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

September 1, 2024 updated by: The George Institute

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
522

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Tianjin, China
        • Tianjin Medical University General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 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.
Experimental: 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
Drug: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months after discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6 months after discharge
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.
6 months after discharge
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".
6 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The George Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tianjin Medical University General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB2024-YX-167-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After a domain is completed, the archived de-identified limited dataset of randomized participants will be transmitted to and stored in the Data Repository, for use by researchers. Data can be shared after publication of the main results unless specified otherwise in domain-specific registration.

IPD Sharing Time Frame

Open data access within 12 months after the publication of research results

IPD Sharing Access Criteria

Data can be shared after publication of the main results, based on approval of a submitted protocol to the Publication Committee. Data can be shared to bona fide researchers with experience in medical research, and with no conflict of interest that may potentially influence their interpretation of any analyses, and employed by a recognised academic institute, health service organisation, commercial research organisation of from the pharmaceutical industry. The data sharing will be only for analyses within the constraints of the consent under which the data were originally gathered consent.

Data sharing with industry will be according to relevant contracts with appropriate approvals from all stake holders.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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