Last updated on June 2019

Safety of Terminating the Use of Aspirin After Left Atrial Appendage Closure

Brief description of study

This study is a prospective, randomized, non-inferiority study aimed at investigating the safety of terminating the use of aspirin since the sixth month after left atrial appendage closure (LAAC).

Patients diagnosed with paroxysmal or persistent atrial fibrillation with an age between 18 and 85 years and have undergone LAAC or LAAC in combination with catheter ablation (CA) will be enrolled in this study. After the procedure of LAAC or LAAC in combination with CA, patients will receive warfarin or novel oral anticoagulants for 45 days and then switch to the dual-antiplatelet therapy with aspirin and clopidogrel until the sixth month. Six months after the procedure, patients will be divided randomly into two groups. In the first group, patients will terminate the use of both aspirin and clopidogrel. In the other group, patients will continue to use aspirin for antiplatelet therapy lifelong. For each group, 490 patients will be included, with an estimated total number of 980 participants in this clinical study. Patients will be followed up for 24 months.

During the follow-up, the events of stroke/TIA, systematic embolism, major bleedings, unexplained/cardiovascular death, device-related thrombus, and hospitalization due to heart failure et al. will be identified and recorded. Patients will be followed-up in 3, 6, 12 and 24 months for clinical events. Items including 12-leads ECG, 24h Holter ECG, transesophageal echocardiography and transthoracic echocardiography, will be performed and NT-proBNP and inflammatory cytokines will be measured at 12 months. .Statistics analysis will be performed to compare the differences between the two groups in the events of primary and secondary endpoints. The investigators hypothesize that terminating the use of aspirin at the sixth month after LAAC will be non-inferior to continuing using aspirin.

Detailed Study Description

This study is a perspective and randomized non-inferiority clinical trial investigating the safety of terminating the use of aspirin since the sixth month after LAAC in patients with atrial fibrillation. The investigators and sponsors will work together to develop research protocols, case report forms, research medical records, and informed consent in accordance with the Declaration of Helsinki. Research related materials will be reported to the Medical Ethics Committee for review and approval. All included patients will sign the informed consent form and be followed-up regularly for clinical outcomes and adverse events.

This study will be conducted in accordance with the following procedures:

  1. Screen out 240 patients in accordance with the inclusion and exclusion criteria. The screening period begins with the subject signing the informed consent form and until the subject begins receiving an intervention. Usually, the subject's written informed consent must be obtained prior to any trial-related procedures. If the subject has received physical examinations and laboratory tests within 2 weeks prior to screening after admission, the participants may also sign informed consent and use the results as screening data. After obtaining informed consent, the subject's basic information is recorded in the "subject screening form." The following screening assessments should be made: demographic data, medical history, physical examination, vital signs data, the height and body weight, laboratory parameters, ECG examination, assessment for medication and evaluation for inclusion/exclusion criteria.
  2. After enrollment, participants will be randomly divided into two groups through a computer-based randomization program. Then the patients will either terminate the use of aspirin or continue the use of aspirin in accordance with the result of randomization. Participants will be assessed and observed carefully throughout the procedure of the study.
  3. The participants will be followed-up in 3, 6, 12 and 24 months after randomization for clinical events after the intervention. The main follow-up includes a review of ECG, 24h Holter, echocardiography, transesophageal echocardiography, coronary CT, biomarker (NT-pro-BNP) and inflammatory cytokines, including tumor necrosis factor -alpha, interleukin-6 and monocyte chemoattractant protein 1 (MCP1) et al. and also brain CT or MRI if necessary, at the 12 months after randomization. Participants' medication and symptoms will also be observed and recorded. The incidences of stroke, systemic embolism, and cardiovascular death; the incidences of device-related thrombus, major bleedings, and hospitalization due to heart failure will be recorded. Adverse events during the trial will also be assessed and recorded.
  4. Collect research data and perform the statistical analysis. For Statistical analysis, the sample size calculation is based on the overall incidence of stroke, systemic embolism, and cardiovascular death. The study includes multiple endpoint tests that would use a 5% significance level with a test efficacy of 90%. Assume that 10% of patients have withdrawn from the middle and 10% have lost follow-up. According to the literature and most experts, the total proportion of stroke, transient ischemic stroke, systemic embolism, major bleeding and cardiovascular/unexplained death in patients with atrial fibrillation are 5.0/100 person-years after LAAC. The investigators estimate that terminating the use of aspirin will not influence the incidence of the composite endpoint of stroke, transient ischemic stroke, systemic embolism, major bleeding and cardiovascular/unexplained death. The rate of the composite endpoint events is 5/100 person-years. The preset non-inferiority margin for this study is 1.7. According to the sample size estimation formula, the number of trials should be 980 patients (490 in each group).

The overall timing of the trial: patients' enrollment and treatment will be completed from February 2019 to January 2021. The last participants will be followed-up for 1 year after completion of the treatment. It is expected that the trial will be completed in a total of 36 months by January 2022.

Clinical Study Identifier: NCT03821883

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