Aneurysmal Subarachnoid HemorrhagePhase 3CASHNCT07144956
Cilostazol With Nimodipine to Improve Outcome After Aneurysmal Subarachnoid Hemorrhage
A Phase 3 study testing Cilostazol (Pletal®) 100 mg Tablets and Nimodipine group in people with Aneurysmal Subarachnoid Hemorrhage, run by Centre Hospitalier St Anne.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Cilostazol (Pletal®) 100 mg Tablets and Nimodipine group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 630 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 14 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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"
- Known allergy to cilostazol
- Pregnancy
Show all 10Show fewer
- Pre-existing major hepatic, renal, pulmonary or cardiac disease
- Concomitant use of one other anti-platelet and/or anticoagulant agent
- SAH diagnosed on Lumbar puncture with no evidence of blood on CT.
- Tutelage or guardianship
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Is Adding Cilostazol to Nimodipine Improving Neurological Outcome of Patients With Aneurysmal Subarachnoid Hemorrhage? A Randomized, Double Blind, Placebo-controlled Trial
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.
Read the detailed description
The CASH trial (Cilostazol in Aneurysmal Subarachnoid Hemorrhage) is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial investigating whether the addition of cilostazol to standard nimodipine therapy improves long-term neurological outcomes in patients suffering from aneurysmal subarachnoid hemorrhage (aSAH).
Secondary brain injury following aSAH, particularly delayed cerebral ischemia (DCI) and vasospasm, remains a major cause of mortality and long-term disability. Currently, nimodipine is the only drug with proven efficacy in improving neurological outcomes after aSAH. However, emerging data-mostly from studies conducted in Japan-suggest that cilostazol, a selective phosphodiesterase 3 (PDE3) inhibitor with antiplatelet and vasodilatory effects, may further reduce the risk of ischemic complications and disability when added to standard care.
The cilostazol mechanism includes inhibition of platelet aggregation via cAMP enhancement, vasodilation via nitric oxide release, and endothelial protection. Experimental studies also suggest neuroprotective effects such as attenuation of cortical spreading depolarizations and inhibition of vascular smooth muscle cell proliferation.
The trial will enroll 630 adult patients admitted to intensive care units within 96 hours of a confirmed aSAH due to a ruptured aneurysm that has been secured by either surgical clipping or endovascular coiling. Patients will be randomly assigned to receive either cilostazol 100 mg twice daily for 14 days (administered orally or via gastric tube) or placebo, alongside the standard 21-day nimodipine regimen.
The primary endpoint is the neurological outcome at 6 months, assessed by the modified Rankin Scale (mRS). Secondary outcomes include cognitive performance (MoCA score), return to work, independence in daily activities, hospital and ICU stay durations, 28-day mortality, and incidence of DCI, vasospasm, and cerebral infarctions as defined by imaging or clinical criteria.
The study will be conducted over 49 months (42 months of enrollment + 6 months of follow-up), across 9 French centers, with an expected inclusion rate of 1.9 patients per center per month. Two interim analyses are planned. The study is funded by a Programme Hospitalier de Recherche Clinique (PHRC) and monitored by an independent data safety monitoring board (DSMB).
While cilostazol is generally well tolerated, especially in short-term use, potential side effects include headache, palpitations, diarrhea, arrhythmias, bleeding, and allergic reactions. Previous short-term studies suggest an acceptable safety profile in aSAH patients.
If positive, the CASH study may significantly impact clinical guidelines by supporting the inclusion of cilostazol as an adjunct therapy in the management of aneurysmal subarachnoid hemorrhage.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- Cilostazol (Pletal®) 100 mg Tablets, Placebo, Nimodipine group
- Keywords
- Cilostazol, Nimodipine, Vasospasm, Modified Rankin Scale (mRS), Neurological outcome, Double-blind, Randomized Controlled Trial, Multicenter clinical trial
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostazol (Pletal®) 100 mg TabletsBiological
100 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.
PlaceboDrug
Also called Placebo (matching Cilostazol)
Oral or enteral placebo, visually identical to cilostazol, twice daily for 14 days, starting within 96 hours after hemorrhage onset.
Nimodipine groupDrug
Administered 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.
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol + Nimodipine | Experimental | In the cilostazol arm, patients will receive standard care for aneurysmal subarachnoid hemorrhage, including nimodipine administration as recommended by French and European guidelines for delayed cerebral ischemia (DCI) prevention. In addition, participants will receive cilostazol 100 mg twice daily, administered orally or via gastric tube if swallowing is not possible, for 14 consecutive days, starting within 96 hours of hemorrhage onset. Cilostazol tablets may be crushed for enteral administration. All other preventive and curative treatments for vasospasm or DCI-such as hypertensive therapy, milrinone, or endovascular interventions-are permitted at the discretion of the treating physician. Monitoring will include clinical status, occurrence of vasospasm, DCI, cerebral infarction, and cilostazol-related adverse events. Follow-up visits and safety assessments will be identical to the placebo arm. Receives: Biological: Cilostazol (Pletal®) 100 mg Tablets; Drug: Nimodipine group |
| Nimodipine + Placebo | Placebo comparator | In the placebo arm, patients will receive standard care for aneurysmal subarachnoid hemorrhage, which must include nimodipine for the prevention of delayed cerebral ischemia (DCI) as per French and European guidelines. Nimodipine will be administered orally/enterally or intravenously, with dose, route, and duration decided by the treating physician according to patient status and local practice. Participants will receive a placebo, visually identical to cilostazol tablets, given orally or via gastric tube twice daily for 14 days, starting within 96 hours of hemorrhage onset. All other preventive or curative treatments for vasospasm or DCI-such as hypertensive therapy, milrinone, or endovascular procedures-are allowed at the physician's discretion. Monitoring, follow-up, and safety assessments will be performed in the same manner as in the experimental arm. Receives: Drug: Placebo; Drug: Nimodipine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months after aneurysmal subarachnoid hemorrhage
Secondary outcomes (8)
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).
Measured: 6 months
In-hospital morbidity and mortality
Length of stay in Intensive Care Unit (ICU) Length of hospital stay 28-day mortality
Measured: 28 days
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.
Measured: 6 months
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.
Measured: 6 months.
Cognitive Function at 6 Months Measured by the Montreal Cognitive Assessment (MoCA)
MoCA total score (range: 0-30; higher scores indicate better cognitive function).
Measured: 6 months
Return to Work at 6 Months
Number of participants who have returned to work (yes/no).
Measured: 6 months
Activities of Daily Living (ADL) at 6 Months
Independence in basic self-care activities (scored as dependent/independent).
Measured: 6 months
Instrumental Activities of Daily Living (IADL) at 6 Months
Independence in instrumental daily activities (scored as dependent/independent).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start15 Dec 2025 (estimated)
- Primary completion14 Dec 2029 (estimated)
- Study completion14 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The CASH study is a phase III, multicenter, randomized, double-blind, placebo-controlled clinical trial with a parallel-group, adaptive sequential design. Adult patients admitted to intensive care within 96 hours of an aneurysmal subarachnoid hemorrhage (aSAH), and after successful aneurysm securing (clipping or coiling), are randomized into two groups. The experimental group receives cilostazol (100 mg twice daily for 14 days) in addition to standard nimodipine (21 days), while the control group receives placebo plus nimodipine. The primary objective is to assess neurological outcome at 6 months using the modified Rankin Scale. The total study duration is 49 months, including 42 months of enrollment and 6 months of follow-up. Two interim analyses are planned. The study is funded by a PHRC and monitored by an independent Data Safety Monitoring Board (DSMB).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline SCHIMPF, Doctor, Study chair, Chef de service Anesthésie - Réanimation GHU Paris - Neuro Sainte-AnneAurélien MAZERAUD, DOCTOR, Principal investigator, Anesthésie - Réanimation GHU Paris - Neuro Sainte-Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144956
- Sponsor's protocol ID
- D24-009
- Other IDs
- 2024-516468-27-00
- Acronym
- CASH
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be used exclusively for the analyses planned in the protocol and will not be shared outside the study investigators.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Adding Cilostazol to Nimodipine Improving Neurological Outcome of Patients With Aneurysmal Subarachnoid Hemorrhage? A Randomized, Double Blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07144956
- Acronym / sponsor ID
- CASH / D24-009
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Keywords
- Cilostazol, Nimodipine, Vasospasm, Modified Rankin Scale (mRS), Neurological outcome, Double-blind, Randomized Controlled Trial, Multicenter clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 14 Dec 2029 (estimated)
- Study completion
- 14 Dec 2029 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The CASH trial (Cilostazol in Aneurysmal Subarachnoid Hemorrhage) is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial investigating whether the addition of cilostazol to standard nimodipine therapy improves long-term neurological outcomes in patients suffering from aneurysmal subarachnoid hemorrhage (aSAH).
Secondary brain injury following aSAH, particularly delayed cerebral ischemia (DCI) and vasospasm, remains a major cause of mortality and long-term disability. Currently, nimodipine is the only drug with proven efficacy in improving neurological outcomes after aSAH. However, emerging data-mostly from studies conducted in Japan-suggest that cilostazol, a selective phosphodiesterase 3 (PDE3) inhibitor with antiplatelet and vasodilatory effects, may further reduce the risk of ischemic complications and disability when added to standard care.
The cilostazol mechanism includes inhibition of platelet aggregation via cAMP enhancement, vasodilation via nitric oxide release, and endothelial protection. Experimental studies also suggest neuroprotective effects such as attenuation of cortical spreading depolarizations and inhibition of vascular smooth muscle cell proliferation.
The trial will enroll 630 adult patients admitted to intensive care units within 96 hours of a confirmed aSAH due to a ruptured aneurysm that has been secured by either surgical clipping or endovascular coiling. Patients will be randomly assigned to receive either cilostazol 100 mg twice daily for 14 days (administered orally or via gastric tube) or placebo, alongside the standard 21-day nimodipine regimen.
The primary endpoint is the neurological outcome at 6 months, assessed by the modified Rankin Scale (mRS). Secondary outcomes include cognitive performance (MoCA score), return to work, independence in daily activities, hospital and ICU stay durations, 28-day mortality, and incidence of DCI, vasospasm, and cerebral infarctions as defined by imaging or clinical criteria.
The study will be conducted over 49 months (42 months of enrollment + 6 months of follow-up), across 9 French centers, with an expected inclusion rate of 1.9 patients per center per month. Two interim analyses are planned. The study is funded by a Programme Hospitalier de Recherche Clinique (PHRC) and monitored by an independent data safety monitoring board (DSMB).
While cilostazol is generally well tolerated, especially in short-term use, potential side effects include headache, palpitations, diarrhea, arrhythmias, bleeding, and allergic reactions. Previous short-term studies suggest an acceptable safety profile in aSAH patients.
If positive, the CASH study may significantly impact clinical guidelines by supporting the inclusion of cilostazol as an adjunct therapy in the management of aneurysmal subarachnoid hemorrhage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The CASH study is a phase III, multicenter, randomized, double-blind, placebo-controlled clinical trial with a parallel-group, adaptive sequential design. Adult patients admitted to intensive care within 96 hours of an aneurysmal subarachnoid hemorrhage (aSAH), and after successful aneurysm securing (clipping or coiling), are randomized into two groups. The experimental group receives cilostazol (100 mg twice daily for 14 days) in addition to standard nimodipine (21 days), while the control group receives placebo plus nimodipine. The primary objective is to assess neurological outcome at 6 months using the modified Rankin Scale. The total study duration is 49 months, including 42 months of enrollment and 6 months of follow-up. Two interim analyses are planned. The study is funded by a PHRC and monitored by an independent Data Safety Monitoring Board (DSMB).
| Arm | Type | Receives |
|---|---|---|
| Cilostazol + Nimodipine | Experimental | Biological: Cilostazol (Pletal®) 100 mg Tablets, Drug: Nimodipine groupIn the cilostazol arm, patients will receive standard care for aneurysmal subarachnoid hemorrhage, including nimodipine administration as recommended by French and European guidelines for delayed cerebral ischemia (DCI) prevention. In addition, participants will receive cilostazol 100 mg twice daily, administered orally or via gastric tube if swallowing is not possible, for 14 consecutive days, starting within 96 hours of hemorrhage onset. Cilostazol tablets may be crushed for enteral administration. All other preventive and curative treatments for vasospasm or DCI-such as hypertensive therapy, milrinone, or endovascular interventions-are permitted at the discretion of the treating physician. Monitoring will include clinical status, occurrence of vasospasm, DCI, cerebral infarction, and cilostazol-related adverse events. Follow-up visits and safety assessments will be identical to the placebo arm. |
| Nimodipine + Placebo | Placebo comparator | Drug: Placebo, Drug: Nimodipine groupIn the placebo arm, patients will receive standard care for aneurysmal subarachnoid hemorrhage, which must include nimodipine for the prevention of delayed cerebral ischemia (DCI) as per French and European guidelines. Nimodipine will be administered orally/enterally or intravenously, with dose, route, and duration decided by the treating physician according to patient status and local practice. Participants will receive a placebo, visually identical to cilostazol tablets, given orally or via gastric tube twice daily for 14 days, starting within 96 hours of hemorrhage onset. All other preventive or curative treatments for vasospasm or DCI-such as hypertensive therapy, milrinone, or endovascular procedures-are allowed at the physician's discretion. Monitoring, follow-up, and safety assessments will be performed in the same manner as in the experimental arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- - 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"
- Known allergy to cilostazol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cilostazol (Pletal®) 100 mg Tablets100 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. | Biological | Cilostazol + Nimodipine |
| PlaceboAlso: Placebo (matching Cilostazol)Oral or enteral placebo, visually identical to cilostazol, twice daily for 14 days, starting within 96 hours after hemorrhage onset. | Drug | Nimodipine + Placebo |
| Nimodipine groupAdministered 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. | Drug | Cilostazol + Nimodipine, Nimodipine + Placebo |
Primary outcome
Modified Rankin Scale (mRS) Score at 6 Months After Aneurysmal Subarachnoid Hemorrhage
Time frame: 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.
8 secondary outcomes
Functional Outcome at 6 Months Measured by the Subarachnoid Hemorrhage Outcome Tool (SAHOT)
Time frame: 6 months
In-hospital morbidity and mortality
Time frame: 28 days
Clinical and radiological events predictive of functional status
Time frame: 6 months
Incidence of Cilostazol-Related Major and Minor Adverse Events
Time frame: 6 months.
Cognitive Function at 6 Months Measured by the Montreal Cognitive Assessment (MoCA)
Time frame: 6 months
Return to Work at 6 Months
Time frame: 6 months
Activities of Daily Living (ADL) at 6 Months
Time frame: 6 months
Instrumental Activities of Daily Living (IADL) at 6 Months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No. The data will be used exclusively for the analyses planned in the protocol and will not be shared outside the study investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline SCHIMPF, Doctor study chair
Chef de service Anesthésie - Réanimation GHU Paris - Neuro Sainte-Anne
Aurélien MAZERAUD, DOCTOR principal investigator
Anesthésie - Réanimation GHU Paris - Neuro Sainte-Anne
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cilostazol (Pletal®) 100 mg Tablets and Nimodipine group in people with Aneurysmal Subarachnoid Hemorrhage, run by Centre Hospitalier St Anne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khaoussou SYLLA, DR (01.45.65.76.78 ext. +33, K.SYLLA@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) Score at 6 Months After Aneurysmal Subarachnoid Hemorrhage (time frame: At 6 months after aneurysmal subarachnoid hemorrhage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.