NCT06559072

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

Ultra-early STatin in Patients With Aneurysmal subaRachnoid Hemorrhage (Ue-STAR): a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 522 (estimated)
• Sponsor: The George Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-01-01
• Completion: 2026-09-01
• First posted: 2024-08-19
• Last updated: 2024-09-05

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study