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Phase 1/2a Trial of ISPASM.

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  • 1Department of Neurosurgery (M.Z., A.P., E.R., D.H.), University of Iowa Hospital and Clinics.

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Summary

Tirofiban, an antiplatelet agent, reduced delayed cerebral ischemia and vasospasm in aneurysmal subarachnoid hemorrhage patients. This study suggests tirofiban is safe and effective, warranting further investigation in larger trials.

Keywords:
aneurysmincidencesubarachnoid hemorrhagethrombosistirofiban

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Area of Science:

  • Neurology
  • Cardiovascular Medicine
  • Pharmacology

Background:

  • Microthrombosis is implicated in delayed cerebral ischemia (DCI) following aneurysmal subarachnoid hemorrhage (aSAH).
  • Retrospective studies suggest tirofiban may reduce DCI, but its safety in aSAH is not well-established.

Purpose of the Study:

  • To assess the safety and preliminary efficacy of a 7-day intravenous tirofiban infusion in patients with aSAH.
  • To evaluate intracranial hemorrhage, vasospasm, and DCI as outcomes.

Main Methods:

  • Phase 1/2a, double-blind, randomized controlled trial (2:1 randomization) comparing tirofiban to placebo.
  • Patients received ventriculostomy and coiling for aSAH.
  • Primary endpoint: intracranial hemorrhage; Secondary endpoints: vasospasm, DCI, ischemic changes on imaging.

Main Results:

  • 18 patients received tirofiban, 12 received placebo. No significant differences in death, hemorrhage, or thrombocytopenia.
  • Tirofiban group showed significantly lower incidence of DCI (6% vs. 33%, P=0.04).
  • Reduced radiographic vasospasm observed in the tirofiban group (P=0.01 for CTA and CT perfusion).

Conclusions:

  • Preliminary results support further investigation of tirofiban's safety and efficacy in a larger, multicenter trial.
  • A 7-day intravenous infusion of tirofiban appears safe and potentially effective for managing aSAH.
  • The findings encourage progression to larger pragmatic trials.