STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)
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|ClinicalTrials.gov Identifier: NCT02943590|
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: Placebo Drug: Atorvastatin||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)|
|Actual Study Start Date :||January 13, 2017|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||May 2022|
Placebo Comparator: Placebo
Placebo will be administered at a pre determined dose The drug is taken by mouth, once a day (evening)
A pill taken once a day
Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening)
A pill taken once a day
Other Name: Lipitor
- Left ventricular Ejection Fraction (LVEF) [ Time Frame: 12 months ]To determine if statins preserve the LVEF at 12 months
- Number of Cardiac Events [ Time Frame: 2 years ]To determine whether statins reduce cardiac events (new onset heart failure)
- Myocardial Fibrosis [ Time Frame: 6 months ]To determine The Effect Of Statins On Myocardial Fibrosis
- Troponin T and Global Longitudinal Strain [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943590
|Contact: Tomas G Neilan, MD||617-643-0239|
|United States, Massachusetts|
|Massachusetts general Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Tomas Neilan, MD 617-643-0239|
|Principal Investigator: Tomas Neilan, MD|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Eric Jacobsen, MD 617-632-4564|
|Principal Investigator: Eric Jacobsen, MD|
|Principal Investigator:||Tomas G Neilan, MD||Massachusetts General Hospital|