Comparison · NCT03691727-sae
Tirofiban Hydrochloride (AGGRASTAT®) vs Standard of Care Control Arm: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Tirofiban Hydrochloride (AGGRASTAT®) vs Standard of Care Control Arm: serious adverse events. Trial comparisons, record NCT03691727-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03691727-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 1 | 0.824 | 1 | wilson | |
| Risk in group 2 | 1 | 0.758 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.176 | 0.242 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Tirofiban Hydrochloride (AGGRASTAT®) | tirofiban hydrochloride (AGGRASTAT®) administered continuously over the course of 7 days.~MRI Neurological Exam Vital Signs Questionnaires~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.~MRI: Participants will undergo 2 MRIs administered within 24 hours post Coil Embolization procedure and prior to discharge to monitor for ischemic changes.~Neurological Exam: Neurological exams will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.~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.~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. | 18 | 18 | EG000 |
| Group 2 | Standard of Care Control Arm | Standard of Care Treatment MRI Neurological Exam Vital Signs Questionnaires~MRI: Participants will undergo 2 MRIs administered within 24 hours post Coil Embolization procedure and prior to discharge to monitor for ischemic changes.~Neurological Exam: Neurological exams will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.~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.~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.~Standard of Care Treatment: Participants will receive standard of care treatment and will not receive study drug. | 12 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Enrollment to 1 year follow up appointment (+/- 1 month from enrollment)
Source ClinicalTrials.gov
Trial
- Title
- Induced Suppression of Platelets Activity in Aneurysmal SAH Management (iSPASM)
- NCT number
- NCT03691727
- Phases
- PHASE1, PHASE2
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Interventions
- tirofiban hydrochloride (AGGRASTAT®), MRI, Neurological Exam, Questionnaires, Vital Signs, Standard of Care Treatment
- Lead sponsor
- David Hasan
- Results first posted
- 2021-10-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03691727?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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