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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-13

Study Completion Date

2023-10-11

Brief Summary

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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"

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

A pill taken once a day

Atorvastatin

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

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

A pill taken once a day

Interventions

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Placebo

A pill taken once a day

Intervention Type DRUG

Atorvastatin

A pill taken once a day

Intervention Type DRUG

Other Intervention Names

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Lipitor

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No