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Is adding Cilostazol to nimodipine improving neurological outcome of patients with Aneurysmal Subarachnoid Hemorrhage? A randomized, double blind, placebo-controlled trial

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516468-27-00
Acronym
D24-P009
Enrollment
630
Registered
2025-05-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysmal Subarachnoid Hemorrhage

Brief summary

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)

Detailed description

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)., Other generic morbidity criterion will be used: Length of Intensive Care Unit (ICU) stay. Length of hospital stay. 28-day mortality, 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., 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, 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, Occurrence of DCI during the ICU stay, 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, Occurrence of new cerebral infarcts, Occurrence of cilostazol-related major adverse events, including: arrythmia, abnormal bleeding and allergy., Occurrence of cilostazol-related minor adverse events include: tachycardia, fever, fainting, nausea, vomiting and stomach pain.

Interventions

DRUGCilostazol-Elpen 100 mg Tabletten
DRUGPlacebo de Cilostazol-Elpen 100mg
DRUGcomprimé

Sponsors

Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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)

Secondary

MeasureTime frame
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)., Other generic morbidity criterion will be used: Length of Intensive Care Unit (ICU) stay. Length of hospital stay. 28-day mortality, 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., 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, Cerebral infarctions, defined by a diagnosis

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026