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

November 29, 2023 updated by: Tomas G. Neilan, MD, Massachusetts General Hospital
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"

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Toronto, Canada
        • McGill University Health Center
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Medical System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
1 Year
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.
1 Year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Dana-Farber Cancer Institute
Brigham and Women's Hospital

Investigators

  • Principal Investigator: Tomas G Neilan, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2017

Primary Completion (Actual)

September 16, 2022

Study Completion (Actual)

October 11, 2023

Study Registration Dates

First Submitted

October 21, 2016

First Submitted That Met QC Criteria

October 21, 2016

First Posted (Estimated)

October 24, 2016

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-440

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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