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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Dr David Hasan, M.D.
Study ID
NCT07493577
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Aneurysmal Subarachnoid Hemorrhage

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirofiban — DRUG
    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.
  • Placebo — DRUG
    IV infusion at the same infusion duration as the study drug; same adjustments

Study Details

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.

Key Dates

Start date
Jul 23, 2026
Status verified
Mar 2026
Primary completion
Jan 23, 2029
Completion
Jan 23, 2032

Study Design

Enrollment
82 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirofiban
    Continuous IV infusion of tirofiban for 1, 3, 5, or 7 days post-endovascular coiling.
  • Placebo Comparator: Placebo
    Continuous IV infusion of saline placebo for 1, 3, 5, or 7 days post-endovascular coiling.

Primary Outcome Measure

Tirofiban dosage-limiting toxicity (DLT) [ Time Frame: Within 14 days post-randomization ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Duke University Health SystemDurhamNorth Carolina27710
Hazani Benitez-Rosas, AS
[email protected]
919-681-4974
Beth A Perry, RN
[email protected]
919-681-2695
Emad Hasan, MD (PRINCIPAL_INVESTIGATOR)
Brian Mac Grory, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Sciences CenterHoustonTexas77030
Sprios Blackburn, MD
[email protected]
713-486-8000
Spiros Blackburn, MD (PRINCIPAL_INVESTIGATOR)

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