NCT05671276

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

2.6 years

First QC Date

January 3, 2023

Last Update Submit

January 3, 2023

Conditions

Atrial FibrillationLeft Atrial Appendage OcclusionSilent Cerebral Embolism

Keywords

Atrial FibrillationLeft Atrial Appendage OcclusionSilent Cerebral EmbolismOral AnticoagulationAntiplatelet Therapy

Outcome Measures

Primary Outcomes (1)

  • Incidence of silent cerebral embolism (SCE) detected by MRI

    New SCE at any MRI during the follow-up

    45 days to 12 months

Secondary Outcomes (4)

  • More than two new SCE detected by MRI

    45 days to 12 months

  • Cognition function detected by MMSE test

    45 days to 12 months

  • MoCA test

    45 days to 12 months

  • Composite endpoint of of all-cause mortality, clinical thromboembolic events and major bleeding events

    45 days to 12 months

Study Arms (2)

Standard Antiplatelet Therapy

ACTIVE COMPARATOR

DAPT (aspirin 100 mg and clopidogrel 75 mg) from 45 days to 6 month-follow-up, then aspirin alone

Drug: aspirin and clopidogrel

Half-Dose NOAC

EXPERIMENTAL

Long-term half-dose NOAC (rivaroxaban 10 mg after 45 days)

Drug: Rivaroxaban

Interventions

aspirin and clopidogrelDRUG

DAPT (until 6 months) + ASA

Standard Antiplatelet Therapy
RivaroxabanDRUG

half-dose NOAC

Half-Dose NOAC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

AspirinClopidogrelRivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingMorpholinesOxazines

Central Study Contacts

Kexin Wang, MD

CONTACT

18018223427840507356@qq.com

Weizhu Ju, MD

CONTACT

15358162522juweizhu@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 4, 2023

Study Start

February 1, 2022

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

January 4, 2023

Record last verified: 2023-01

Locations

CN(1)