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Heart FailurePhase 2NCT02943590

STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)

A Phase 2 study testing Atorvastatin in people with Heart Failure, run by Massachusetts General Hospital at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research study will test whether atorvastatin, a drug commonly prescribed for reducing cholesterol levels, can protect the heart during chemotherapy with doxorubicin. Atorvastatin is from a family of medications that are commonly called "statins" Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Atorvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
4 sitesin 2 countries
Study dates
13 Jan 2017to 11 Oct 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • > 18 years of age
  • All patients with newly diagnosed NHL and HL
  • Scheduled to receive anthracycline-based therapy

Who cannot join

  • Statin use or Statin use is indicated based on guidelines
  • Pregnancy or breastfeeding
  • Unable to provide informed consent
  • Unexplained persistent elevation of transaminases (>3 times upper limits of normal)
  • Concomitant use of cyclosporine
  • Renal failure: estimated glomerular filtration <45 mL/min/1.73 m2
  • Contraindication to a CMR (metallic object, severe claustrophobia, pacemaker, vascular clip
  • LVEF of <50% at baseline

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States3 sites

  • Massachusetts general Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • University of Pennsylvania Medical System

    Philadelphia, Pennsylvania, 19104

Other trials in United States

Canada1 site

  • McGill University Health Center

    Toronto

Other trials in Canada

About this study

This research study will test whether atorvastatin, a drug commonly prescribed for reducing cholesterol levels, can protect the heart during chemotherapy with doxorubicin. Atorvastatin is from a family of medications that are commonly called "statins"

Read the detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of a drug and determine whether the investigational drug works in treating a specific disease. "Investigational" means that the drug is being studied.

The chemotherapy drug that the participant have been scheduled to be treated with, Doxorubicin, has been associated with the development of heart failure in some patients.

This research study is testing whether Atorvastatin can protect the hearts of patients being treated with Doxorubicin and can reduce cardiac injury and the risk of heart failure. Atorvastatin is not approved by the FDA (the U.S. Food and Drug Administration) for use to reduce the cardiac injury after Doxorubicin. Atorvastatin is approved by the FDA for lowering cholesterol and for reducing the risk of heart attack and stroke. The heart is a muscle that pumps blood and Atorvastatin may protect the heart by preserving cardiac muscle function.

The investigators will test whether atorvastatin protects the heart using a combination of imaging tests on the participants heart, blood tests, and stress testing. The imaging tests will involve an echocardiogram (an echo) and cardiac magnetic resonance (CMR), a type of magnetic resonance imaging (MRI) scan.

Conditions
Heart Failure
Being tested
Placebo, Atorvastatin
Keywords
Cancer Treatment Related to Heart Failure
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    A pill taken once a day

  • AtorvastatinDrug

    Also called Lipitor

    A pill taken once a day

Study groups in NCT02943590
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo will be administered at a pre determined dose The drug is taken by mouth, once a day (evening)
Receives: Drug: Placebo
AtorvastatinExperimentalAtorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening)
Receives: Drug: Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Percentage of Individuals in Each Group With a Significant Decline in the LVEF.

    To determine if the administration of statins is associated with a lower percentage of individuals who experience a significant decline in the LVEF at 12 months. The primary outcome was the percentage of participants with an absolute decline in left ventricular ejection fraction (LVEF) of>10% from prior to chemotherapy to a final value of <55% over 12 months.

    Measured: 12 months

Secondary outcomes (3)

  1. The Percentage of Participants in Each Group With New Onset Heart Failure.

    To determine whether statins reduce the percentage of participants in each group with new onset heart failure after anthracyclines.

    Measured: 2 years

  2. Myocardial Extracellular Volume by Cardiac MRI.

    The myocardial extracellular volume (ECV) is the proportion of the myocardium that is estimated to be of extracellular space. Myocardium consists of intracellular space and extracellular space. This measure is an imaging estimate of the extracellular space. The extracellular space can be expanded in diseases where myocardial fibrosis is increased. Thus, this measure is often used as an estimate for the proportion of fibrosis in the heart. It can be expressed as a percentage. Here, based on published literature, we used a cut off of a 3% increase in the ECV from baseline to follow-up as a meaningful increase and compared the propositions of persons with that 3% increase in each group. We are comparing the proportion of persons in each group with a 3% or greater increase in the ECV.

    Measured: 1 Year

  3. Global Longitudinal Strain (GLS)

    GLS is a sensitive measure of cardiac systolic function. Anthracyclines can be associated with impaired global longitudinal strain (GLS). Whether atorvastatin protects against a decline in LV GLS is unknown. GLS is expressed as a percentage. A ≥15% relative decrease in LV GLS was used as a cut off for a significant decrease in GLS based on published data. The Proportions of participants with a relative reduction of ≥15% in LV GLS were evaluated in each group.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2016 (estimated)
  2. Study start13 Jan 2017
  3. Primary completion16 Sep 2022
  4. Study completion11 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02943590
Sponsor's protocol ID
16-440
Status last verified
May 2025
First submitted
21 Oct 2016
Last updated
15 May 2025
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Juhasz V, Quinaglia T, Drobni ZD, Gilman HK, Heemelaar JC, Neuberg DS, Han Y, Ky B, Kwong RY, Januzzi JL, Asnani A, Redd RA, Mousavi N, Jerosch-Herold M, Scherrer-Crosbie M, Neilan TG. Atorvastatin and left ventricular strain during anthracycline-based chemotherapy. Int J Cardiol. 2026 Jul 1;454:134439. doi: 10.1016/j.ijcard.2026.134439. Epub 2026 Mar 22.

    PubMed 41875954

  • Juhasz V, Drobni ZD, Quinaglia T, Gilman HK, Brendel JM, Suero-Abreu GA, Ghamari A, Heemelaar JC, Neuberg DS, Han Y, Ky B, Kwong RY, Januzzi JL, Asnani A, Mousavi N, Redd RA, Jerosch-Herold M, Scherrer-Crosbie M, Neilan TG. Atorvastatin and Aortic Stiffness During Anthracycline-Based Chemotherapy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2026 Jan 1;11(1):68-76. doi: 10.1001/jamacardio.2025.4548.

    PubMed 41205202

  • Juhasz V, Drobni ZD, Quinaglia T, Gilman HK, Suero-Abreu GA, Ghamari A, Heemelaar JC, Neuberg DS, Han Y, Ky B, Kwong RY, Januzzi JL, Asnani A, Mousavi N, Redd RA, Jerosch-Herold M, Scherrer-Crosbie M, Neilan TG. Atorvastatin and left atrial function during anthracycline-based chemotherapy. J Cardiovasc Magn Reson. 2025 Winter;27(2):101946. doi: 10.1016/j.jocmr.2025.101946. Epub 2025 Aug 26.

    PubMed 40876541

  • Juhasz V, Quinaglia T, Drobni ZD, Heemelaar JC, Neuberg DS, Han Y, Ky B, Kwong RY, Januzzi JL, Asnani A, Redd RA, Mousavi N, Jerosch-Herold M, Scherrer-Crosbie M, Neilan TG. Atorvastatin and Myocardial Extracellular Volume Expansion During Anthracycline-Based Chemotherapy. JACC CardioOncol. 2025 Feb;7(2):125-137. doi: 10.1016/j.jaccao.2024.11.008. Epub 2025 Jan 28.

    PubMed 39967198

  • Nemec R, Scherrer-Crosbie M, Abramson JS, Redd R, Gilman HK, Ho T, Wu J, Heemelaar J, Neuberg D, Hochberg EP, Barnes JA, Armand P, Jacobsen ED, Jacobson CA, Kim AI, Friedman RS, LaCasce AS, Neilan TG, Soumerai JD. Effect of atorvastatin versus placebo on efficacy in patients with diffuse large B-cell lymphoma receiving R-CHOP. Leuk Lymphoma. 2024 Jun;65(6):783-788. doi: 10.1080/10428194.2024.2317343. Epub 2024 Feb 21.

    PubMed 38380861

  • Neilan TG, Quinaglia T, Onoue T, Mahmood SS, Drobni ZD, Gilman HK, Smith A, Heemelaar JC, Brahmbhatt P, Ho JS, Sama S, Svoboda J, Neuberg DS, Abramson JS, Hochberg EP, Barnes JA, Armand P, Jacobsen ED, Jacobson CA, Kim AI, Soumerai JD, Han Y, Friedman RS, Lacasce AS, Ky B, Landsburg D, Nasta S, Kwong RY, Jerosch-Herold M, Redd RA, Hua L, Januzzi JL, Asnani A, Mousavi N, Scherrer-Crosbie M. Atorvastatin for Anthracycline-Associated Cardiac Dysfunction: The STOP-CA Randomized Clinical Trial. JAMA. 2023 Aug 8;330(6):528-536. doi: 10.1001/jama.2023.11887.

    PubMed 37552303

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atorvastatin in people with Heart Failure, run by Massachusetts General Hospital at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Percentage of Individuals in Each Group With a Significant Decline in the LVEF. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02943590, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.

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Clinical Trial NCT02943590 | AzTrials