Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Brigham and Women's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) |
|
| Atorvastatin | Experimental | Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | A pill taken once a day |
| |
| Atorvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Individuals in Each Group With a Significant Decline in the LVEF. | To determine if the administration of statins is associated with a lower percentage of individuals who experience a significant decline in the LVEF at 12 months. The primary outcome was the percentage of participants with an absolute decline in left ventricular ejection fraction (LVEF) of>10% from prior to chemotherapy to a final value of <55% over 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants in Each Group With New Onset Heart Failure. | To determine whether statins reduce the percentage of participants in each group with new onset heart failure after anthracyclines. | 2 years |
| Myocardial Extracellular Volume by Cardiac MRI. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tomas G Neilan, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts general Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41875954 | Derived | Juhasz V, Quinaglia T, Drobni ZD, Gilman HK, Heemelaar JC, Neuberg DS, Han Y, Ky B, Kwong RY, Januzzi JL, Asnani A, Redd RA, Mousavi N, Jerosch-Herold M, Scherrer-Crosbie M, Neilan TG. Atorvastatin and left ventricular strain during anthracycline-based chemotherapy. Int J Cardiol. 2026 Jul 1;454:134439. doi: 10.1016/j.ijcard.2026.134439. Epub 2026 Mar 22. | |
| 41205202 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
1:1 randomization
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Placebo: A pill taken once a day |
| FG001 | Atorvastatin | Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Atorvastatin: A pill taken once a day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo group |
| BG001 | Atorvastatin | Atorvastatin group |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Individuals in Each Group With a Significant Decline in the LVEF. | To determine if the administration of statins is associated with a lower percentage of individuals who experience a significant decline in the LVEF at 12 months. The primary outcome was the percentage of participants with an absolute decline in left ventricular ejection fraction (LVEF) of>10% from prior to chemotherapy to a final value of <55% over 12 months. | Posted | Count of Participants | Participants | 12 months |
|
12 months
No difference
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Placebo: A pill taken once a day |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tomas Neilan | MassGH | 617726200 | tneilan@partners.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2017 | Oct 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2022 | Oct 18, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2022 | Nov 29, 2023 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
A pill taken once a day |
|
|
The myocardial extracellular volume (ECV) is the proportion of the myocardium that is estimated to be of extracellular space. Myocardium consists of intracellular space and extracellular space. This measure is an imaging estimate of the extracellular space. The extracellular space can be expanded in diseases where myocardial fibrosis is increased. Thus, this measure is often used as an estimate for the proportion of fibrosis in the heart. It can be expressed as a percentage. Here, based on published literature, we used a cut off of a 3% increase in the ECV from baseline to follow-up as a meaningful increase and compared the propositions of persons with that 3% increase in each group. We are comparing the proportion of persons in each group with a 3% or greater increase in the ECV. |
| 1 Year |
| Global Longitudinal Strain (GLS) | GLS is a sensitive measure of cardiac systolic function. Anthracyclines can be associated with impaired global longitudinal strain (GLS). Whether atorvastatin protects against a decline in LV GLS is unknown. GLS is expressed as a percentage. A ≥15% relative decrease in LV GLS was used as a cut off for a significant decrease in GLS based on published data. The Proportions of participants with a relative reduction of ≥15% in LV GLS were evaluated in each group. | 1 year |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| University of Pennsylvania Medical System | Philadelphia | Pennsylvania | 19104 | United States |
| McGill University Health Center | Toronto | Canada |
| Juhasz V, Drobni ZD, Quinaglia T, Gilman HK, Brendel JM, Suero-Abreu GA, Ghamari A, Heemelaar JC, Neuberg DS, Han Y, Ky B, Kwong RY, Januzzi JL, Asnani A, Mousavi N, Redd RA, Jerosch-Herold M, Scherrer-Crosbie M, Neilan TG. Atorvastatin and Aortic Stiffness During Anthracycline-Based Chemotherapy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2026 Jan 1;11(1):68-76. doi: 10.1001/jamacardio.2025.4548. |
| 40876541 | Derived | Juhasz V, Drobni ZD, Quinaglia T, Gilman HK, Suero-Abreu GA, Ghamari A, Heemelaar JC, Neuberg DS, Han Y, Ky B, Kwong RY, Januzzi JL, Asnani A, Mousavi N, Redd RA, Jerosch-Herold M, Scherrer-Crosbie M, Neilan TG. Atorvastatin and left atrial function during anthracycline-based chemotherapy. J Cardiovasc Magn Reson. 2025 Winter;27(2):101946. doi: 10.1016/j.jocmr.2025.101946. Epub 2025 Aug 26. |
| 39967198 | Derived | Juhasz V, Quinaglia T, Drobni ZD, Heemelaar JC, Neuberg DS, Han Y, Ky B, Kwong RY, Januzzi JL, Asnani A, Redd RA, Mousavi N, Jerosch-Herold M, Scherrer-Crosbie M, Neilan TG. Atorvastatin and Myocardial Extracellular Volume Expansion During Anthracycline-Based Chemotherapy. JACC CardioOncol. 2025 Feb;7(2):125-137. doi: 10.1016/j.jaccao.2024.11.008. Epub 2025 Jan 28. |
| 38380861 | Derived | Nemec R, Scherrer-Crosbie M, Abramson JS, Redd R, Gilman HK, Ho T, Wu J, Heemelaar J, Neuberg D, Hochberg EP, Barnes JA, Armand P, Jacobsen ED, Jacobson CA, Kim AI, Friedman RS, LaCasce AS, Neilan TG, Soumerai JD. Effect of atorvastatin versus placebo on efficacy in patients with diffuse large B-cell lymphoma receiving R-CHOP. Leuk Lymphoma. 2024 Jun;65(6):783-788. doi: 10.1080/10428194.2024.2317343. Epub 2024 Feb 21. |
| 37552303 | Derived | Neilan TG, Quinaglia T, Onoue T, Mahmood SS, Drobni ZD, Gilman HK, Smith A, Heemelaar JC, Brahmbhatt P, Ho JS, Sama S, Svoboda J, Neuberg DS, Abramson JS, Hochberg EP, Barnes JA, Armand P, Jacobsen ED, Jacobson CA, Kim AI, Soumerai JD, Han Y, Friedman RS, Lacasce AS, Ky B, Landsburg D, Nasta S, Kwong RY, Jerosch-Herold M, Redd RA, Hua L, Januzzi JL, Asnani A, Mousavi N, Scherrer-Crosbie M. Atorvastatin for Anthracycline-Associated Cardiac Dysfunction: The STOP-CA Randomized Clinical Trial. JAMA. 2023 Aug 8;330(6):528-536. doi: 10.1001/jama.2023.11887. |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| LVEF | Mean | Standard Deviation | % |
|
Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening)
Atorvastatin: A pill taken once a day
|
|
| Secondary | The Percentage of Participants in Each Group With New Onset Heart Failure. | To determine whether statins reduce the percentage of participants in each group with new onset heart failure after anthracyclines. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Myocardial Extracellular Volume by Cardiac MRI. | The myocardial extracellular volume (ECV) is the proportion of the myocardium that is estimated to be of extracellular space. Myocardium consists of intracellular space and extracellular space. This measure is an imaging estimate of the extracellular space. The extracellular space can be expanded in diseases where myocardial fibrosis is increased. Thus, this measure is often used as an estimate for the proportion of fibrosis in the heart. It can be expressed as a percentage. Here, based on published literature, we used a cut off of a 3% increase in the ECV from baseline to follow-up as a meaningful increase and compared the propositions of persons with that 3% increase in each group. We are comparing the proportion of persons in each group with a 3% or greater increase in the ECV. | Persons with available and high quality MRI data where the variable could be measured. | Posted | Count of Participants | Participants | 1 Year |
|
|
|
| Secondary | Global Longitudinal Strain (GLS) | GLS is a sensitive measure of cardiac systolic function. Anthracyclines can be associated with impaired global longitudinal strain (GLS). Whether atorvastatin protects against a decline in LV GLS is unknown. GLS is expressed as a percentage. A ≥15% relative decrease in LV GLS was used as a cut off for a significant decrease in GLS based on published data. The Proportions of participants with a relative reduction of ≥15% in LV GLS were evaluated in each group. | The number of persons in each group with high quality imaging data where the variable could be analyzed. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 4 |
| 150 |
| 0 |
| 150 |
| 21 |
| 150 |
| EG001 | Atorvastatin | Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Atorvastatin: A pill taken once a day | 4 | 150 | 0 | 150 | 28 | 150 |
Not provided
Not provided
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |