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

NCT02943590 | Completed Phase 2 Results DMC

• 1 other identifier: 16-440
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 4

Brief 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"

Conditions

Heart Failure

Keywords

Cancer Treatment Related to Heart Failure

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (3)

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

  2 years

• Myocardial Extracellular Volume by Cardiac MRI.

  1 Year

• Global Longitudinal Strain (GLS)

  1 year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo will be administered at a pre determined dose The drug is taken by mouth, once a day (evening)

Drug: Placebo

Atorvastatin

EXPERIMENTAL

Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening)

Drug: Atorvastatin

Interventions

Placebo DRUG

A pill taken once a day

Placebo

Atorvastatin DRUG

A pill taken once a day

Also known as: Lipitor

Atorvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (4)

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Pennsylvania Medical System

Philadelphia, Pennsylvania, 19104, United States

Location

McGill University Health Center

Toronto, Canada

Location

Related Publications (4)

• 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. 2025 Nov 8:e254548. doi: 10.1001/jamacardio.2025.4548. Online ahead of print.

  PMID: 41205202 DERIVED

• 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.

  PMID: 40876541 DERIVED

• 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.

  PMID: 39967198 DERIVED

• 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.

  PMID: 37552303 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Tomas Neilan
• Organization: MassGH

tneilan@partners.org

617726200

Study Officials

• Tomas G Neilan, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 24, 2016
• Study Start: January 13, 2017
• Primary Completion: September 16, 2022
• Study Completion: October 11, 2023
• Last Updated: May 15, 2025
• Results First Posted: December 18, 2023

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); CA (1)