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NCT03691727

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

Completed Phase 1, PHASE2 Results posted Last updated 10 January 2022
What this trial tests

Phase 1, PHASE2 trial testing tirofiban hydrochloride (AGGRASTAT®) in Subarachnoid Hemorrhage, Aneurysmal in 30 participants. Completed in 1 July 2021.

Timeline
24 January 2019
Primary endpoint
1 July 2020
1 July 2021

Quick facts

Lead sponsorDavid Hasan
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment30
Start date24 January 2019
Primary completion1 July 2020
Estimated completion1 July 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

David Hasan — full company profile →

Who can join

Adults 18 to 85, any sex, with Subarachnoid Hemorrhage, Aneurysmal. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Intracranial Hemorrhage (Symptomatic and Asymptomatic) Primary · Day 1 to Day 7

The hypothesis is that the prevalence of intracranial hemorrhage (symptomatic and asymptomatic) secondary to ventriculostomy/VPS placement during the course of Aggrastat use is within 10% difference when compared to control using Day 1 and Day 7 non-contrast head CT to determine.

GroupValue95% CI
Tirofiban Hydrochloride (AGGRASTAT®)2
Standard of Care Control Arm1
Number of Participants With Delayed Cerebral Ischemia /Clinical Vasospasm Primary · Day 1 to Day 7

The measurement of then incidence of delayed cerebral ischemia /clinical vasospasm in Tirofiban/Aggrastat group vs. placebo

GroupValue95% CI
Tirofiban Hydrochloride (AGGRASTAT®)1
Standard of Care Control Arm4

Adverse events — posted to ClinicalTrials.gov

Time frame: Enrollment to 1 year follow up appointment (+/- 1 month from enrollment). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tirofiban Hydrochloride (AGGRASTAT®)
Serious: 18/18 (100%)
Deaths: 1/18
Standard of Care Control Arm
Serious: 12/12 (100%)
Deaths: 0/12

Serious adverse events (23 terms)

ReactionSystemTirofiban Hydrochloride (A…Standard of Care Control Arm
Clinical VasospasmNervous system disorders
HypotensionCardiac disorders
Acute Hypoxic Respiratory FailureRespiratory, thoracic and mediastinal disorders
Deep Vein Thrombosis (DVT)Vascular disorders
PneumoniaInfections and infestations
Atrial fibrillation with rapid ventricular responseCardiac disorders
Radiographic VasospasmNervous system disorders
Cerebral EdemaNervous system disorders
External Ventricular Drain (EVD) MalfunctionProduct Issues
ThrombocytopeniaBlood and lymphatic system disorders
VentriculitisNervous system disorders
EncephalopathyNervous system disorders
Enterocolitis InfectiousInfections and infestations
Atrial FibrillationCardiac disorders
Frontal Lobe IschemiaNervous system disorders
IleusNervous system disorders
Intracranial HypertensionNervous system disorders
Intracranial Hypertension with Cerebral EdemaNervous system disorders
Neurogenic Pulmonary EdemaNervous system disorders
Parietal Punctate InfarctsNervous system disorders
Subdural HematomaNervous system disorders
Suicidal IdeationPsychiatric disorders
Vasogenic EdemaBlood and lymphatic system disorders
Other adverse events (52 terms — click to expand)

ReactionSystemTirofiban Hydrochloride (A…Standard of Care Control Arm
FeverInfections and infestations
Low HemoglobinBlood and lymphatic system disorders
Low PotassiumRenal and urinary disorders
Low SodiumRenal and urinary disorders
High White Blood Cell (WBC) CountBlood and lymphatic system disorders
Low HematocritBlood and lymphatic system disorders
PolyuriaRenal and urinary disorders
High Platelet CountBlood and lymphatic system disorders
Low Creatinine LevelRenal and urinary disorders
Urinary RetentionRenal and urinary disorders
DiarrheaMetabolism and nutrition disorders
TachycardiaCardiac disorders
HeadacheNervous system disorders
AgitationPsychiatric disorders
DeliriumPsychiatric disorders
Cerebral Salt Wasting PhenomenonNervous system disorders
ConstipationGastrointestinal disorders
DysphagiaGastrointestinal disorders
NauseaGastrointestinal disorders
SomnolenceNervous system disorders
Altered Mental StatusPsychiatric disorders
Urinary Tract Infection (UTI)Immune system disorders
Back PainGeneral disorders
BigeminyCardiac disorders
Electrocardiogram (EKG) ChangesCardiac disorders
Hip PainGeneral disorders
HypertensionCardiac disorders
Neck PainMusculoskeletal and connective tissue disorders
Abdominal PainGastrointestinal disorders
BradycardiaCardiac disorders
External Ventricular Drain MalfunctionProduct Issues
IleusGastrointestinal disorders
Acute Hypoxic Respiratory FailureRespiratory, thoracic and mediastinal disorders
AnxietyPsychiatric disorders
Decreased AppetiteMetabolism and nutrition disorders
DysphasiaGeneral disorders
Ear PainGeneral disorders
Flank PainGeneral disorders
Groin Yeast InfectionInfections and infestations
High Glucose LevelEndocrine disorders

Most-reported serious reactions: Clinical Vasospasm, Hypotension, Acute Hypoxic Respiratory Failure, Deep Vein Thrombosis (DVT), Pneumonia, Atrial fibrillation with rapid ventricular response, Radiographic Vasospasm, Cerebral Edema.

Data from ClinicalTrials.gov NCT03691727 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Contemporary management of aneurysmal subarachnoid haemorrhage. An update for the intensivist.
    Robba C, Busl KM, Claassen J, Diringer MN, et al · · 2024 · cited 66× · PMID 38598130 · DOI 10.1007/s00134-024-07387-7
  2. Safety of tirofiban and dual antiplatelet therapy in treating intracranial aneurysms.
    Samaniego EA, Gibson E, Nakagawa D, Ortega-Gutierrez S, et al · · 2019 · cited 44× · PMID 31105977 · DOI 10.1136/svn-2018-000192
  3. Phase 1/2a Trial of ISPASM.
    Zanaty M, Allan L, Samaniego EA, Piscopo A, et al · · 2021 · cited 13× · PMID 34470496 · DOI 10.1161/strokeaha.121.034578
  4. Pathophysiological mechanisms underlying early brain injury and delayed cerebral ischemia in the aftermath of aneurysmal subarachnoid hemorrhage: a comprehensive analysis.
    Stragier H, Vandersmissen H, Ordies S, Thiessen S, et al · · 2025 · cited 7× · PMID 40488203 · DOI 10.3389/fneur.2025.1587091

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