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Induced Suppression of Platelets Activity in Aneurysmal SAH Management (iSPASM)

NCT03691727 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-01-10

Study results available
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Summary

This is a phase 1/2a, randomized, double blind, single-center study comparing standard care alone to standard care with Aggrastat in patients diagnosed with aneurysmal subarachnoid hemorrhage.

Conditions

  • Subarachnoid Hemorrhage, Aneurysmal

Interventions

DRUG

tirofiban hydrochloride (AGGRASTAT®)

Participants will have intravenous Aggrastat administered continuously over the course of 7 days in the setting of subarachnoid hemorrhage at least 12 hours post clinically indicated Endovascular Coil Embolization procedure.

DIAGNOSTIC_TEST

MRI

Participants will undergo 2 MRIs administered within 24 hours post Coil Embolization procedure and prior to discharge to monitor for ischemic changes.

DIAGNOSTIC_TEST

Neurological Exam

Neurological exams will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.

BEHAVIORAL

Questionnaires

Quality of Life in Brain Injury - Overall Scale (QOLIBRI-OS) and the Lawton Instrumental Activities of Daily Living (IADL) will be administered at 6 month and 1 year follow up visits.

DIAGNOSTIC_TEST

Vital Signs

Vital signs which include temperature, respiration rate, blood pressure and O2 stats will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.

OTHER

Standard of Care Treatment

Participants will receive standard of care treatment and will not receive study drug.

Sponsors & Collaborators

  • David Hasan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-24
Primary Completion
2020-07-01
Completion
2021-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03691727 on ClinicalTrials.gov