Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute… (NCT07252544) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT)
3,156 participantsStarted 2025-12-01
Plain-language summary
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.
Who can participate
Age range30 Years
SexALL
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Inclusion criteria
✓. Age ≥ 30 years;
✓. Clinical lacunar syndrome within 7 days;
✓. Brain CT/MRI after symptom onset:
✓. 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.)
✓. MoCA score meeting the following criteria:
✓. MoCA ≥ 13 if educated ≤ 6 years;
✓. MoCA ≥ 15 if 7 ≤ educated ≤ 12 years;
Exclusion criteria
✕. 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.