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

NCT07493577 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-03-25

No results posted yet for this study

Summary

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.

Conditions

  • Aneurysmal Subarachnoid Hemorrhage

Interventions

DRUG

Tirofiban

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.

DRUG

Placebo

IV infusion at the same infusion duration as the study drug; same adjustments

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Dr David Hasan, M.D.

    lead OTHER

Principal Investigators

  • Emad Hasan, MD · Duke University

  • Brian Mac Grory, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-23
Primary Completion
2029-01-23
Completion
2032-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07493577 on ClinicalTrials.gov