REAl-life study on short-term Dual Antiplatelet treatment in Patients with ischemic stroke or Transient ischemic attack

Background and purpose: Clinical trials proved the efficacy of short-term dual antiplatelet therapy (DAPT) in secondary prevention of minor ischemic stroke or high-risk transient ischemic attack (TIA). In clinical practice, the use of short-term DAPT is broader than in clinical trials and procedures of clinical trials (i.e. loading dose, timely treatment start) are not always followed. We aimed at evaluating effectiveness and safety of short-term DAPT in real-world. Methods: READAPT (A REAl-life study on short-term Dual Antiplatelet treatment in Patients with ischemic stroke or Transient ischemic attack) ([NCT05476081][1]) was an observational multicenter real-world study with a 90-day follow-up. The enrollment closed on 28th February 2023. We included patients aged 18+ receiving DAPT after minor ischemic stroke or high-risk TIA but no stringent exclusion criteria were applied regarding stroke severity and ABCD2 score. Primary effectiveness outcome was stroke (ischemic or hemorrhagic) or death due to vascular causes, primary safety outcome was moderate-to-severe bleeding. Key secondary outcomes were the type of ischemic and hemorrhagic events, disability, cause of death, and compliance to treatment. Results: We included 1920 patients; the majority started DAPT after an ischemic stroke (69.9%) rather than a TIA. Primary effectiveness outcome occurred in 3.9% and primary safety outcome in 0.6% of cases. In total, 3.3% cerebrovascular ischemic recurrences occurred, 0.2% intracerebral hemorrhages, and 2.7% bleedings; 0.2% of patients died due to vascular causes. We compared different subgroups of patients and we found significant differences among patients with NIHSS score ?5 and those without acute lesions at neuroimaging who had higher primary effectiveness outcomes than their counterparts. Additionally, DAPT start after 24 hours from symptom onset was associated with a lower likelihood of bleeding. Conclusions: Short-term DAPT after ischemic stroke or TIA is effective and safe in real-world where a broader population receives the treatment and procedures may differ from clinical trials. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement The study is a non-profit study. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Internal Review Board of the University of L'Aquila (Italy) has cleared the study with the number 03/2021 I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data are available upon reasonable request to the Corresponding Author [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05476081&atom=%2Fmedrxiv%2Fearly%2F2024%2F01%2F11%2F2024.01.08.24301025.atom