Clinical trial · Interventional
Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT)
NCT01988571CI-TRIAL-00055778completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research study is to see if Atorvastatin (Lipitor) 40 mg by mouth daily decreases the chance of developing heart problems in individuals receiving adjuvant anthracycline-based chemotherapy for breast cancer of lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1 - Atorvastatin
- description
- One 40 mg Atorvastatin tablet each morning by mouth for 24 months
- interventionNames
- Drug: Atorvastatin
- type
- PLACEBO_COMPARATOR
- label
- Arm 2 - Placebo
- description
- One placebo tablet each morning by mouth for 24 months.
- interventionNames
- Drug: Atorvastatin
- Drug: Placebo
Primary outcomes (1)
- measure
- Left Ventricular Ejection Fraction (LVEF)
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Stage I-III breast cancer (including inflammatory and newly diagnosed recurrent breast cancer) or lymphoma Stage I-IV. (Patients should have a \> 2 year life expectancy) * Scheduled to receive adjuvant chemotherapy with an Anthracycline (doxorubicin and epirubicin) * 21 years of age or older * LVEF \> 50% (Most recent within the last 5 years) * Prior administration of anthracyclines is acceptable if therapy was completed \> 6 months prior to study enrollment * Patients that are receiving or have received chemotherapy regimens are allowed * Able to hold breath for 10 seconds * Prior cancers allowed if no evidence of disease in last 5 years * Eastern Cooperative Oncology Group (ECOG) 0 or 1 Exclusion Criteria: * Prior use of lipid-lowering therapy within the last 6 months * Current postmenopausal hormone-replacement therapy * Uncontrolled hypertension (systolic blood pressure \>190 mm Hg or diastolic blood pressure \>100 mm Hg) * Scheduled to receive neoadjuvant chemotherapy with an anthracycline * No active liver disease allowed * Uncontrolled hypothyroidism * Recent history (within past 3 years) of alcohol or drug abuse, inflammatory conditions such as lupus or inflammatory bowel disease, use of immunosuppressant agents, or another medical condition that might compromise safety or the successful completion of the study. * Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal;pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices. * Unstable angina; significant ventricular arrhythmias (\>20 premature ventricular complexes (PVCs)/min due to gating difficulty) atrial fibrillation with uncontrolled ventricular response; coronary artery disease; acute myocardial infarction within 28 days * Current use of Cytochrome P450 (CYP3A4) inhibitors. These include Clarithromycin, HIV protease inhibitors, Itraconazole, grapefruit juice, Cyclosporine, Rifampin or Digoxin * Current or history of hepatic dysfunction * Unable to provide informed consent * Claustrophobia * Planning to move within 24 months of trial enrollment * Pregnant or breast-feeding
References
Publications (3)
- DERIVEDGrizzard PJ, O'Connell NS, Rapp SR, Olson KC, Bellissimo MP, Hughes AN, Ladd AC, Weaver KE, Wagner LI, Ruddy KJ, Ky B, D'Agostino RB, Hundley WG. Preserved Cognitive Function After Statin Administration During Cancer Treatment With Doxorubicin: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2538325. doi: 10.1001/jamanetworkopen.2025.38325. PMID 41118164
- DERIVEDSutton AL, O'Connell NS, Lucas AR, Olson KC, Reding KW, Sheppard VB, Ky B, Ruddy KJ, Weaver KE, Hundley WG. Socioeconomic status and left ventricular ejection fraction decline in breast cancer survivors following receipt of doxorubicin (PREVENT WF-98213). Cardiooncology. 2025 Feb 5;11(1):11. doi: 10.1186/s40959-025-00311-y. PMID 39910652
- DERIVEDHundley WG, D'Agostino R Jr, Crotts T, Craver K, Hackney MH, Jordan JH, Ky B, Wagner LI, Herrington DM, Yeboah J, Reding KW, Ladd AC, Rapp SR, Russo S, O'Connell N, Weaver KE, Dressler EV, Ge Y, Melin SA, Gudena V, Lesser GJ. Statins and Left Ventricular Ejection Fraction Following Doxorubicin Treatment. NEJM Evid. 2022 Sep;1(9):10.1056/evidoa2200097. doi: 10.1056/evidoa2200097. Epub 2022 Aug 18. PMID 36908314