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

16-440

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"

2017-01-13

2022-09-16

2023-10-11

Completed

Early phase I

300

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ACTUAL'}}

2023-12-18