Status:
NOT_YET_RECRUITING
Ultra-early STatin in Patients With Aneurysmal subaRachnoid Hemorrhage (Ue-STAR)
Lead Sponsor:
The George Institute
Collaborating Sponsors:
Tianjin Medical University General Hospital
Conditions:
Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 subarachnoi...
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 Aneur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
522 Patients enrolled
Trial Details
Trial ID
NCT06559072
Start Date
September 1 2024
End Date
September 1 2026
Last Update
September 5 2024
Active Locations (1)
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1
Tianjin Medical University General Hospital
Tianjin, China