Frontiers in Neurology (Oct 2024)

Optimal antithrombotic therapy in ischemic stroke patients with non-valvular atrial fibrillation and atherothrombosis: study protocol for a randomized controlled trial

  • Shuhei Okazaki,
  • Shuhei Okazaki,
  • Haruko Yamamoto,
  • Koko Asakura,
  • Katsuhiro Omae,
  • Hirotada Maeda,
  • Kanta Tanaka,
  • Shiro Yamamoto,
  • Teruyuki Hirano,
  • Yasuyuki Iguchi,
  • Manabu Sakaguchi,
  • Masatoshi Koga,
  • Masafumi Ihara,
  • Kazunori Toyoda,
  • Teruo Noguchi,
  • Nobuyuki Sakai,
  • Hiroshi Yamagami,
  • Hiroshi Yamagami

DOI
https://doi.org/10.3389/fneur.2024.1468523
Journal volume & issue
Vol. 15

Abstract

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BackgroundThe addition of antiplatelet therapy to anticoagulant therapy in patients with stroke with non-valvular atrial fibrillation (NVAF) and atherothrombotic disease may increase bleeding risk without reducing recurrent stroke risk.AimsTo evaluate the clinical benefits of anticoagulant monotherapy compared to combination therapy with anticoagulants and antiplatelet agents.Methods and designThis is an investigator-initiated prospective multicenter, randomized, open-label, parallel-group clinical trial. Patients with NVAF and atherothrombotic disease who have had a recent ischemic stroke or transient ischemic attack will be eligible to participate in this trial.Study outcomesThe primary outcome is a composite of ischemic cardiovascular events, including cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, ischemic events requiring urgent revascularization, and major bleeding events within 2 years after randomization.Sample size estimatesThis study will enroll 400 patients, 200 receiving anticoagulant monotherapy and 200 receiving combination therapy. This sample size will provide 90% power (one-sided p = 0.025) to detect a risk reduction in outcome events within 2 years, assuming event rates of 13 and 27% for each group, respectively, and a 10% loss to follow-up at a 2.5% significance level with one-sided log-rank tests at an interim analysis and a final analysis.DiscussionThis will be the first study to assess the net clinical benefit of oral anticoagulant monotherapy in ischemic stroke patients with NVAF and atherothrombosis.Clinical trial registrationhttps://clinicaltrials.gov/study/NCT03062319, NCT03062319; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000029222, UMIN000025392; https://jrct.niph.go.jp/latest-detail/jRCTs051180202, jRCTs051180202.

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