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

NCT ID: NCT06559072

Last Updated: 2024-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

522 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-09-01

Brief Summary

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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

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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

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Subarachnoid Hemorrhage Subarachnoid Hemorrhage, Aneurysmal Aneurysmal Subarachnoid Hemorrhage Hemorrhage, Aneurysmal Subarachnoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Atorvastatin group

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

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

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

Conventional treatment group

Conventional treatment for aneurysmal subarachnoid hemorrhage typically includes measures such as blood pressure control, hemostasis, reduction of intracranial pressure, prevention of complications, and, when deemed necessary based on the patient's condition, surgical intervention. No specific interventions are applied unless warranted.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

The George Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tianjin Medical University General Hospital

Tianjin, , China

Site Status

Countries

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China

Central Contacts

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Rongcai Jiang

Role: CONTACT

+86 136 7211 6556

Tao Liu

Role: CONTACT

61-466068193

Facility Contacts

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Zhihao Zhao

Role: primary

+86 13633627965

Other Identifiers

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IRB2024-YX-167-01

Identifier Type: -

Identifier Source: org_study_id

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