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

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ClinicalTrials.gov Identifier: NCT02943590
Recruitment Status : Completed
First Posted : October 24, 2016
Results First Posted : December 18, 2023
Last Update Posted : December 18, 2023
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by (Responsible Party):
Tomas G. Neilan, MD, Massachusetts General Hospital

Study Description
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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"

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Placebo Drug: Atorvastatin Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)
Actual Study Start Date : January 13, 2017
Actual Primary Completion Date : September 16, 2022
Actual Study Completion Date : October 11, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo will be administered at a pre determined dose The drug is taken by mouth, once a day (evening)
 Drug: Placebo
A pill taken once a day
Experimental: Atorvastatin
Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening)
 Drug: Atorvastatin
A pill taken once a day
Other Name: Lipitor


Outcome Measures
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Primary Outcome Measures :
  1. The Percentage of Individuals in Each Group With a Significant Decline in the LVEF. [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. The Percentage of Participants in Each Group With New Onset Heart Failure. [ Time Frame: 2 years ]
    To determine whether statins reduce the percentage of participants in each group with new onset heart failure after anthracyclines.

  2. Myocardial Extracellular Volume by Cardiac MRI. [ Time Frame: 1 Year ]
    To determine if anthracyclines lead to an increase in myocardial fibrosis, myocardial extracellular volume, as measured by cardiac MRI and whether statins attenuate the increase in myocardial fibrosis.

  3. Global Longitudinal Strain [ Time Frame: 1 Year ]
    To determine whether anthracyclines lead to a reduction in global longitudinal strain (GLS), whether the reduction in GLS associates with the decline in LVEF and whether statins attenuate the anthracycline-associated reduction in GLS.

  4. Troponin [ Time Frame: 1 year ]
    To determine if anthracyclines lead to an increase in serum troponin, to determine if the increase in serum troponin related to the decline in cardiac function and whether statins attenuate the increase in serum troponin.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943590


Locations
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United States, Massachusetts
Massachusetts general Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
University of Pennsylvania Medical System
Philadelphia, Pennsylvania, United States, 19104
Canada
McGill University Health Center
Toronto, Canada
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
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Principal Investigator: Tomas G Neilan, MD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Tomas G. Neilan, MD, Massachusetts General Hospital:
Study Protocol  [PDF] February 2, 2017
Statistical Analysis Plan  [PDF] June 7, 2022
Informed Consent Form  [PDF] April 1, 2022

More Information
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Responsible Party: Tomas G. Neilan, MD, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02943590    
Other Study ID Numbers: 16-440
First Posted: October 24, 2016    Key Record Dates
Results First Posted: December 18, 2023
Last Update Posted: December 18, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tomas G. Neilan, MD, Massachusetts General Hospital:
Cancer Treatment Related to Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Cardiotoxicity
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
 Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors