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

Phase 3

Not yet recruiting

Conditions: Aneurysmal Subarachnoid Hemorrhage

Registration Number: 2024-516468-27-00

Lead Sponsor: Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience

Brief Summary: Our main objective is to show that 100mg twice a day of cilostazol over 14 days improves the modified Rankin scale at 6-months in aneurysmal SAH treated with nimodipine, against placebo

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 630

Inclusion Criteria

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

Exclusion Criteria

Precritical modified Rankin Scale (mRS) > 2

Non-aneurysmal SAH

Delayed > 96h admission after first symptoms of SAH

Untreatable severe SAH with Hunt and Hess grade of V - Known allergy to cilostazol

Pregnancy

Pre-existing major hepatic, renal, pulmonary or cardiac disease

Concomitant use of one other anti-platelet and/or anticoagulant agent

Tutelage or guardianship

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)		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 Outcome Measures

Name	Time	Method
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).		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		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.		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		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		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 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 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 new cerebral infarcts
Occurrence of cilostazol-related major adverse events, including: arrythmia, abnormal bleeding and allergy.		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.		Occurrence of cilostazol-related minor adverse events include: tachycardia, fever, fainting, nausea, vomiting and stomach pain.

Trial Locations

Locations (9): Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
🇫🇷
Paris, France
Bicetre Hospital
🇫🇷
Le Kremlin Bicetre Cedex, France
Fondation A De Rothschild
🇫🇷
Paris Cedex 19, France
Centre Hospitalier Universitaire De Nantes
🇫🇷
Nantes, France
Hospices Civils De Lyon
🇫🇷
Bron, France
Hospital Foch
🇫🇷
Suresnes, France
Assistance Publique Hopitaux De Paris
🇫🇷
Paris, France
Hopitaux Universitaires Pitie Salpetriere
🇫🇷
Paris, France
Centre Hospitalier Universitaire De Caen Normandie
🇫🇷
Caen Cedex 9, France
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
🇫🇷Paris, France
CAROLINE SCHIMPF
Site contact
0678040578
c.schimpf@ghu-paris.fr