The goal of this multicenter, double-blind, 2×2 factorial randomized controlled trial is to evaluate the efficacy and safety of isosorbide mononitrate, butylphthalide, and their combination in reducing disability in patients with acute lacunar stroke.
Age ≥ 30 years;
Clinical lacunar syndrome within 7 days;
a relevant (in time and location) acute lacunar infarct;
if no relevant lesion, symptom duration >24 hours, with no other suspected stroke etiologies (such as cerebral hemorrhage, cortical infarction, seizures, etc.)
Ischemic stroke of large artery atherosclerosis, cardioembolism, or other etiologies (TOAST classification);
Diagnosed or suspected hereditary CSVD;
Intracerebral hemorrhage within the past 3 months including parenchymal, intraventricular, subarachnoid hemorrhage, subdural/epidural hematoma;
Neurodegenerative diseases or systemic diseases that may lead to cognitive impairment, such as Alzheimer's disease, mixed dementia, Parkinson's disease, systemic autoimmune diseases, hepatic encephalopathy, or uremic encephalopathy.
Beijing Tiantan Hospital
Lead sponsor
Shenzhen Second People's Hospital
Collaborator