Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07704918
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Immune checkpoint inhibitors (ICIs) are a class of medications that are now standard in the treatment of melanoma. These are standard therapy for melanoma, but long-term side effects on disease in the heart arteries is poorly understood. In this study, melanoma patients receiving ICIs for the first time will undergo a coronary computed tomography angiography (CCTA) scan. CCTA results will be analyzed by the FDA-approved Cleerly TM image analysis pipeline. Patients with disease in their heart arteries will be randomized to usual care or aggressive lipid lowering therapy. Those in the aggressive lipid lowering therapy arm will be seen by a cardiologist and placed on standard lipid lowering medications with a goal of achieving an LDL-C ≤ 55mg/dL. Follow-up CCTA scans will occur at 12-month and 24-month timepoints. The primary outcome of interest will be differences in LDL-C levels between the two arms at the 12-month timepoint. The secondary outcome of interest will be the differences in total plaque volume between the two arms at the 12-month timepoint.

Key Dates

First listed
Jul 15, 2026
Start date
Dec 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Active Comparator: Usual Care
    Active Comparator: Usual Care: 12- and 24-month follow-up CCTA with plaque staging, lipid panel
  • Experimental: Aggressive Lipid Lowering Therapy
    Participants in the 'aggressive lipid lowering therapy' arm will receive guideline-directed lipid lowering therapy (statins and/or PCSK9 inhibitors) managed by a cardiologist. Dosing adjustments will be guided by individual patient response and standard-of-care practices, with the goal of achieving LDL-C ≤55 mg/dL.

Primary Outcome Measure

Mean change in LDL-C from baseline to 12 months [ Time Frame: Baseline to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045
Zackry Morgan
[email protected]
720-848-5494
Caitlin Bell, MD (PRINCIPAL_INVESTIGATOR)
Sapna Patel, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Colorado Hospital· Aurora, CO

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