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

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ClinicalTrials.gov Identifier: NCT02943590
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by (Responsible Party):
Tomas Neilan, MD, Massachusetts General Hospital

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 Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : May 2022


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




Primary Outcome Measures :
  1. Left ventricular Ejection Fraction (LVEF) [ Time Frame: 12 months ]
    To determine if statins preserve the LVEF at 12 months


Secondary Outcome Measures :
  1. Number of Cardiac Events [ Time Frame: 2 years ]
    To determine whether statins reduce cardiac events (new onset heart failure)

  2. Myocardial Fibrosis [ Time Frame: 6 months ]
    To determine The Effect Of Statins On Myocardial Fibrosis

  3. Troponin T and Global Longitudinal Strain [ Time Frame: 3 months ]
    To determine whether changes in troponin T or global longitudinal strain by echocardiography at 3 months predict the reduction in LVEF at 12 months on MRI.



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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
  • Scheduled to receive anthracycline-based therapy of the CHOP/RCHOP type

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

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


Contacts
Contact: Tomas G Neilan, MD 617-643-0239

Locations
United States, Massachusetts
Massachusetts general Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Tomas Neilan, MD    617-643-0239      
Principal Investigator: Tomas Neilan, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Eric Jacobsen, MD    617-632-4564      
Principal Investigator: Eric Jacobsen, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
Principal Investigator: Tomas G Neilan, MD Massachusetts General Hospital

Responsible Party: Tomas Neilan, MD, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02943590     History of Changes
Other Study ID Numbers: 16-440
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tomas Neilan, MD, Massachusetts General Hospital:
Cancer Treatment Related to Heart Failure

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Heart Failure
Cardiotoxicity
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors