Health Trials

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

ConditionAneurysmal Subarachnoid Hemorrhage
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

Locations

2
Duke University Health System27710, DurhamNorth Carolina, United States
University of Texas Health Sciences Center77030, HoustonTexas, United States

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

Source ClinicalTrials.gov