Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPA… (NCT07493577) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
United States82 participantsStarted 2026-07-23
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …