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

Phase 3

Not yet recruiting

• Conditions: Subarachnoid Hemorrhage; Subarachnoid Hemorrhage, Aneurysmal; Aneurysmal Subarachnoid Hemorrhage; Hemorrhage, Aneurysmal Subarachnoid
• Interventions: Drug: Atorvastatin

• Registration Number: NCT06559072
• Lead Sponsor: The George Institute

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 subarachnoid hemorrhage

Detailed Description

To further explore the efficacy and safety of ultra-early statin administration in aSAH, we 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, we hope to provide more robust evidence for the clinical management of aSAH, ultimately improving treatment outcomes for patients.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-14
• Last Update Submitted: 2024-08-14
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-19
• Study Start: 2024-09-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 522

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin group	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

Name	Time	Method
Utility-Weighted Modified Rankin Scale	6 months after discharge	A utility-weighted Modified Rankin Scale (UW-mRS) was derived by averaging values from time-tradeoff (patient centered) and person-tradeoff (clinician centered) studies. Utility values were 1.0 for Modified Rankin Scale (mRS) level 0; 0.91 for mRS level 1; 0.76 for mRS level 2; 0.65 for mRS level 3; 0.33 for mRS level 4; 0 for mRS level 5; and 0 for mRS level 6. Higher scores mean a better outcome.

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale Score	6 months after discharge	The modified Rankin Scale (mRS) is the most widely used scale to measure the degree of handicap in stroke patients, ranging from 0 (no symptoms) to 6 (dead). Higher scores mean a worse outcome.
The 5-level EQ-5D version	6 months after discharge	The 5-level EQ-5D version (EQ-5D-5L) essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled "The best health you can image" and "The worst health you can image".
Glasgow Outcome Scale Extended	6 months after discharge	The Glasgow Outcome Scale Extended (GOS-E) is a clinical assessment tool used to assess outcome after head injury and nontraumatic acute brain insults. GOS-E divides patients' states into the following eight levels: dead, vegetative state, lower seven disability, upper seven disability, lower moderate disability, upper moderate disability, mild disability, lower good recovery, and basic recovery.

Trial Locations

Locations (1)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, China