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NCT Number: NCT06559072

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

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).

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Key information

Conditions

Subarachnoid Hemorrhage Aneurysmal Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Hemorrhage, Aneurysmal Subarachnoid Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage, Aneurysmal Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

atorvastatin

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

Primary outcomes

  1. Utility-Weighted Modified Rankin Scale

    Time frame: 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 outcomes

  1. Modified Rankin Scale Score

    Time frame: 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.

  2. Glasgow Outcome Scale Extended

    Time frame: 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.

  3. The 5-level EQ-5D version

    Time frame: 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".

Study contacts

Contact information is provided by the study sponsor or research team.

Rongcai Jiang

CONTACT

[email protected]

+86 136 7211 6556

Tao Liu

CONTACT

[email protected]

61-466068193

Sponsors and collaborators

Lead sponsor

The George Institute

Other

Collaborators

  • Tianjin Medical University General Hospital

Registry information

Official study title

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

Acronym: Ue-STAR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2024
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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