[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07704918":3,"trial-entities:NCT07704918":115,"trial-summary:NCT07704918":121},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":57,"minimum_age":58,"maximum_age":17,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":85,"locations":88,"central_contacts":109,"overall_officials":111,"references":113,"see_also_links":114},"NCT07704918","25-1921.cc","Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma","Lipid Lowering Therapy for Atherosclerotic Disease in Melanoma Patients Receiving Immune Checkpoint Inhibitors","NOT_YET_RECRUITING","2028-12","2026-07","2026-07-15","2026-12-31","University of Colorado, Denver","OTHER",true,"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\u002FdL. 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.",null,[19],"Melanoma",[21,22,23],"atherosclerosis","coronary artery disease","coronary atherosclerosis","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},40,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Statins (atorvastatin, rosuvastatin, simvastatin, or pravastatin), +\u002F- ezetimibe, +\u002F- PCSK9 inhibitor (alirocumab, evolocumab, inclisiran)","Participants randomized to the aggressive lipid lowering therapy arm will receive Guideline-directed lipid-lowering therapy (statins and\u002For ezetimibe and\u002For PCSK9 inhibitors) managed by a cardiologist with dose adjustments to achieve LDL-C ≤55 mg\u002FdL.",[37],"Aggressive Lipid Lowering Therapy",[39],{"measure":40,"description":41,"timeFrame":42},"Mean change in LDL-C from baseline to 12 months","Each participant will have LDL-C measured prior to randomization and at the 12-month timepoint. The mean change in LDL-C (mg\u002FdL) from baseline to 12 months will be calculated for each participant. The mean change will be compared between the aggressive lipid-lowering therapy arm and the usual care arm.","Baseline to 12 months",[44,48,51,54],{"measure":45,"description":46,"timeFrame":47},"Change in Total Plaque Volume from Baseline to 12 months","Each participant will have total plaque volume measured prior to randomization and at the 12-month timepoint via Cleerly TM's CCTA image analysis pipeline. The mean change in total coronary plaque volume (mm³), as measured by coronary computed tomography angiography (CCTA) using the Cleerly™ image analysis pipeline, from baseline to 12 months will be calculated for each participant and compared between study arms.","12 months",{"measure":49,"description":50,"timeFrame":47},"Major adverse cardiovascular events at 12 months","Major adverse cardiovascular events between 0 and 12 months will be noted to determine if there is a difference in major adverse cardiovascular events (MACE) rates between the usual care arm versus the aggressive lipid lowering arm.",{"measure":52,"description":53,"timeFrame":47},"Change in Calcified Plaque Volume from Baseline to 12 Months","Each participant will have proportion of calcified plaque volume measured prior to randomization and at the 12-month timepoint via Cleerly TM's CCTA image analysis pipeline. The difference between these two timepoints in each participant will be calculated to determine if there is a significant difference between proportion of calcified plaque volume changes in the usual care arm versus the aggressive lipid lowering arm.",{"measure":55,"description":56,"timeFrame":47},"Change in Size of the Largest Plaque from Baseline to 12 Months","Each participant will have the size of the largest plaque (by volume) measured prior to randomization and at the 12-month timepoint via Cleerly TM's CCTA image analysis pipeline. The difference between these two timepoints in each participant will be calculated to determine if there is a significant difference between largest plaque volume changes in the usual care arm versus the aggressive lipid lowering arm.","ALL","55 Years",false,{"inclusion":61,"exclusion":68,"raw_text":84},[62,63,64,65,66,67],"Provision to sign and date the consent form.","Stated willingness to comply with all study procedures and be available for the duration of the study.","Be a male aged ≥55 years or a female aged ≥65 years.","For those able to bear children, documentation of menopausal status via approximate last menstrual period or hysterectomy due to contraindication of pregnancy for the CCTA procedure.","Have a melanoma diagnosis without prior ICI use and planning to start on ICI therapy (PD-1, PD-L1, CTLA-4, LAG3) as standard of care for their cancer.","Plaque stage ≥ 1 on screening CCTA.",[69,70,71,72,73,74,75,76,77,78,79,80,81,82,83],"Any prior major cardiovascular event, defined as myocardial infarction, stroke, coronary revascularization, or other major cardiovascular event determined to be significant by the principal investigator.","Meeting any of the standard CCTA contraindications listed below:","Allergy to iodinated contrast or history of contrast-induced nephropathy","Renal insufficiency (eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) or Modification of Diet in Renal Disease (MDRD) equation). A current eGFR value (collected\u002Fcalculated within 3 months from screening visit) is required at baseline.","Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., \\> 80 beats per minute). EKG must be performed within 1 year of screening visit.","Hemodynamic instability","Weight \\> 400 lbs. (181 kg) or above manufacturer-recommended limit for scanner and table, whichever is lower","Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment","Pregnancy","Inability to hold breath for \\> 10 seconds","Contraindication to dosing with beta blocker as needed or nitroglycerin prior to CCTA procedure","Inability to cooperate with scan acquisition and\u002For breath-hold instructions","Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA","If a patient's fast LDL-C is \\> 190 mg\u002FdL, this is consistent with underlying familial hypercholesterolemia, and they will not be eligible for the study.","If a patient's CCTA demonstrates previously undiagnosed obstructive coronary disease, they will not be eligible for the study. Obstructive disease will be defined as \\>50% obstruction in the left main coronary artery, or \\>70% obstruction elsewhere in the coronary tree.","Inclusion Criteria:\n\n* Provision to sign and date the consent form.\n* Stated willingness to comply with all study procedures and be available for the duration of the study.\n* Be a male aged ≥55 years or a female aged ≥65 years.\n* For those able to bear children, documentation of menopausal status via approximate last menstrual period or hysterectomy due to contraindication of pregnancy for the CCTA procedure.\n* Have a melanoma diagnosis without prior ICI use and planning to start on ICI therapy (PD-1, PD-L1, CTLA-4, LAG3) as standard of care for their cancer.\n* Plaque stage ≥ 1 on screening CCTA.\n\nExclusion Criteria:\n\n* Any prior major cardiovascular event, defined as myocardial infarction, stroke, coronary revascularization, or other major cardiovascular event determined to be significant by the principal investigator.\n* Meeting any of the standard CCTA contraindications listed below:\n* Allergy to iodinated contrast or history of contrast-induced nephropathy\n* Renal insufficiency (eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) or Modification of Diet in Renal Disease (MDRD) equation). A current eGFR value (collected\u002Fcalculated within 3 months from screening visit) is required at baseline.\n* Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., \\> 80 beats per minute). EKG must be performed within 1 year of screening visit.\n* Hemodynamic instability\n* Weight \\> 400 lbs. (181 kg) or above manufacturer-recommended limit for scanner and table, whichever is lower\n* Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment\n* Pregnancy\n* Inability to hold breath for \\> 10 seconds\n* Contraindication to dosing with beta blocker as needed or nitroglycerin prior to CCTA procedure\n* Inability to cooperate with scan acquisition and\u002For breath-hold instructions\n* Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA\n* If a patient's fast LDL-C is \\> 190 mg\u002FdL, this is consistent with underlying familial hypercholesterolemia, and they will not be eligible for the study.\n* If a patient's CCTA demonstrates previously undiagnosed obstructive coronary disease, they will not be eligible for the study. Obstructive disease will be defined as \\>50% obstruction in the left main coronary artery, or \\>70% obstruction elsewhere in the coronary tree.",[86,87],"ADULT","OLDER_ADULT",[89],{"facility":90,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":106},"University of Colorado Hospital","Aurora","Colorado","80045","United States",[96,101,104],{"name":97,"role":98,"phone":99,"email":100},"Zackry Morgan","CONTACT","720-848-5494","zackry.morgan@cuanschutz.edu",{"name":102,"role":103},"Caitlin Bell, MD","PRINCIPAL_INVESTIGATOR",{"name":105,"role":103},"Sapna Patel, MD",{"lat":107,"lon":108},39.72943,-104.83192,[110],{"name":97,"role":98,"phone":99,"email":100},[112],{"name":102,"affiliation":13,"role":103},[],[],{"nct_id":4,"conditions":116,"biomarkers":120},[117,118,119,19],"Atherosclerosis","Coronary Artery Disease","Coronary Atherosclerosis",[],{"nct_id":4,"found":15,"summary":122,"prompt_version":132},{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This is an interventional study planning to enroll 40 participants. Participants with heart artery disease will be randomly assigned to either usual care or aggressive lipid-lowering therapy.","completed","Aggressive Lipid Lowering Therapy in Melanoma Patients on Immunotherapy","This study is looking at how aggressive lipid-lowering therapy affects heart artery health in people with melanoma who are starting immune checkpoint inhibitors (ICIs) for the first time. ICIs are standard melanoma treatments, but their long-term effects on heart arteries are not fully understood. You would have a special heart scan (coronary computed tomography angiography, CCTA). If the scan shows disease in your heart arteries, you would be randomly assigned to either usual care or an aggressive lipid-lowering therapy. This therapy involves statins (like atorvastatin, rosuvastatin, simvastatin, or pravastatin), possibly with ezetimibe or PCSK9 inhibitors (alirocumab, evolocumab, inclisiran), managed by a heart doctor to achieve very low LDL-C levels (bad cholesterol). The main goal is to see the change in LDL-C over 12 months. This study is for people aged 55 or older.","The main measurement for this study is taken at 12 months after baseline.",133,"You would undergo a coronary computed tomography angiography (CCTA) scan. If eligible, you would receive either usual care or lipid-lowering medications managed by a cardiologist.","Not stated in the trial record.",[],"v2"]