Aspirin Discontinuation After Left Atrial Appendage Occlusion in Atrial Fibrillation
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine