CILOSTAZOL for Aneurysmal subarachnoid hemorrhage

Inclusion criteria

• {"criterion_text":"- Adult patients admitted to an ICU with SAH related to a ruptured cerebral aneurysm occurring within the last 96 hours.\n- Aneurysm successfully secured by surgical clipping or endovascular coiling\n- Consent of the patient or, if not possible, from a proxy (emergency clause).\n- Registration in a national health care system"}

Exclusion criteria

• {"criterion_text":"- Precritical modified Rankin Scale (mRS) > 2\n- Non-aneurysmal SAH\n- Delayed > 96h admission after first symptoms of SAH\n- Untreatable severe SAH with Hunt and Hess grade of V - Known allergy to cilostazol\n- Pregnancy\n- Pre-existing major hepatic, renal, pulmonary or cardiac disease\n- Concomitant use of one other anti-platelet and/or anticoagulant agent\n- Tutelage or guardianship"}

Primary endpoints

• {"endpoint_text":"- Modified Rankin Scale (mRS) assessed at 6 months in a structured face-to-face interview. Favorable outcome is defined by an mRS score 0 to 2, and unfavorable outcome by a mRS from 3 to 6. (Appendix 1)","definition_or_measurement_approach":"mRS assessed at 6 months in a structured face-to-face interview; favorable outcome defined as mRS 0-2, unfavorable outcome mRS 3-6."}

Secondary endpoints

• {"endpoint_text":"- The main pitfall of the modified Rankin Scale is the overrating of patients that develop cognitive impairment. We thus chose to assess separately cognitive impairment with using specific scales, including the MOCA, ADL and IADL. The SAHOT (SAH-outcome tool) will be finally assessed, as it has been recently developed and validated but not yet commonly used as the mRS (18).","definition_or_measurement_approach":"Assessment of cognitive impairment using MOCA, ADL, IADL and SAHOT as separate measures of functional/cognitive outcome."}
• {"endpoint_text":"- Other generic morbidity criterion will be used: Length of Intensive Care Unit (ICU) stay. Length of hospital stay. 28-day mortality","definition_or_measurement_approach":"Length of ICU stay and hospital stay measured in days; 28-day mortality assessed as death within 28 days."}
• {"endpoint_text":"- Delayed cerebral ischemia, defined by the appearance of a focal neurological deficit or a decrease of at least 2 points on the Glasgow Coma Scale, which is not apparent immediately after surgical or endovascular treatment of the aneurysm and not attributable to other causes.","definition_or_measurement_approach":"DCI defined as new focal neurological deficit or ≥2 point decrease in Glasgow Coma Scale not immediate after aneurysm treatment and not attributable to other causes."}
• {"endpoint_text":"- Short-term course of angiographically defined vasospasm, defined as a reduction in the caliber of proximal cerebral vessels observed by CT, MRI, or catheter angiography","definition_or_measurement_approach":"Angiographic vasospasm defined as reduction in caliber of proximal cerebral vessels on CT, MR or catheter angiography."}
• {"endpoint_text":"- Cerebral infarctions, defined by a diagnosis of cerebral infarction made by CT scan or MRI within 6 weeks, or on the last CT scan or MRI performed before death within 6 weeks, or at autopsy, not present on the CT scan or MRI between 24 and 48 hours after early aneurysm occlusion","definition_or_measurement_approach":"Cerebral infarction diagnosed by CT or MRI within 6 weeks (or last scan before death within 6 weeks or autopsy) and absent on earlier 24-48 h post-occlusion scan."}
• {"endpoint_text":"- Occurrence of DCI during the ICU stay","definition_or_measurement_approach":"Occurrence of delayed cerebral ischemia recorded during ICU stay based on clinical and imaging criteria."}
• {"endpoint_text":"- Occurrence of cerebral vasospasm on a brain imaging on digitally substracted angiography (DSA) or Magnetic resonance/computed tomography angiogram (MR/CTA) performed upon clinical signs of delayed cerebral ischemia or severe impairment of cerebral blood velocity in transcranial doppler","definition_or_measurement_approach":"Occurrence of vasospasm on DSA or MR/CTA prompted by clinical signs of DCI or severe TCD velocity impairment."}
• {"endpoint_text":"- Occurrence of new cerebral infarcts","definition_or_measurement_approach":"New cerebral infarcts identified on imaging post-randomization as specified."}
• {"endpoint_text":"- Occurrence of cilostazol-related major adverse events, including: arrythmia, abnormal bleeding and allergy.","definition_or_measurement_approach":"Major adverse events related to cilostazol including arrhythmia, abnormal bleeding and allergy as recorded in safety monitoring."}
• {"endpoint_text":"- Occurrence of cilostazol-related minor adverse events include: tachycardia, fever, fainting, nausea, vomiting and stomach pain.","definition_or_measurement_approach":"Minor adverse events related to cilostazol including tachycardia, fever, fainting, nausea, vomiting and stomach pain as recorded in safety monitoring."}

France

Earliest CTIS Part Ii Submission Date

26-03-2025

Latest Decision Or Authorization Date

08-12-2025

Processing Time Days

257

Number Of Sites

9

Number Of Participants

630

Primary sponsor

Full Name

Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"DGOS","duties_or_roles":"Source of monetary support","organisation_type":""}