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NCT Number: NCT05960721

Low-dose NOAC Versus GDMT After LAAO

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Rivaroxaban 15mg

Drug

QD

Aspirin 100mg

Drug

QD

Clopidogrel 75mg

Drug

QD

Rivaroxaban 10mg

Drug

QD

Rivaroxaban 2.5mg

Drug

B.I.D

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

    Time frame: 24 months post randomization

Secondary outcomes

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

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

  2. Rate of the composite endpoint of any death, any stroke, systemic embolism

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

  3. Rate of the BARC type 3 or 5 bleeding events

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

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

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

  5. Rate of any death

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

  6. Rate of any stroke

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

  7. Rate of systemic embolism

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

  8. Rate of myocardial infarction (MI)

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

  9. Rate of BARC type 2, 3 or 5 bleeding events

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

  10. Rate of BARC type 2 bleeding events

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

  11. Rate of BARC type 3 bleeding events

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

  12. Rate of BARC type 5 bleeding events

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

  13. Rate of GUSTO defined major bleeding and/or minor bleeding

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

    Global Use of Strategies to Open Occluded Arteries, (GUSTO) defined major bleeding and/or minor bleeding

  14. Rate of TIMI defined major bleeding and/or minor bleeding

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

    Thrombolysis in Myocardial Infarction (TIMI) defined major bleeding and/or minor bleeding

  15. Rate of ISTH defined major bleeding and/or clinically relevant minor bleeding

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

    International Society on Thrombosis and Haemostasis (ISTH) defined major bleeding and/or clinically relevant minor bleeding

  16. Rate of patient adherence to allocated medication

    Time frame: 45 days, 6, 12, 24 months (Binary)

    Adherence is defined as the participant who uses the medication strategies in this trial achieving 80% of the time on the therapeutic range

  17. Scores of the National Institutes of Health Stroke Scale (NIHSS) questionnaire

    Time frame: 45 days, 6, 12, 24 months (Continuous)

    The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.

    The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

  18. Scores of the Modified Rankin Scale (mRS)

    Time frame: 45 days, 6, 12, 24 months (Continuous)

    The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials.

  19. Scores of the 5-level EQ-5D version (EQ-5D-5L) questionnaire

    Time frame: 45 days, 6, 12, 24 months (Continuous)

    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+86-18629551066

Ruining Zhang, BSc

CONTACT

[email protected]

+86-15802990370

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Acronym: RECORD-III

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Jul 27, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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