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Antithrombotic Strategies After LAAO
NCT05671276Phase 4
Key facts
- Status
- Unknown
- Start
- Feb 2022
- Primary completion
- Sep 2024
- Countries
- 1
- Sponsor
- Jiangsu Provincial People's Hospital
- Modality
- Small Molecules
- Drugs
- rivaroxaban
- Conditions
- Atrial fibrillation (AFib)
01
Overview
Phase 4, randomised, open-label trial of rivaroxaban in Atrial fibrillation (AFib) (2 arms), sponsored by Jiangsu Provincial People's Hospital. Primary endpoint: Incidence of silent cerebral embolism detected by MRI. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Half-Dose NOAC
Rivaroxaban 10 mg daily
Standard Antiplatelet Therapy
DAPT (Aspirin 100mg + Clopidogrel 75mg) until 6 months, then Aspirin alone
03
Who it enrols
Patients with AF over 18 years old who have undergone successful LAAO with WATCHMAN device (no leak/DRT at 45 days) and have high stroke risk (CHA2DS2-VASc >=3 or history of event). Excludes those with other indications for long-term antiplatelet therapy or contraindications to MRI/drugs.
04
Endpoints
Primary
Incidence of silent cerebral embolism detected by MRI
Secondary
More than two new SCE detected by MRI
Cognition function detected by MMSE test
MoCA test
Composite endpoint of all-cause mortality, clinical thromboembolic events and major bleeding events
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