Phase 2
N=300
STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02943590 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: The Percentage of Individuals in Each Group With a Significant Decline in the LVEF. — 22; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Atorvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Individuals in Each Group With a Significant Decline in the LVEF. |
22; 9 | — |
| SECONDARY The Percentage of Participants in Each Group With New Onset Heart Failure. |
6; 3 | — |
| SECONDARY Myocardial Extracellular Volume by Cardiac MRI. |
29; 8 | — |
| SECONDARY Global Longitudinal Strain (GLS) |
28; 19 | — |
Summary
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"
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02943590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.