Aneurysmal Subarachnoid Hemorrhage, Hemorrhage, Aneurysmal Subarachnoid, Subarachnoid Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal
Conditions
Keywords
aneurysmal subarachnoid hemorrhage, atorvastatin, Atorvastatin Calcium
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 (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.
Interventions
DRUGAtorvastatin
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
Sponsors
Tianjin Medical University General Hospital
The George Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactRongcai Jiang
Backup ContactTao Liu
Outcome results
None listed