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Aspirin Discontinuation After Left Atrial Appendage Occlusion in Atrial Fibrillation (ASPIRIN-LAAO)

9 oktober 2021 bijgewerkt door: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

The ASPIRIN LAAO trial is a prospective, multi-center, randomized, double blinded, placebo-controlled study aiming at investigating the safety of terminating the use of aspirin after left atrial appendage occlusion (LAAO).

Patients diagnosed with atrial fibrillation and have undergone LAAO will be enrolled in this study. Randomization will be performed at 6 months post-implant. The randomization program electronically assigns the patient 1:1 to either the Aspirin group or the control group. Study patients assigned to Aspirin group will receive enteric coated aspirin (100 mg/day). The control group receives placebo. After the randomization, subjects of both groups will have follow-up visits at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment. For each group, 560 patients will be included, with an estimated total number of 1120 participants in this clinical study. Patients will be followed up until 24 months after the last enrollment.

The primary endpoint is a composite consisting of stroke, systemic embolism, cardiovascular or unexplainable death, acute coronary syndrome, coronary artery disease or periphery vascular disease requiring revascularization and major bleeding. The secondary endpoints are all-cause death, device related thrombus, minor bleeding and rehospitalization due to heart failure.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The ASPIRIN LAAO trial is a prospective, multi-center, randomized, double blinded, placebo-controlled study aiming at investigating the safety of terminating the use of aspirin since the sixth month after LAAO.

Patients diagnosed with paroxysmal or persistent atrial fibrillation with an age between 18 and 90 years and have undergone LAAO will be enrolled in this study. Randomization will be performed at 6 months post-implant. The randomization program electronically assigns the patient 1:1 to either the Aspirin group or the control group. Study patients assigned to Aspirin group will receive enteric coated aspirin (100 mg/day). The control group receives placebo. After the randomization, subjects of both groups will have follow-up visits at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment. For each group, 560 patients will be included, with an estimated total number of 1120 participants in this clinical study. Patients will be followed up until 24 months after the last enrollment.

The primary endpoint is a composite consisting of stroke, systemic embolism, cardiovascular or unexplainable death, acute coronary syndrome, coronary artery disease or periphery vascular disease requiring revascularization and major bleeding. The secondary endpoints are all-cause death, device related thrombus, minor bleeding and rehospitalization due to heart failure.

Studietype

Ingrijpend

Inschrijving (Verwacht)

1120

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Werving
        • Xinhua Hospital, School of Medicne, Shanghai Jiao Tong University
        • Contact:
        • Hoofdonderzoeker:
          • Yi-Gang Li, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 90 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Age between 18 and 90 years
  • Paroxysmal, persistent, long-standing persistent or permanent nonvalvular AF
  • Have already had a Watchman LAAO device implanted 6 months ago

Exclusion Criteria:

Clinical Exclusion Criteria

  • Long-term aspirin therapy required
  • Including coronary artery disease, symptomatic carotid disease, prior myocardial infarction, strokes or systemic embolism, etc
  • Contraindicated for aspirin therapy
  • Including active peptic ulcer, thrombocytopenia or anemia, etc.
  • Uncontrolled malignant tumor
  • Abnormal liver, renal or coagulation function
  • Pregnant or pregnancy is planned during the course of the investigation
  • Terminal illness with life expectancy <1 year
  • Enrolled in another IDE or IND investigation of a cardiovascular device or an investigational drug

TEE Exclusion Criteria*

  • Peri-device leak >5mm
  • Device-related thrombus
  • Other intracardiac thrombus

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Aspirin group
Study patients assigned to Aspirin group will receive enteric coated aspirin (100 mg/day).
Geneesmiddel: Aspirin Tablet
Aspirin 100mg qd
Placebo-vergelijker: Control group
Study patients assigned to control group will receive placebo.
Geneesmiddel: Placebo
Placebo qd

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants with stroke
Tijdsspanne: 24 months after the date of randomization.
A stroke is a medical condition in which poor blood flow to the brain results in cell death. There are two main types of stroke: ischemic, due to lack of blood flow, and hemorrhagic, due to bleeding. They result in part of the brain not functioning properly. Signs and symptoms of a stroke may include an inability to move or feel on one side of the body, problems understanding or speaking, dizziness, or loss of vision to one side. If symptoms last less than one or two hours it is known as a transient ischemic attack (TIA) or mini-stroke. A hemorrhagic stroke may also be associated with a severe headache. The symptoms of a stroke can be permanent. Brain computed tomography or MRI may help diagnose stroke.
24 months after the date of randomization.
Number of participants with systemic embolism
Tijdsspanne: 24 months after the date of randomization.

An embolism is the lodging of an embolus, a blockage-causing piece of material, inside a blood vessel. The embolus is usually a blood clot (thrombus). An embolism can cause partial or total blockage of blood flow in the affected vessel.

An embolism in which the embolus is a piece of thrombus is called a thromboembolism.

An embolism is usually a pathological event, i.e., accompanying illness or injury. Sometimes it is created intentionally for a therapeutic reason, such as to stop bleeding or to kill a cancerous tumor by stopping its blood supply.

Embolism can be classified as to where it enters the circulation either in arteries or in veins. Arterial embolism are those that follow and, if not dissolved on the way, lodge in a more distal part of the systemic circulation.
24 months after the date of randomization.
Number of participants with cardiovascular/unexplained death
Tijdsspanne: 24 months after the date of randomization.
Cardiovascular deaths refer to deaths due to heart dysfunction, injury of cardiac structure, coronary artery diseases and lethal arrhythmias or sudden death that cannot be explain. Cardiovascular deaths can be diagnosed with clinical symptoms or from the results of diagnostic examinations.
24 months after the date of randomization.
Number of participants with major bleedings
Tijdsspanne: 24 months after the date of randomization.
Major bleedings refer to the heavy bleedings of the mains organs of the body, usually include intracranial bleeding and gastrointestinal bleeding et al.. Brain computed tomography and gastrointestinal endoscope are the common approaches for diagnosing major bleedings.
24 months after the date of randomization.
Number of participants with acute coronary syndrome
Tijdsspanne: 24 months after the date of randomization.

Acute coronary syndrome is a syndrome (set of signs and symptoms) due to decreased blood flow in the coronary arteries such that part of the heart muscle is unable to function properly or dies. The most common symptom is chest pain, often radiating to the left shoulder or angle of the jaw, crushing, central and associated with nausea and sweating. Many people with acute coronary syndromes present with symptoms other than chest pain, particularly, women, older patients, and patients with diabetes mellitus.

Acute coronary syndrome is commonly associated with three clinical manifestations, named according to the appearance of the electrocardiogram (ECG): ST elevation myocardial infarction (STEMI, 30%), non-ST elevation myocardial infarction (NSTEMI, 25%), or unstable angina (38%). There can be some variation as to which forms of myocardial infarction (MI) are classified under acute coronary syndrome.
24 months after the date of randomization.
Number of participants with coronary or periphery artery disease requiring revascularization
Tijdsspanne: 24 months after the date of randomization.
Conronary or periphery artery diseases, regardless stable or not, need revascularization by stent which require long-term aspirin therapy
24 months after the date of randomization.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of participants with device-related thrombus
Tijdsspanne: 24 months after the date of randomization.
This refers to the thrombus that is related to the implantation of the device for left atrial appendage closure. Transesophageal echocardiography is effective in identifying and diagnosing device-related thrombus.
24 months after the date of randomization.
Number of participants with minor bleedings
Tijdsspanne: 24 months after the date of randomization.
Minor bleedings refer to the bleedings acoording to the TIMI cirteria
24 months after the date of randomization.
Number of Participants with hospitalization due to heart failure
Tijdsspanne: 24 months after the date of randomization.
Patients need to receive treatments in hospital because of occurrence of heart failure or deterioration of heart failure.
24 months after the date of randomization.
Number of participants with all-cause death
Tijdsspanne: 24 months after the date of randomization.
any cause of death
24 months after the date of randomization.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Onderzoekers

  • Hoofdonderzoeker: Yi-Gang Li, Dr., Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juni 2020

Primaire voltooiing (Verwacht)

1 juni 2022

Studie voltooiing (Verwacht)

1 december 2024

Studieregistratiedata

Eerst ingediend

22 januari 2019

Eerst ingediend dat voldeed aan de QC-criteria

27 januari 2019

Eerst geplaatst (Werkelijk)

30 januari 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 oktober 2021

Laatste update ingediend die voldeed aan QC-criteria

9 oktober 2021

Laatst geverifieerd

1 juni 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • XH-18-017

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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