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

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05671276

Collaborator

Second Affiliated Hospital of Nantong University (Other), Jiangsu Taizhou People's Hospital (Other)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Left Atrial Appendage Occlusion Silent Cerebral Embolism	Drug: aspirin and clopidogrel Drug: Rivaroxaban	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of silent cerebral embolism (SCE) detected by MRI [45 days to 12 months]
New SCE at any MRI during the follow-up

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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