[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612358":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":45,"centralContacts":50,"locations":11,"responsibleParty":60,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":11,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":11,"enrollmentInfo":75,"targetDuration":11,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":11,"overallStatus":86,"whyStopped":11,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":11},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"isosorbide mononitrate plus butylphthalide","EXPERIMENTAL",null,[13,14],"Drug: Isosorbide Mononitrate","Drug: Butylphthalide",{"label":16,"type":10,"description":11,"interventionNames":17},"isosorbide mononitrate plus butylphthalide placebo",[13,18],"Drug: Butylphthalide Placebo",{"label":20,"type":10,"description":11,"interventionNames":21},"isosorbide mononitrate placebo plus butylphthalide",[14,22],"Drug: Isosorbide Mononitrate Placebo",{"label":24,"type":25,"description":11,"interventionNames":26},"isosorbide mononitrate placebo plus butylphthalide placebo","PLACEBO_COMPARATOR",[22,18],[28,33,37,41],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"DRUG","Isosorbide Mononitrate","Days 1-7: Isosorbide mononitrate injection, 20 mg once daily by intravenous infusion.\n\nDays 8-6 months: Isosorbide mononitrate sustained-release tablets, 40 mg once daily orally (dose reduced to 20 mg once daily during the final week).",[9,16],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"Butylphthalide","Days 1-7: Butylphthalide injection, 25 mg twice daily by intravenous infusion.\n\nDays 8-6 months: Butylphthalide soft capsules, 200 mg three times daily orally.",[20,9],{"type":29,"name":38,"description":39,"armGroupLabels":40,"otherNames":11},"Isosorbide Mononitrate Placebo","Days 1-7: Isosorbide mononitrate injection placebo, once daily by intravenous infusion.\n\nDays 8-6 months: Isosorbide mononitrate sustained-release tablet placebo, once daily orally (dose reduced to half a tablet once daily during the final week).",[20,24],{"type":29,"name":42,"description":43,"armGroupLabels":44,"otherNames":11},"Butylphthalide Placebo","Days 1-7: Butylphthalide injection placebo, twice daily by intravenous infusion.\n\nDays 8-6 months: Butylphthalide soft capsule placebo, 2 capsules three times daily orally.",[24,16],[46],{"name":47,"affiliation":48,"role":49},"Yilong Wang","Beiling Tiantan Hospital, Capital Medical University","PRINCIPAL_INVESTIGATOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":11,"email":55},"Ying Gao","CONTACT","+86 10 59976165","tjssgaoying@163.com",{"name":57,"role":53,"phone":58,"phoneExt":11,"email":59},"Yao Lu","+86 10 59976254","luyao970131@163.com",{"type":49,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"yilong Wang","Professor",[64],{"name":65,"class":6},"Shenzhen Second People's Hospital","100612358","phase-3-isosorbide-mononitrate-and-butylphthalide-to-reduce-the-risk-of-disability-in-patients-with-acute-lacunar-stroke-impact-100612358",false,"NCT07252544","Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT)","Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke: a 2×2 Factorial Randomized Controlled Trial (IMPACT)","Inclusion Criteria:\n\n1. Age ≥ 30 years;\n2. Clinical lacunar syndrome within 7 days;\n3. Brain CT\u002FMRI after symptom onset:\n\n   1. a relevant (in time and location) acute lacunar infarct;\n   2. if no relevant lesion, symptom duration \\>24 hours, with no other suspected stroke etiologies (such as cerebral hemorrhage, cortical infarction, seizures, etc.)\n4. MoCA score meeting the following criteria:\n\n   1. MoCA ≥ 13 if educated ≤ 6 years;\n   2. MoCA ≥ 15 if 7 ≤ educated ≤ 12 years;\n   3. MoCA ≥ 18 if educated ≥ 13 years；\n5. mRS ≤ 1 prior to this episode;\n6. Patient or a legally authorized representative signed informed consent.\n\nExclusion Criteria:\n\n1. Ischemic stroke of large artery atherosclerosis, cardioembolism, or other etiologies (TOAST classification);\n2. Diagnosed or suspected hereditary CSVD;\n3. Intracerebral hemorrhage within the past 3 months including parenchymal, intraventricular, subarachnoid hemorrhage, subdural\u002Fepidural hematoma;\n4. 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.\n5. Previously diagnosed psychiatric disorders (DSM-5 criteria).\n6. Other active neurological disorders (e.g., recurrent seizures, brain tumors, vascular malformations, untreated aneurysms \\>3 mm).\n7. Hypotension (seated systolic blood pressure \\\u003C100 mmHg), bradycardia (heart rate \\\u003C60 bpm), sick sinus syndrome or severe cardiopulmonary disease.\n8. History of congestive heart failure, acute myocardial infarction or other severe cardiac dysfunctions (NYHA Class III-IV).\n9. Coagulation disorders, bleeding tendency or systemic bleeding, including but not limited to prothrombin time \\>3×upper limit of normal (ULN), platelet count \\\u003C50×109\u002FL, hemophilia, capillary fragility, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, or vitreous hemorrhage, etc.\n10. Severe hepatic or renal insufficiency (note: severe hepatic insufficiency is defined as ALT or AST \\> 3×ULN or acute hepatitis, chronic active hepatitis, cirrhosis; severe renal insufficiency is defined as eGFR \\\u003C 45 ml\u002Fmin\u002F1.73m², creatinine clearance \\\u003C 40 ml\u002Fmin, or known chronic kidney disease of stage 3 or higher).\n11. Head trauma, intracranial or spinal surgery, major surgical procedures or severe trauma within the past 4 weeks.\n12. ISMN or NBP use within the past 3 days.\n13. Have contraindications to ISMN or NBP, or allergy to their components.\n14. Have to use the contraindicated drugs of this trial for a long time.\n15. Pregnant, breastfeeding or planning to pregnant during this study.\n16. Unable to tolerate MRI or with MRI contraindications.\n17. Have severe diseases or expected survival \\\u003C12 months.\n18. Participate in other clinical trials within 30 days before this trial.\n19. Unlikely to comply with study procedures and follow-up procedures for whatever reason in the opinion of the research physician.","ALL","30 Years",{"count":76,"type":77},3156,"ESTIMATED","INTERVENTIONAL",[80],"PHASE3","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.",[83,84,85],"Stroke, Lacunar","Stroke, Acute Ischemic","Cerebral Small Vessel Diseases","NOT_YET_RECRUITING","2025-11-24",{"date":89,"type":90},"2025-11-26","ACTUAL",{"date":92,"type":77},"2025-12-01",{"date":94,"type":77},"2028-02-29",{"name":5,"class":6}]