Efficacy of Different Anti-Thrombotic Strategies on the Incidence of

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05671276
Study type	Interventional
Source	The First Affiliated Hospital with Nanjing Medical University
Contact	Kexin Wang, MD
Phone	18018223427
Email	840507356@qq.com
Status	Recruiting
Phase	Phase 4
Start date	February 1, 2022
Completion date	September 1, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms