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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    1120
  • sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Updated on 9 February 2022
aspirin
clot
stroke
heart failure
atrial fibrillation
fibrillation
acute coronary syndrome
vascular disease
embolism
left atrial appendage occlusion

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.

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.

Details
Condition Atrial Fibrillation, Stroke, Bleeding
Treatment Placebo, Termination of aspirin, Aspirin Tablet
Clinical Study IdentifierNCT03821883
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Last Modified on9 February 2022

Eligibility

Yes No Not Sure

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
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