Ultra-early STatin in Patients With Aneurysmal subaRachnoid Hemorrhage (Ue-STAR)
Ue-STAR
1 other identifier
interventional
522
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2024
CompletedFirst Posted
Study publicly available on registry
August 19, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedSeptember 5, 2024
September 1, 2024
1.3 years
August 14, 2024
September 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months after discharge
Secondary Outcomes (3)
Modified Rankin Scale Score
6 months after discharge
Glasgow Outcome Scale Extended
6 months after discharge
The 5-level EQ-5D version
6 months after discharge
Study Arms (2)
Atorvastatin group
EXPERIMENTALOn 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 INTERVENTIONConventional 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Male or female; Aged ≥18 years
- Signs and symptoms presumed aneurysmal subarachnoid hemorrhage, confirmed by radiological evidence
- Treatment within 6 h after symptom onset
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The George Institutelead
- Tianjin Medical University General Hospitalcollaborator
Study Sites (1)
Tianjin Medical University General Hospital
Tianjin, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2024
First Posted
August 19, 2024
Study Start
September 1, 2024
Primary Completion
January 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
September 5, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Open data access within 12 months after the publication of research results
- Access Criteria
- Data can be shared after publication of the main results, based on approval of a submitted protocol to the Publication Committee. Data can be shared to bona fide researchers with experience in medical research, and with no conflict of interest that may potentially influence their interpretation of any analyses, and employed by a recognised academic institute, health service organisation, commercial research organisation of from the pharmaceutical industry. The data sharing will be only for analyses within the constraints of the consent under which the data were originally gathered consent. Data sharing with industry will be according to relevant contracts with appropriate approvals from all stake holders.
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.