occlusion

January 3, 2023 updated by: The First Affiliated Hospital with Nanjing Medical University

Efficacy of Different Anti-Thrombotic Strategies on the Incidence of Silent Cerebral Embolism After Percutaneous Left Atrial Appendage Occlusion: a Randomized Control Trial

The primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of silent cerebral embolism.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND Left atrial appendage intervention is increasingly recognized as an alternative strategy for thromboembolism prophylaxis in AF. Theoretically, a complete occlusion of left atrial appendage may eliminate the possibility of embolism from the appendage. However, residual risk exists due to blood stasis and endothelial dysfunction in the atrial fibrillation state. This may raise an issue that whether we should and how to give the patients after appendage occlusion long-term antithrombotic therapy.

Meanwhile, patients with AF have a high incidence of silent cerebral embolism (SCE), which has similar impact with clinical stroke on cognition function. We hypothesized that the SCE caused by micro embolism may act as part of the residual risk after appendage occlusion, thus, an optimal antithrombotic treatment to decrease the incidence of SCE remains unclear.

AIM OF THIS STUDY The primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of SCE. The primary endpoint is incidence of SCE detected by MRI. The secondary endpoints are more than two new SCE detected by MRI, cognition function and composite endpoint of all-cause mortality, clinical thromboembolic events and major bleeding events.

DESIGN This is a randomized, prospective, multicenter design. We aim to include 150 patients 45 days after successful LAAC with WATCHMAN device. Patients are randomized in a 1:1 fashion into two arms: Standard Antiplatelet Therapy and Half-Dose NOAC. Follow-up duration of this study is 12 months. The 1-year routine follow-up strategy included DW-MRI scans performed approximately 90 days, 180 days, and 365 days post-procedure.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  1. AF patients over 18 years old
  2. Patients had undergone left atrial appendage occlusion with WATCHMAN device and confirmed no significant peri-device leak or DRT at the 45-day CT
  3. Patients have a history of ischemic thromboembolic events or have CHA2DS2-VASc score ≥3

Exclusion Criteria:

  1. Patients with an indication of long-term antiplatelet therapy other than LAAO at the time of enrollment (eg, ACS, Intracranial vascular stenosis≥75%)
  2. Absolute contraindications to OAC
  3. Absolute contraindications to anti-platelet therapy
  4. Contraindications to MR or unwilling to receiving MR
  5. Patients with clinical thromboembolicor major bleeding events within 45 days after LAA occlusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Antiplatelet Therapy
DAPT (aspirin 100 mg and clopidogrel 75 mg) from 45 days to 6 month-follow-up, then aspirin alone
Drug: aspirin and clopidogrel
DAPT (until 6 months) + ASA
Experimental: Half-Dose NOAC
Long-term half-dose NOAC (rivaroxaban 10 mg after 45 days)
Drug: Rivaroxaban
half-dose NOAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of silent cerebral embolism (SCE) detected by MRI
Time Frame: 45 days to 12 months
New SCE at any MRI during the follow-up
45 days to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
More than two new SCE detected by MRI
Time Frame: 45 days to 12 months
More than two new SCE at any MRI during the follow-up, describing the number, location and the size.
45 days to 12 months
Cognition function detected by MMSE test
Time Frame: 45 days to 12 months
Cognition score detected by MMSE test
45 days to 12 months
MoCA test
Time Frame: 45 days to 12 months
Cognition score detected by MoCA test
45 days to 12 months
Composite endpoint of of all-cause mortality, clinical thromboembolic events and major bleeding events
Time Frame: 45 days to 12 months
Clinical thromboembolic including Ischemic stroke, Peripheral thromboembolic event, et al. Major bleeding including intracrania bleeding, gastrointestina bleeding et al.
45 days to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborators

Second Affiliated Hospital of Nantong University
Jiangsu Taizhou People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-SR-228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on aspirin and clopidogrel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe