Low-dose NOAC Versus GDMT After LAAO

NCT05960721 | Recruiting DMC

• 1 other identifier: RECORD-III
• Study Type: interventional
• Target: 4,220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Left atrial appendage occlusion; Anti-coagulation; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Rate of the composite endpoint of any death, any stroke, systemic embolism, and The Bleeding Academic Research Consortium (BARC)-defined 3 or 5 bleeding events

  24 months post randomization

Secondary Outcomes (19)

• Rate of the composite endpoint of any death, any stroke, systemic embolism, and BARC defined 3 or 5 bleeding events

  45 days, 6, 12 months (Time-to-event)

• Rate of the composite endpoint of any death, any stroke, systemic embolism

  45 days, 6, 12, 24 months (Time-to-event)

• Rate of the BARC type 3 or 5 bleeding events

  45 days, 6, 12, 24 months (Time-to-event)

• Rate of the composite endpoint of any death, any stroke, systemic embolism, myocardial infarction (MI)

  45 days, 6, 12, 24 months (Time-to-event)

• Rate of any death

  45 days, 6, 12, 24 months (Time-to-event)

Study Arms (2)

Low-dose novel oral anti-coagulation (NOAC)-based anti-thrombotic therapy

EXPERIMENTAL

HAS-BLED\<3: Rivaroxaban 15 mg QD for 3 months, followed by Rivaroxaban 10 mg QD indefinitely HAS-BLED≥3: Rivaroxaban 10 mg QD for 3 months, followed by Rivaroxaban 2.5 mg bid indefinitely

Drug: Rivaroxaban 15mg; Drug: Rivaroxaban 10mg; Drug: Rivaroxaban 2.5mg

Guideline determined medication therapy (GDMT)

ACTIVE COMPARATOR

HAS-BLED\<3: Rivaroxaban 15 mg QD + Aspirin 100mg QD for 3 months, then Aspirin 100mg QD indefinitely HAS-BLED≥3: Aspirin 100mg QD + Clopidogrel 75mg QD for 3 months, then Aspirin 100mg QD indefinitely

Drug: Rivaroxaban 15mg; Drug: Aspirin 100mg; Drug: Clopidogrel 75mg

Interventions

Rivaroxaban 15mg DRUG

QD

Guideline determined medication therapy (GDMT); Low-dose novel oral anti-coagulation (NOAC)-based anti-thrombotic therapy

Aspirin 100mg DRUG

QD

Guideline determined medication therapy (GDMT)

Clopidogrel 75mg DRUG

QD

Guideline determined medication therapy (GDMT)

Rivaroxaban 10mg DRUG

QD

Low-dose novel oral anti-coagulation (NOAC)-based anti-thrombotic therapy

Rivaroxaban 2.5mg DRUG

B.I.D

Low-dose novel oral anti-coagulation (NOAC)-based anti-thrombotic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-valvular atrial fibrillation (NVAF) patients with successful left atrial appendage occlusion (LAAO)
• Eligible for guideline-directed anti-thrombotic therapy
• Able to understand and provide informed consent and comply with all study medications

You may not qualify if:

• Under the age of 18
• Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint
• Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
• Concurrent medical condition with a life expectancy of less than two years
• Haemodynamical unstable
• Known contraindication to medications such as heparin, antiplatelet or anticoagulation drugs, or contrast
• Peridevice leak \> 5mm as assessed immediately after LAAO or any other procedure-related complications
• Comorbidities other than atrial fibrillation that required long term use of anticoagulation (such as implanted mechanical valve)
• Percutaneous coronary intervention (PCI) within 1 year.
• The patient had or is planning to have any cardiac or non-cardiac interventional or surgical procedure within 30 days prior to or 60 days after the WATCHMAN device implant (e.g., PCI, cardioversion, cardiac surgery)
• Ongoing overt bleeding
• Previous stroke/TIA within 30 days of enrolment
• Symptomatic carotid artery disease
• Severe renal insufficiency (CrCl≤30ml/min/1.73m2)

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Ling Tao

Xi'an, Shannxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ling Tao, M.D., Ph.D.

  Xijing Hospital

  STUDY CHAIR

• Chao Gao, M.D., Ph.D.

  Xijing Hospital

  STUDY CHAIR

Central Study Contacts

Chao Gao, M.D., Ph.D.

CONTACT

+86-18629551066; woshigaochao@gmail.com

Ruining Zhang, BSc

CONTACT

+86-15802990370; ruining-zhang@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Cardiology, Director of the department of Cardiology

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 27, 2023
• Study Start: July 6, 2023
• Primary Completion: July 30, 2025
• Study Completion (Estimated): July 30, 2028
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)