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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05671276
• Other study ID #: 2022-SR-228
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Kexin Wang, MD
• Phone: 18018223427
• Email: 840507356[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolism
• Intracranial Embolism
• Left Atrial Appendage Occlusion

Intervention

Drug:
• aspirin and clopidogrel
DAPT (until 6 months) + ASA
• Rivaroxaban
half-dose NOAC

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University	Jiangsu Taizhou People's Hospital, Second Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of silent cerebral embolism (SCE) detected by MRI	New SCE at any MRI during the follow-up	45 days to 12 months
Secondary	More than two new SCE detected by MRI	More than two new SCE at any MRI during the follow-up, describing the number, location and the size.	45 days to 12 months
Secondary	Cognition function detected by MMSE test	Cognition score detected by MMSE test	45 days to 12 months
Secondary	MoCA test	Cognition score detected by MoCA test	45 days to 12 months
Secondary	Composite endpoint of of all-cause mortality, clinical thromboembolic events and major bleeding events	Clinical thromboembolic including Ischemic stroke, Peripheral thromboembolic event, et al. Major bleeding including intracrania bleeding, gastrointestina bleeding et al.	45 days to 12 months