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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorDr David Hasan, M.D.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Tirofiban
  • Placebo

Treatment groups

82 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dr David Hasan, M.D.

Lead sponsor

Duke University

Sponsor institution

National Institutes of Health (NIH)

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator