RecruitingNot ApplicableNCT05960721

Low-dose NOAC Versus GDMT After LAAO

Low-dose Rivaroxaban Monotherapy Versus Guideline Determined Medication Therapy After Left Atrial Appendage Occlusion: a Randomized, Open-label, Multicentre, Superiority Trial


Sponsor

Xijing Hospital

Enrollment

4,220 participants

Start Date

Jul 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The increased risk of Atrial fibrillation (AF) regarding thromboembolic stroke is predominantly due to the formation and embolization of clots from within the left atrial appendage (LAA). Percutaneous left atrial appendage occlusion (LAAO) is a nonpharmacological strategy for stroke prevention in patients with AF. Data from randomized trials, including PROTECT-AF, PREVAIL, and Prague-17, have suggested that LAAO has comparable efficacy to warfarin or NOACs. Considering these results, LAAO was recommended by the American College of Cardiology (ACC) and European Society of Cardiology (ESC) guidelines as a non-pharmacological stroke prevention strategy for patients with NVAF who have contraindications or are unsuitable for OAC. The PROTECT-AF and PREVAIL trials stipulated the use of standardized antithrombotic medications which were designed to minimize the risk of stroke, systemic embolism, or device-related thrombosis. This antithrombotic strategy was subsequently endorsed by the guidelines, briefly, patients with LAAO were discharged on warfarin and aspirin for 45 days post-LAAO, if there was no leak or a leak ≤5 mm under transesophageal echocardiography (TEE) at 45-day follow-up, antithrombotic strategies shall switch to dual antiplatelet therapy (DAPT) until 6 months post-LAAO, and then aspirin thereafter. Although LAAO was recommended by medical societies, previous patient-level meta-analyses have implied that compared with oral anticoagulation, LAAO had significantly more ischemic strokes, suggesting the inability of LAAO to prevent an ischemic stroke from sources beyond LAA. Will a combined strategy of LAAO and OAC further reduce the risk of stroke? The investigators hypothesized that a long-term low dose-Rivaroxaban (10mg daily) post-LAAO might be a potent supplement to the residue risk of ischemic stroke.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial studies whether a lower dose of blood thinner medication is safe and effective after a left atrial appendage occlusion (LAAO) procedure in people with atrial fibrillation. **You may be eligible if...** - You have non-valvular atrial fibrillation and have had a successful LAAO procedure - You are eligible for standard anti-clotting therapy - You are at least 18 years old and can provide informed consent **You may NOT be eligible if...** - You are pregnant or nursing - You have a life expectancy of less than two years - You have unstable heart function - You have a known allergy or contraindication to blood thinners - You had a stroke or TIA in the past 30 days - You have a large leak around the device (more than 5mm) or other serious procedure complications - You need long-term anticoagulation for another reason (like a mechanical heart valve) - You recently had or are planning a cardiac procedure within specific timeframes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRivaroxaban 15mg

QD

DRUGAspirin 100mg

QD

DRUGClopidogrel 75mg

QD

DRUGRivaroxaban 10mg

QD

DRUGRivaroxaban 2.5mg

B.I.D


Locations(1)

Ling Tao

Xi'an, Shannxi, China

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NCT05960721


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