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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821883
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Bleeding Drug: Aspirin Tablet Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Aspirin Discontinuation After Left Atrial Appendage Occlusion in Atrial Fibrillation
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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




Primary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.

  4. 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.

  5. 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.


  6. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. Number of participants with all-cause death [ Time Frame: 24 months after the date of randomization. ]
    any cause of death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821883


Contacts
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Contact: Mu Chen, Dr. 86 021 25077275 chenmu@xinhuamed.com.cn

Locations
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China, Shanghai
Xinhua Hospital, School of Medicne, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200092
Contact: Yi-Gang Li, Dr.    86 021 25077275    liyigang@xinhuamed.com.cn   
Principal Investigator: Yi-Gang Li, MD         
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Yi-Gang Li, Dr. Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University
Publications of Results:

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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03821883    
Other Study ID Numbers: XH-18-017
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
Atrial fibrillation
Stroke
Left atrial appendage closure
Aspirin
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics