Ultra-early STatin in Patients With Aneurysmal subaRachnoid Hemorrhage (Ue-STAR)

The George Institute

Status and phase: Not yet enrolling; Phase 3

Conditions: Subarachnoid Hemorrhage; Subarachnoid Hemorrhage, Aneurysmal; Aneurysmal Subarachnoid Hemorrhage; Hemorrhage, Aneurysmal Subarachnoid

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT06559072

IRB2024-YX-167-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 522 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female; Aged ≥18 years
2. Signs and symptoms presumed aneurysmal subarachnoid hemorrhage, confirmed by radiological evidence
3. Treatment within 6 h after symptom onset

Exclusion criteria

1. Treatment with statin prior SAH
2. Non-aSAH (e.g. traumatic subarachnoid hemorrhage, arteriovenous malformation)
3. Treatment > 6 h after symptom onset
4. Allergy to statin medications or presence of severe adverse reactions such as abnormal liver function or rhabdomyolysis
5. Evidence of irreversible brain damage or expected death within 7 days
6. Known severe liver or kidney disease
7. Non-compliance with follow-up
8. Pregnant or breastfeeding
9. History of severe cranial or psychiatric illness
10. Concomitant serious systemic disease
11. Patients with malignant tumors
12. Currently participating in another clinical trial
13. Considered unsuitable for the clinical trial by clinical physicians or researchers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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522 participants in 2 patient groups

Atorvastatin group

Experimental group

Description:

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

Treatment:

Drug: Atorvastatin

Conventional treatment group

No Intervention group

Description:

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.