Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2
Dr David Hasan, M.D.
Summary
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.
Description
This is an exploratory, two-center, randomized, double-blinded study. The primary objective is to determine the maximum tolerated dosage (MTD) of tirofiban in the context of patients with aSAH status post-endovascular coiling. The dosage regimen of tirofiban will be 0.10µg/kg/min (actual weight) within 48 hours of aneurysm securing and within 72 hours of ictus. The study will involve a dose escalation stage and a cohort expansion stage. During the dosage-escalation stage, the intervention doses include continuous intravenous (IV) tirofiban or IV placebo for 1 day, 3 days, 5 days, or 7 days. D…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
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 Co…
Interventions
- DrugTirofiban
IV infusion at 0.10 microgram/kilogram/minute (mcg/kg/min) for 1 day, 3 days, 5 days, or 7 days according to the dose escalation procedure.
- DrugPlacebo
IV infusion at the same infusion duration as the study drug; same adjustments
Locations (2)
- Duke University Health SystemDurham, North Carolina
- University of Texas Health Sciences CenterHouston, Texas