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NCT03821883: ASPIRIN-LAAO

Aspirin Discontinuation After Left Atrial Appendage Occlusion in Atrial Fibrillation

Status unknown NA Last updated 12 October 2021
What this trial tests

NA trial testing Aspirin Tablet in Atrial Fibrillation in 1,120 participants. Status unknown.

Timeline
1 June 2020
Primary endpoint
1 June 2022
1 December 2024

Quick facts

Lead sponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment1,120
Start date1 June 2020
Primary completion1 June 2022
Estimated completion1 December 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Who can join

Adults 18 to 90, any sex, with Atrial Fibrillation or Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Left atrial appendage occlusion.
    Holmes DR, Korsholm K, Rodés-Cabau J, Saw J, et al · · 2023 · cited 74× · PMID 36760206 · DOI 10.4244/eij-d-22-00627
  2. Antithrombotic Therapy after Percutaneous Left Atrial Appendage Closure: Evidence, Challenges and Future Directions.
    Galea R, Räber L. · · 2023 · cited 9× · PMID 39077095 · DOI 10.31083/j.rcm2412343
  3. Left Atrial Appendage Closure: A Narrative Review.
    Nagasaka T, Nakamura M. · · 2023 · cited 8× · PMID 37938523 · DOI 10.1007/s40119-023-00337-2
  4. Antithrombotic therapy for transcatheter structural heart intervention.
    Guedeney P, Rodés-Cabau J, Ten Berg JM, Windecker S, et al · · 2024 · cited 6× · PMID 39155752 · DOI 10.4244/eij-d-23-01084
  5. Percutaneous Left Atrial Appendage Occlusion-Current Evidence and Future Directions.
    Rotta Detto Loria J, Desch S, Pöss J, Kirsch K, et al · · 2023 · cited 6× · PMID 38068344 · DOI 10.3390/jcm12237292
  6. Percutaneous Left Atrial Appendage Occlusion Therapy: Evolution and Growing Evidence.
    Han X, Benditt DG. · · 2023 · cited 4× · PMID 39077005 · DOI 10.31083/j.rcm2407211
  7. Left Atrial Appendage Occlusion and Post-procedural Antithrombotic Management.
    Kramer A, Patti G, Nielsen-Kudsk JE, Berti S, et al · · 2024 · cited 4× · PMID 38337496 · DOI 10.3390/jcm13030803
  8. Double-blind, placebo-controlled randomised clinical trial to evaluate the effect of ASPIRIN discontinuation after left atrial appendage occlusion in atrial fibrillation: protocol of the ASPIRIN LAAO trial.
    Chen M, Wang Q, Sun J, Zhang PP, et al · · 2021 · cited 3× · PMID 33722871 · DOI 10.1136/bmjopen-2020-044695

Verify or expand the search:

Other trials of Aspirin Tablet

Trials testing the same drug.

Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

Other Xinhua Hospital, Shanghai Jiao Tong University School of Medicine trials

Trials by the same sponsor.

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Data sources for this page

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