Ultra-early STatin in Patients With Aneurysmal subaRachnoid Hemorrhage (Ue-STAR)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atorvastatin.
- Who it may be relevant to
- Registry conditions: Subarachnoid Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal, Aneurysmal Subarachnoid Hemorrhage, Hemorrhage, Aneurysmal Subarachnoid. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ultra-early STatin in Patients With Aneurysmal subaRachnoid Hemorrhage (Ue-STAR): a Randomized Controlled Trial
Overview
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.
Interventions
- Drug Atorvastatin
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
Primary outcome measures
- Utility-Weighted Modified Rankin Scale [Time frame: 6 months after discharge]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- Male or female; Aged ≥18 years
- Signs and symptoms presumed aneurysmal subarachnoid hemorrhage, confirmed by radiological evidence
- Treatment within 6 h after symptom onset
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Medical University General Hospital — Tianjin
Identifiers
NCT: NCT06559072 · IRB2024-YX-167-01