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

A vizsgálat adatai

Ki végzi

Dr David Hasan, M.D.

Azonosító

NCT07493577

A regiszteradat frissítve

2026. november 4.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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

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.

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.

ClinicalTrials.gov NCT07493577