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

October 9, 2021 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

1120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aspirin group
Study patients assigned to Aspirin group will receive enteric coated aspirin (100 mg/day).
Drug: Aspirin Tablet
Aspirin 100mg qd
Placebo Comparator: Control group
Study patients assigned to control group will receive placebo.
Drug: Placebo
Placebo qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with stroke
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with device-related thrombus
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 24 months after the date of randomization.
any cause of death
24 months after the date of randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

January 27, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-18-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Aspirin Tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe