Subarachnoid HemorrhagePhase 3Ue-STARNCT06559072
Ultra-early STatin in Patients With Aneurysmal subaRachnoid Hemorrhage (Ue-STAR)
A Phase 3 study testing Atorvastatin in people with Subarachnoid Hemorrhage and Subarachnoid Hemorrhage, Aneurysmal, run by The George Institute at 1 site in China.
Trial summary
A researcher-initiated and conducted multicenter, randomized controlled trial aimed at evaluating the efficacy and safety of ultra-early statin therapy in the treatment of acute aneurysmal subarachnoid hemorrhage (aSAH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal, Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Sep 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Male or female; Aged ≥18 years
- Signs and symptoms presumed aneurysmal subarachnoid hemorrhage, confirmed by radiological evidence
- Treatment within 6 h after symptom onset
Who cannot join
- Treatment with statin prior SAH
- Non-aSAH (e.g. traumatic subarachnoid hemorrhage, arteriovenous malformation)
- Treatment \> 6 h after symptom onset
- Allergy to statin medications or presence of severe adverse reactions such as abnormal liver function or rhabdomyolysis
- Evidence of irreversible brain damage or expected death within 7 days
- Known severe liver or kidney disease
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- Non-compliance with follow-up
- Pregnant or breastfeeding
- History of severe cranial or psychiatric illness
- Concomitant serious systemic disease
- Patients with malignant tumors
- Currently participating in another clinical trial
- Considered unsuitable for the clinical trial by clinical physicians or researchers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultra-early STatin in Patients With Aneurysmal subaRachnoid Hemorrhage (Ue-STAR): a Randomized Controlled Trial
A researcher-initiated and conducted multicenter, randomized controlled trial aimed at evaluating the efficacy and safety of ultra-early statin therapy in the treatment of acute aneurysmal subarachnoid hemorrhage (aSAH).
Read the detailed description
To further explore the efficacy and safety of ultra-early statin administration in aSAH, the investigators propose a Phase III randomized controlled trial-The Ultra-early Statin in patients with Aneurysmal subArachnoid hemorrhage (Ue-STAR) trial. This study aims to determine whether ultra-early (within 6 hours), short-term treatment (2 weeks) with a high intensive long-acting statin (atorvastatin 40 mg/day) improves clinical outcomes at 6 months in aSAH patients. Through this research, the investigators hope to provide more robust evidence for the clinical management of aSAH, ultimately improving treatment outcomes for patients.
- Conditions
- Subarachnoid Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal, Aneurysmal Subarachnoid Hemorrhage, Hemorrhage, Aneurysmal Subarachnoid
- Being tested
- Atorvastatin
- Keywords
- aneurysmal subarachnoid hemorrhage, atorvastatin, Atorvastatin Calcium
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
On the basis of routine treatment for aneurysmal subarachnoid hemorrhage, atorvastatin was administered at an ultra early stage at a dose of 40mg/d for 14 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin group | Experimental | On the basis of routine treatment for aneurysmal subarachnoid hemorrhage, atorvastatin was administered at an ultra early stage at a dose of 40mg/d for 14 consecutive days Receives: Drug: Atorvastatin |
| Conventional treatment group | No intervention | Conventional treatment for aneurysmal subarachnoid hemorrhage typically includes measures such as blood pressure control, hemostasis, reduction of intracranial pressure, prevention of complications, and, when deemed necessary based on the patient's condition, surgical intervention. No specific interventions are applied unless warranted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility-Weighted Modified Rankin Scale
A utility-weighted Modified Rankin Scale (UW-mRS) was derived by averaging values from time-tradeoff (patient centered) and person-tradeoff (clinician centered) studies. Utility values were 1.0 for Modified Rankin Scale (mRS) level 0; 0.91 for mRS level 1; 0.76 for mRS level 2; 0.65 for mRS level 3; 0.33 for mRS level 4; 0 for mRS level 5; and 0 for mRS level 6. Higher scores mean a better outcome.
Measured: 6 months after discharge
Secondary outcomes (3)
Modified Rankin Scale Score
The modified Rankin Scale (mRS) is the most widely used scale to measure the degree of handicap in stroke patients, ranging from 0 (no symptoms) to 6 (dead). Higher scores mean a worse outcome.
Measured: 6 months after discharge
Glasgow Outcome Scale Extended
The Glasgow Outcome Scale Extended (GOS-E) is a clinical assessment tool used to assess outcome after head injury and nontraumatic acute brain insults. GOS-E divides patients' states into the following eight levels: dead, vegetative state, lower seven disability, upper seven disability, lower moderate disability, upper moderate disability, mild disability, lower good recovery, and basic recovery.
Measured: 6 months after discharge
The 5-level EQ-5D version
The 5-level EQ-5D version (EQ-5D-5L) essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled "The best health you can image" and "The worst health you can image".
Measured: 6 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Why it stopped: Funding issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559072
- Sponsor's protocol ID
- IRB2024-YX-167-01
- Acronym
- Ue-STAR
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After a domain is completed, the archived de-identified limited dataset of randomized participants will be transmitted to and stored in the Data Repository, for use by researchers. Data can be shared after publication of the main results unless specified otherwise in domain-specific registration.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-early STatin in Patients With Aneurysmal subaRachnoid Hemorrhage (Ue-STAR): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06559072
- Acronym / sponsor ID
- Ue-STAR / IRB2024-YX-167-01
- Conditions
- Subarachnoid Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal, Aneurysmal Subarachnoid Hemorrhage, Hemorrhage, Aneurysmal Subarachnoid
- Keywords
- aneurysmal subarachnoid hemorrhage, atorvastatin, Atorvastatin Calcium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- Tianjin Medical University General Hospital
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 19 Aug 2024 (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.
A researcher-initiated and conducted multicenter, randomized controlled trial aimed at evaluating the efficacy and safety of ultra-early statin therapy in the treatment of acute aneurysmal subarachnoid hemorrhage (aSAH).
Detailed description
To further explore the efficacy and safety of ultra-early statin administration in aSAH, the investigators propose a Phase III randomized controlled trial-The Ultra-early Statin in patients with Aneurysmal subArachnoid hemorrhage (Ue-STAR) trial. This study aims to determine whether ultra-early (within 6 hours), short-term treatment (2 weeks) with a high intensive long-acting statin (atorvastatin 40 mg/day) improves clinical outcomes at 6 months in aSAH patients. Through this research, the investigators hope to provide more robust evidence for the clinical management of aSAH, ultimately improving treatment outcomes for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin group | Experimental | Drug: AtorvastatinOn the basis of routine treatment for aneurysmal subarachnoid hemorrhage, atorvastatin was administered at an ultra early stage at a dose of 40mg/d for 14 consecutive days |
| Conventional treatment group | No intervention | –Conventional treatment for aneurysmal subarachnoid hemorrhage typically includes measures such as blood pressure control, hemostasis, reduction of intracranial pressure, prevention of complications, and, when deemed necessary based on the patient's condition, surgical intervention. No specific interventions are applied unless warranted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female; Aged ≥18 years
- Signs and symptoms presumed aneurysmal subarachnoid hemorrhage, confirmed by radiological evidence
- Treatment within 6 h after symptom onset
Key exclusion criteria (13 listed)
- Treatment with statin prior SAH
- Non-aSAH (e.g. traumatic subarachnoid hemorrhage, arteriovenous malformation)
- Treatment \> 6 h after symptom onset
- Allergy to statin medications or presence of severe adverse reactions such as abnormal liver function or rhabdomyolysis
- Evidence of irreversible brain damage or expected death within 7 days
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 |
|---|---|---|
| AtorvastatinOn the basis of routine treatment for aneurysmal subarachnoid hemorrhage, atorvastatin was administered at an ultra early stage at a dose of 40mg/d for 14 consecutive days | Drug | Atorvastatin group |
Primary outcome
Utility-Weighted Modified Rankin Scale
Time frame: 6 months after discharge
A utility-weighted Modified Rankin Scale (UW-mRS) was derived by averaging values from time-tradeoff (patient centered) and person-tradeoff (clinician centered) studies. Utility values were 1.0 for Modified Rankin Scale (mRS) level 0; 0.91 for mRS level 1; 0.76 for mRS level 2; 0.65 for mRS level 3; 0.33 for mRS level 4; 0 for mRS level 5; and 0 for mRS level 6. Higher scores mean a better outcome.
3 secondary outcomes
Modified Rankin Scale Score
Time frame: 6 months after discharge
Glasgow Outcome Scale Extended
Time frame: 6 months after discharge
The 5-level EQ-5D version
Time frame: 6 months after discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. After a domain is completed, the archived de-identified limited dataset of randomized participants will be transmitted to and stored in the Data Repository, for use by researchers. Data can be shared after publication of the main results unless specified otherwise in domain-specific registration.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin in people with Subarachnoid Hemorrhage and Subarachnoid Hemorrhage, Aneurysmal, run by The George Institute at 1 site in China.
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 3 inclusion and 13 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: withdrawn, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility-Weighted Modified Rankin Scale (time frame: 6 months after discharge). 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 5 Oct 2026.