[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630892":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":38,"locations":49,"responsibleParty":87,"collaborators":91,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":43,"studyType":111,"phases":112,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":122,"whyStopped":43,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Duke University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tirofiban","EXPERIMENTAL","Continuous IV infusion of tirofiban for 1, 3, 5, or 7 days post-endovascular coiling.",[13],"Drug: Tirofiban",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Continuous IV infusion of saline placebo for 1, 3, 5, or 7 days post-endovascular coiling.",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","IV infusion at 0.10 microgram\u002Fkilogram\u002Fminute (mcg\u002Fkg\u002Fmin) for 1 day, 3 days, 5 days, or 7 days according to the dose escalation procedure.",[9],[26],"Aggrastat ®",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"IV infusion at the same infusion duration as the study drug; same adjustments",[15],[31],"Normal Saline",[33,36],{"name":34,"affiliation":5,"role":35},"Emad Hasan, MD","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":5,"role":35},"Brian Mac Grory, MD",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Hazani Benitez-Rosas","CONTACT","919-681-4974",null,"hazani.benitez-rosas@duke.edu",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Beth Perry","919-681-2695","beth.perry@duke.edu",[50,70],{"facility":51,"status":43,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Duke University Health System","Durham","North Carolina","27710","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-78.89862,35.99403,{"lat":61,"lon":60},[64,66,68,69],{"name":65,"role":41,"phone":42,"phoneExt":43,"email":44},"Hazani Benitez-Rosas, AS",{"name":67,"role":41,"phone":47,"phoneExt":43,"email":48},"Beth A Perry, RN",{"name":34,"role":35,"phone":43,"phoneExt":43,"email":43},{"name":37,"role":35,"phone":43,"phoneExt":43,"email":43},{"facility":71,"status":43,"city":72,"state":73,"zip":74,"country":55,"countryCode":56,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"University of Texas Health Sciences Center","Houston","Texas","77030",{"type":58,"coordinates":76},[77,78],-95.36327,29.76328,{"lat":78,"lon":77},[81,85],{"name":82,"role":41,"phone":83,"phoneExt":43,"email":84},"Sprios Blackburn, MD","713-486-8000","Spiros.Blackburn@uth.tmc.edu",{"name":86,"role":35,"phone":43,"phoneExt":43,"email":43},"Spiros Blackburn, MD",{"type":88,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Dr David Hasan, M.D.","Professor of Neurosurgery",[92,95],{"name":93,"class":94},"National Institutes of Health (NIH)","NIH",{"name":96,"class":94},"National Institute of Neurological Disorders and Stroke (NINDS)","100630892","phase-1-induced-suppression-of-platelet-activity-in-aneurysmal-subarachnoid-hemorrhage-management-2-ispasm-2-100630892",false,"NCT07493577","Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)","Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2","iSPASM-2","Inclusion:\n\n* Age 18-85\n* Baseline Modified Rankin Scale (mRS) 0-3 (pre-SAH)\n* SAH attributed to ruptured cerebral aneurysm\n* Admission Computed Tomography (CT) scan shows Modified Fisher grade 1-4 due to aSAH primarily in the supratentorial space\n* World Federation of Neurosurgical Societies (WFNS) scale grade ≤4 at randomization\n* Onset of symptoms of aSAH (ictus) occurred \\\u003C72 hours prior to presentation\n* If External Ventricular Drain (EVD) placed, placement is ≥12 hours prior to enrollment\n* All aneurysm(s) suspected to be responsible for the hemorrhage must be secured via Endovascular Coil Embolization with a post-embolization Raymond-Roy Score of 1 (Complete) or 2 (Residual Neck) prior to enrollment\n* Participant can be randomized within 48 hours of aneurysm treatment\n* Participant or participant's legally-authorized representative (LAR) has provided documented informed consent\n\nExclusion:\n\n* Angio-negative SAH, defined as a SAH with a digital subtraction angiogram that does not show an intracranial aneurysm\n* Surgical clipping prior of the ruptured aneurysm or any non-ruptured aneurysm on the same admission to enrollment\n* Remaining untreated aneurysm(s) that could reasonably be considered a possible alternate cause of the aSAH based on the observed bleeding pattern\n* Uncontrollable hypertension (\\>180 systolic and\u002For \\>110 diastolic) that is not correctable prior to enrollment\n* Active internal bleeding, or history of bleeding diathesis, major surgical procedure, or severe physical trauma within the previous month (30 days)\n* A medical diagnosis that requires continuous use of aspirin, clopidogrel, ticagrelor, or tirofiban during the study drug infusion\n* New parenchymal hemorrhage or new infarction larger than 15 cubic centimeters (cc) in volume by CT\n* Thrombolytic therapy within 24 hours prior to enrollment (alteplase, tenecteplase, or urokinase)\n* Previous intracranial hemorrhage, intracranial neoplasm, subarachnoid hemorrhage, or arterial-venous malformation\n* Thrombocytopenia (platelet count \\\u003C100,000\u002Fmicroliter (µL) assuming clumping is ruled out\n* Allergy or intolerance to tirofiban\n* Pregnant or lactating\n* Chronic kidney disease with creatinine clearance (CrCl ≤ 30 milliliters per minute \\[ml\u002Fmin\\]) or acute kidney injury (AKI) at study screening. AKI is defined as:\n\n  i) Increase in serum creatinine by 0.3 milligrams per deciliter (mg\u002FdL) or more (26.5 micromoles per liter \\[μmol\u002FL\\] or more) within 48 hour period; OR ii) Increase in serum creatinine to 1.5 times or more than the baseline of the prior 7 day period; OR iii) Urine volume less than 0.5 ml\u002Fkg\u002Fhour for at least 6 hours","ALL","18 Years","85 Years",{"count":109,"type":110},82,"ESTIMATED","INTERVENTIONAL",[113,114],"PHASE1","PHASE2","An exploratory, randomized, double-blinded, placebo-controlled, two-center clinical trial to determine the maximum tolerated dosage of intravenous tirofiban in patients with aneurysmal subarachnoid hemorrhage (aSAH) post-endovascular coiling. The study will also assess pharmacology and safety, with exploratory endpoints including delayed cerebral ischemia (DCI), vasospasm, and functional outcomes.",[117],"Aneurysmal Subarachnoid Hemorrhage",[119,120,9,121],"Subarachnoid Hemorrhage","Delayed Cerebral Ischemia","Brain Aneurysm Rupture","NOT_YET_RECRUITING","2026-03-23",{"date":125,"type":126},"2026-03-25","ACTUAL",{"date":128,"type":110},"2026-07-23",{"date":130,"type":110},"2032-01-23",{"name":89,"class":6},2]