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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:January 13, 2017
End Date:May 2022
Contact:Tomas G Neilan, MD
Phone:617-643-0239

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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"

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.

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
We found this trial at
2
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Eric Jacobsen, MD
Phone: 617-632-4564
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Tomas Neilan, MD
Phone: 617-643-0239
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