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

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Heart Failure

Treatments: Drug: Placebo; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02943590

16-440

Details and patient eligibility

About

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"

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Atorvastatin

Experimental group

Description:

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

Treatment:

Drug: Atorvastatin