Imagine you’re building a house, but the materials keep falling apart. That’s what it’s like for patients with severe spontaneous intracerebral hemorrhage (sSICH) who have a high risk of ischemic events. They need antiplatelet therapy to prevent major cardiovascular and cerebrovascular events, but the risk of severe bleeding complicates matters. In this exciting new study, researchers are conducting a randomized controlled trial called E-start to investigate the benefits and safety of starting antiplatelet therapy early after surgery for sSICH patients with high ischemic event risks. By enrolling 250 patients and dividing them into two groups, the researchers will compare the incidence of postoperative major cardiovascular/cerebrovascular and peripheral vascular events (MACCPE). The early-start group will receive aspirin 100 mg daily starting three days after surgery, while the normal-start group will delay treatment until day 30. The primary endpoint is the incidence of MACCPE, and the secondary endpoint is intracranial re-hemorrhage. This groundbreaking trial will provide valuable evidence for improving postoperative management strategies in the future. Take a look at the full study to dive deeper into this important research!

BackgroundFor severe spontaneous intracerebral hemorrhage (sSICH) patients with high risk of ischemic events, the incidence of postoperative major cardiovascular/cerebrovascular and peripheral vascular events (MACCPE) is notable. Although antiplatelet therapy is a potential way to benefit these patients, the severe hemorrhagic complications, e.g., intracranial re-hemorrhage, is a barrier for early starting antiplatelet therapy.ObjectivesThis randomized controlled trial aims to identify the benefit and safety of early starting antiplatelet therapy after operation for sSICH patients with high risk of ischemic events.MethodsThis study is a multicenter, prospective, randomized, open-label, blinded-endpoint trial. We will enroll 250 sSICH patients with a high risk of ischemic events (including cerebral infarcts, transient ischemic attack, myocardial infarction, pulmonary embolism, and deep venous thrombosis). The participants will be randomized in a 1:1 manner to early-start group (start antiplatelet therapy at 3 days after operation) and normal-start group (start antiplatelet therapy at 30 days after operation). The early-start group will receive aspirin 100 mg daily. The control group will not receive antithrombotic therapy until 30 days after operation. The efficacy endpoint is the incidence of MACCPE, and the safety endpoint is the incidence of intracranial re-hemorrhage.DiscussionThe Early-Start antiplatelet therapy after operation in patients with spontaneous intracerebral hemorrhage trial (E-start) is the first randomized trial about early start antiplatelet therapy for operated sSICH patients with a high risk of ischemic events. This study will provide a new strategy and evidence for postoperative management in the future.Clinical trial registrationClinicalTrials.gov, identifier NCT04820972; Available at: https://clinicaltrials.gov/ct2/show/NCT04820972?term=NCT04820972&draw=2&rank=1.Chinese Clinical Trial Registry, identifier ChiCTR2100044560; Available at: http://www.chictr.org.cn/showproj.aspx?proj=123277.

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