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HMG-CoA Reductase Inhibitor

Statins for Myelodysplastic Syndrome

Phase 2

Recruiting

Led By Amber Afzal, M.D., MSCI

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-treatment, every 3 months while on treatment, end of treatment, 3 months after end of treatment and time of progression (estimated to be 15 months)

Awards & highlights

Study Summary

This trial is testing whether statins can help people with clonal cytopenia of undetermined significance or lower-risk myelodysplastic syndromes by delaying or preventing the expected increase in the variant allele frequency of somatic mutations over time.

Who is the study for?

This trial is for adults with CCUS or lower-risk MDS, which are conditions related to blood cell production. Participants must have specific genetic mutations and low levels of hemoglobin, white cells, or platelets. They should not be pregnant, breastfeeding, or have untreated HIV/HCV. Those who've taken statins in the last 6 months or other cancer treatments within a month can't join.Check my eligibility

What is being tested?

The study tests whether Atorvastatin and Rosuvastatin can reduce inflammation and slow down genetic changes in patients with CCUS/MDS. It aims to see if these common cholesterol-lowering drugs could extend life by preventing disease progression and cardiovascular events.See study design

What are the potential side effects?

Statins like Atorvastatin and Rosuvastatin may cause muscle pain, fatigue, digestive issues (like constipation), headaches, dizziness, increased blood sugar levels leading to diabetes risk, liver damage signs (e.g., yellowing skin/eyes), memory confusion or forgetfulness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-treatment, every 3 months while on treatment, end of treatment, 3 months after end of treatment and time of progression (estimated to be 15 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-treatment, every 3 months while on treatment, end of treatment, 3 months after end of treatment and time of progression (estimated to be 15 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment, every 3 months while on treatment, end of treatment, 3 months after end of treatment and time of progression (estimated to be 15 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

Change in hs-CTRP levels in peripheral blood during statin therapy

Secondary outcome measures

Change in allele burden (VAF) of somatic mutation

Side effects data

From 2014 Phase 3 trial • 58 Patients • NCT02084069

Postoperative bleeding

100%

80%

60%

40%

20%

Study treatment Arm

Treatment

Control

Trial Design

2Treatment groups

Experimental Treatment

Group I: RosuvastatinExperimental Treatment1 Intervention

Choice of statin is at the discretion of the treating physician and may depend on insurance approval. Rosuvastatin dosing starts at 40 mg once daily. In the absence of disease progression or intolerable side effects, patients may receive up to 12 months of treatment. If a patient switches statins due to toxicity, treatment time is still limited to 12 months total (ie, if a patient receives 6 months of atorvastatin and switches to rosuvastatin, the duration of rosuvastatin will be no more than 6 months).

Group II: AtorvastatinExperimental Treatment1 Intervention

Choice of statin is at the discretion of the treating physician and may depend on insurance approval. Atorvastatin dosing starts at 80 mg once daily. In the absence of disease progression or intolerable side effects, patients may receive up to 12 months of treatment. If a patient switches statins due to toxicity, treatment time is still limited to 12 months total (ie, if a patient receives 6 months of atorvastatin and switches to rosuvastatin, the duration of rosuvastatin will be no more than 6 months).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rosuvastatin

2019

Completed Phase 4

~3150

Atorvastatin

1998

Completed Phase 4

~10900

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,791 Total Patients Enrolled

Amber Afzal, M.D., MSCIPrincipal InvestigatorWashington University School of Medicine

Media Library

Atorvastatin (HMG-CoA Reductase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05483010 — Phase 2

Myelodysplastic Syndrome Research Study Groups: Rosuvastatin, Atorvastatin

Myelodysplastic Syndrome Clinical Trial 2023: Atorvastatin Highlights & Side Effects. Trial Name: NCT05483010 — Phase 2

Atorvastatin (HMG-CoA Reductase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05483010 — Phase 2

Frequently Asked Questions

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

Are there vacancies in this research for new participants?

"Unfortunately, this particular trial is not recruiting patients at the current moment. This was last updated on July 28th, 2022 and the study was first posted on October 31st, 2020. Although this may not be an option for those looking to participate in a clinical trial, there are 1,980 other studies that are currently open for recruitment."

Answered by AI