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

Primary Purpose

Heart Failure

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Atorvastatin
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cancer Treatment Related to Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts general Hospital
  • Dana Farber Cancer Institute
  • University of Pennsylvania Medical System
  • McGill University Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Atorvastatin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Left ventricular Ejection Fraction (LVEF)
To determine if statins preserve the LVEF at 12 months

Secondary Outcome Measures

Number of Cardiac Events
To determine whether statins reduce cardiac events (new onset heart failure)
Myocardial Fibrosis
To determine The Effect Of Statins On Myocardial Fibrosis
Troponin T and Global Longitudinal Strain
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.

Full Information

First Posted
October 21, 2016
Last Updated
November 14, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02943590
Brief Title
STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)
Official Title
STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 13, 2017 (Actual)
Primary Completion Date
September 16, 2022 (Actual)
Study Completion Date
October 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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"
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cancer Treatment Related to Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered at a pre determined dose The drug is taken by mouth, once a day (evening)
Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A pill taken once a day
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
A pill taken once a day
Primary Outcome Measure Information:
Title
Left ventricular Ejection Fraction (LVEF)
Description
To determine if statins preserve the LVEF at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Cardiac Events
Description
To determine whether statins reduce cardiac events (new onset heart failure)
Time Frame
2 years
Title
Myocardial Fibrosis
Description
To determine The Effect Of Statins On Myocardial Fibrosis
Time Frame
6 months
Title
Troponin T and Global Longitudinal Strain
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas G Neilan, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts general Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Pennsylvania Medical System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
McGill University Health Center
City
Toronto
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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