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

Launched by THE GEORGE INSTITUTE · Aug 14, 2024

Keywords

ClinConnect Summary

The Ue-STAR trial is a research study looking at the effects of a medication called statin when given very early to patients who have experienced a specific type of brain bleeding known as aneurysmal subarachnoid hemorrhage (aSAH). This study aims to find out if taking statins shortly after symptoms start can help improve patient outcomes. The trial will involve multiple hospitals and will include both men and women aged 18 and older who show signs of aSAH and can start treatment within six hours of their symptoms.

To be part of this study, participants should not have had statin medication before their brain bleeding event, and they must not have any serious health issues like severe liver or kidney disease. Additionally, they should not be pregnant or currently involved in other clinical trials. If eligible, participants can expect to receive either the statin treatment or a placebo (a substance with no active medication) and will be monitored closely for safety and effectiveness. This research is an important step in finding better treatments for this serious condition.

Gender

ALL

Eligibility criteria

• 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