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HMG-CoA reductase inhibitor

Statins After Stroke (SATURN Trial)

Phase 3

Recruiting

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 50 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 months

Awards & highlights

SATURN Trial Summary

This trial will help determine if it's better to continue or discontinue statin drugs after suffering from a spontaneous lobar intracerebral hemorrhage, and whether an individual's Apolipoprotein-E genotype should influence this decision.

Who is the study for?

This trial is for individuals aged 50 or older who experienced a type of stroke called spontaneous lobar intracerebral hemorrhage (ICH), were taking statins at the time, and can decide within 7 days to continue or stop their statin medication. It's not for those with severe dementia, high ICH scores, recent heart issues, certain muscle/liver conditions, familial cholesterol problems, drug/alcohol dependency, other serious health issues or women who could become pregnant.Check my eligibility

What is being tested?

The SATURN trial is testing whether patients with ICH should keep taking statins or stop them. It also looks into how an individual's APOE genotype might influence this decision. Part of the study includes MRI scans to see how these choices affect brain markers related to small vessel disease and risk of another ICH.See study design

What are the potential side effects?

While specific side effects are not listed here, generally speaking, statins can cause muscle pain or weakness (myopathy), liver enzyme changes indicating potential liver damage and increased blood sugar levels which may lead to diabetes.

SATURN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 50 years old or older.

SATURN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recurrent symptomatic ICH

Secondary outcome measures

Major Adverse Cerebro- and Cardio-Vascular Events

SATURN Trial Design

2Treatment groups

Active Control

Group I: No-statinActive Control1 Intervention

Subjects will discontinue the statin agent that they were taking at the time of ICH onset. No placebo will be prescribed for these subjects.

Group II: StatinActive Control1 Intervention

The same statin agent and dose that subjects were using at the time of ICH onset.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

836 Previous Clinical Trials

13,008,774 Total Patients Enrolled

12 Trials studying Stroke

35,753 Patients Enrolled for Stroke

NINDS Stroke Trials Network (StrokeNet)OTHER

1 Previous Clinical Trials

182 Total Patients Enrolled

1 Trials studying Stroke

182 Patients Enrolled for Stroke

Canadian Stroke Consortium (CSC)OTHER

3 Previous Clinical Trials

1,003 Total Patients Enrolled

2 Trials studying Stroke

958 Patients Enrolled for Stroke

Media Library

Statins (HMG-CoA reductase inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03936361 — Phase 3

Stroke Research Study Groups: No-statin, Statin

Stroke Clinical Trial 2023: Statins Highlights & Side Effects. Trial Name: NCT03936361 — Phase 3

Statins (HMG-CoA reductase inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03936361 — Phase 3

Stroke Patient Testimony for trial: Trial Name: NCT03936361 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What sort of risk does Statin present to patients?

"Our team at Power estimates that Statin is safe enough to be classified as a 3 on a scale from 1 to 3. This is because Statin is currently in Phase 3 of clinical trials, meaning that there is some data supporting its efficacy, as well as multiple rounds of data supporting its safety."

Answered by AI

Does this study have any available positions for participants?

"That is correct. As indicated on clinicaltrials.gov, this particular trial is still looking for patients. The posting date was June 10th, 2020 and the most recent update was February 28th, 2022. They are hoping to find 1,456 willing participants at a single location."

Answered by AI