Not yet taking people in United StatesPhase 1/2

Tirofiban dose safety after coiling for bleeding from a brain aneurysm

Tests tirofiban against placebo in adults with aneurysmal subarachnoid hemorrhage after coiling.

Key facts

Who runs it: Dr David Hasan, M.D.
Where: Durham and Houston, United StatesSee the 2 sites
Trial code: NCT07493577
Registry title: Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Status: Not yet recruiting
Phase: Phase 1/2
People taking part: 82 people, planned
Starts: 5 Dec 2026
Expected to end: 5 May 2032
Type of study: Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested: Tirofiban
Placebo
Record updated: 4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with bleeding around the brain from a burst brain aneurysm (aSAH), treated with endovascular coiling. It tests different lengths of tirofiban infusion against placebo.

Age: 18 to 85 years
Sex: All sexes
Disease stage: Bleeding from a ruptured brain aneurysm, mainly in the upper part of the brain. Modified Fisher grade 1-4 on the admission CT scan. WFNS grade ≤4 at randomization. Symptoms started <72 hours before arrival at hospital. Modified Rankin Scale 0-3 before the bleed.
Earlier treatment: All aneurysms thought to have caused the bleed must be closed with endovascular coils, with a Raymond-Roy Score of 1 or 2. People must be randomized within 48 hours of this treatment. If a brain drain (EVD) was placed, it must be ≥12 hours before enrolment. People cannot join after surgical clipping of an aneurysm, or after clot-dissolving drugs (alteplase, tenecteplase, urokinase) within 24 hours.
Biomarker or test result: Platelet count must not be below 100,000/microliter (µL).

Main reasons for not taking part

Active internal bleeding, a bleeding disorder, major surgery or severe injury in the past 30 days
Needing aspirin, clopidogrel, ticagrelor or tirofiban during the study infusion
Earlier brain bleeding, brain tumour or arterial-venous malformation
Severe kidney disease (CrCl ≤ 30 ml/min) or sudden kidney injury
Pregnant or breastfeeding, uncontrolled high blood pressure (>180 systolic and/or >110 diastolic), or allergy to tirofiban

The registry criteria, word for word

Show all 24 criteriaShow less

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 85 years old?

Where in United States

Duke University Health SystemDurham, United StatesContact: Hazani Benitez-Rosas, ASNot yet recruiting
University of Texas Health Sciences CenterHouston, United StatesContact: Sprios Blackburn, MDNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

TirofibanTreatment being tested
Continuous IV infusion of tirofiban for 1, 3, 5, or 7 days post-endovascular coiling.
PlaceboPlacebo, for comparison
Continuous IV infusion of saline placebo for 1, 3, 5, or 7 days post-endovascular coiling.