The CASH study is a randomized, double-blind, placebo-controlled trial evaluating whether adding cilostazol to standard nimodipine therapy improves neurological outcomes in patients with aneurysmal subarachnoid hemorrhage (aSAH). The primary objective is to assess functional outcome at 6 months using the modified Rankin Scale. A total of 630 patients will be enrolled within 96 hours of aSAH onset and treated for 14 days. The study is conducted across 9 centers in France, funded by a PHRC, and overseen by an independent monitoring board.
Adult patients admitted to an ICU with SAH related to a ruptured cerebral aneurysm occurring within the last 96 hours.
Aneurysm successfully secured by surgical clipping or endovascular coiling
Consent of the patient or, if not possible, from a proxy (emergency clause).
Registration in a national health care system
- Precritical modified Rankin Scale (mRS) > 2
Nonaneurysmal SAH
Delayed >96h admission after first symptoms of SAH
Coma defined by GCS of 3-5 with untreatable aneurysm will be excluded"
Parallel
Cilostazol (Pletal®) 100 mg Tablets
Biological/Vaccine100 mg orally or via feeding tube twice daily for 14 days, starting within 96 hours after aneurysmal subarachnoid hemorrhage onset. Tablets may be crushed for enteral administration.
Placebo
DrugOral or enteral placebo, visually identical to cilostazol, twice daily for 14 days, starting within 96 hours after hemorrhage onset.
Nimodipine group
DrugAdministered orally, enterally, or intravenously for 21 days as part of standard of care. Dose, route, and duration determined by treating physician according to clinical condition and guidelines.
Modified Rankin Scale (mRS) Score at 6 Months After Aneurysmal Subarachnoid Hemorrhage
Neurological functional outcome will be measured using the modified Rankin Scale (mRS) at 6 months post-aneurysmal subarachnoid hemorrhage. The mRS is a 7-point ordinal scale ranging from 0 (no symptoms) to 6 (death), assessing the degree of disability or dependence in daily activities.
Functional Outcome at 6 Months Measured by the Subarachnoid Hemorrhage Outcome Tool (SAHOT)
SAHOT total score (range: 0-100; higher scores indicate better functional outcome).
In-hospital morbidity and mortality
Length of stay in Intensive Care Unit (ICU) Length of hospital stay 28-day mortality
Clinical and radiological events predictive of functional status
Delayed cerebral ischemia (DCI): focal neurological deficit or a decrease of at least 2 points in the Glasgow Coma Scale, not occurring immediately after aneurysm occlusion and not attributable to other causes. Cerebral vasospasm: reduction in the calibre of proximal cerebral vessels seen on CT angiography, MR angiography, or catheter angiography (DSA), classified according to severity. Cerebral infarcts: diagnosis by CT or MRI scan within 6 weeks (or latest imaging before death within 6 weeks, or at autopsy), not present on the CT or MRI scan performed between 24 and 48 hours after early aneurysm occlusion and not attributable to other causes.
Incidence of Cilostazol-Related Major and Minor Adverse Events
Major adverse events: arrhythmia, abnormal bleeding, allergy. Minor adverse events: tachycardia, fever, fainting, nausea, vomiting, stomach pain. Notes: Data will be collected from patient reports, clinical assessments, and medical records to evaluate the safety and tolerability of cilostazol.
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