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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02943590

Collaborator

Dana-Farber Cancer Institute (Other), Brigham and Women's Hospital (Other)

300

Enrollment

Locations

Arms

80.9

Anticipated Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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"

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

Study Type:

Interventional

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 :

Jan 13, 2017

Anticipated Primary Completion Date :

Aug 16, 2022

Anticipated Study Completion Date :

Oct 11, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Cardiac Events [2 years]
To determine whether statins reduce cardiac events (new onset heart failure)
Myocardial Fibrosis [6 months]
To determine The Effect Of Statins On Myocardial Fibrosis
Troponin T and Global Longitudinal Strain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts general Hospital	Boston	Massachusetts	United States	02114
2	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
3	University of Pennsylvania Medical System	Philadelphia	Pennsylvania	United States	19104
4	McGill University Health Center	Toronto		Canada

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tomas G. Neilan, MD, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT02943590

Other Study ID Numbers:

16-440

First Posted:

Oct 24, 2016

Last Update Posted:

Oct 15, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Tomas G. Neilan, MD, MD, Massachusetts General Hospital

Cancer Treatment Related to Heart Failure

Additional relevant MeSH terms:

Heart Failure

Cardiotoxicity

Atorvastatin

Study Results

No Results Posted as of Oct 15, 2021