Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)

Other criteria

• Inclusion:
• Age 18-85
• Baseline Modified Rankin Scale (mRS) 0-3 (pre-SAH)
• SAH attributed to ruptured cerebral aneurysm
• Admission Computed Tomography (CT) scan shows Modified Fisher grade 1-4 due to aSAH primarily in the supratentorial space
• World Federation of Neurosurgical Societies (WFNS) scale grade ≤4 at randomization
• Onset of symptoms of aSAH (ictus) occurred <72 hours prior to presentation
• If External Ventricular Drain (EVD) placed, placement is ≥12 hours prior to enrollment
• 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
• Participant can be randomized within 48 hours of aneurysm treatment
• Participant or participant's legally-authorized representative (LAR) has provided documented informed consent; Exclusion:
• Angio-negative SAH, defined as a SAH with a digital subtraction angiogram that does not show an intracranial aneurysm
• Surgical clipping prior of the ruptured aneurysm or any non-ruptured aneurysm on the same admission to enrollment
• Remaining untreated aneurysm(s) that could reasonably be considered a possible alternate cause of the aSAH based on the observed bleeding pattern
• Uncontrollable hypertension (>180 systolic and/or >110 diastolic) that is not correctable prior to enrollment
• Active internal bleeding, or history of bleeding diathesis, major surgical procedure, or severe physical trauma within the previous month (30 days)
• A medical diagnosis that requires continuous use of aspirin, clopidogrel, ticagrelor, or tirofiban during the study drug infusion
• New parenchymal hemorrhage or new infarction larger than 15 cubic centimeters (cc) in volume by CT
• Thrombolytic therapy within 24 hours prior to enrollment (alteplase, tenecteplase, or urokinase)
• Previous intracranial hemorrhage, intracranial neoplasm, subarachnoid hemorrhage, or arterial-venous malformation
• Thrombocytopenia (platelet count <100,000/microliter (µL) assuming clumping is ruled out
• Allergy or intolerance to tirofiban
• Pregnant or lactating
• Chronic kidney disease with creatinine clearance (CrCl ≤ 30 milliliters per minute [ml/min]) or acute kidney injury (AKI) at study screening. AKI is defined as:; Increase in serum creatinine by 0.3 milligrams per deciliter (mg/dL) or more (26.5 micromoles per liter [μmol/L] 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/kg/hour for at least 6 hours