Table of contents

• Overview of the Rosuvastatin trials
• Trials on cardiovascular prevention
• Trials on lipid lowering and treatment goals
• Trials in special populations
• Comparison and combination studies
• Main endpoints used in the studies
• Study phases and what they mean

Overview of the Rosuvastatin trials

The trial data show that Rosuvastatin is being studied in many different settings, mostly for people with heart and blood vessel risk or high cholesterol-related conditions.^[1][2][3] Most studies are Phase 3 trials, which means they are large studies designed to check how well a treatment works and how safe it is in real patients.^[1][4] There is also a Phase 1 study in healthy volunteers and a Phase 4 study looking at coronary plaque changes after short-term treatment.^[5][6]

Across the trials, Rosuvastatin is used alone, compared with other statins, or studied as part of combination treatment with other lipid-lowering medicines.^[3][7] The main goal is usually to lower LDL cholesterol, reduce major cardiovascular events, or help patients reach a treatment target.^[2][8]

Trials on cardiovascular prevention

Several studies focus on preventing serious heart and brain events in people who already have vascular disease or a high risk of future events.^[4][9] In the large NCT05030428 study, participants with atherosclerotic cardiovascular disease and LDL-C at or above 1.8 mmol/L are included, and Rosuvastatin 40 mg is part of the background treatment in the trial design.^[9] The main endpoint is time to the first cardiovascular death, non-fatal heart attack, or non-fatal ischemic stroke, which is called 3P-MACE.^[9]

Another large prevention trial, NCT06820086, studies people with high polygenic risk for coronary artery disease.^[4] This trial compares preventive statin treatment, including Rosuvastatin 10 mg and 20 mg, with the goal of reducing major cardiovascular events and death over time.^[4] The primary endpoint measures the time to the first major adverse cardiovascular event, including ischemic heart disease, stroke or transient ischemia, peripheral vascular occlusion, revascularization, or cardiovascular death.^[4]

The 2025-521452-30-01 study focuses on people with covert brain infarction, meaning silent brain infarctions that may not cause clear symptoms.^[1] Rosuvastatin appears in the treatment options together with antiplatelet medicines, and the trial asks whether adding antiplatelet and/or statin treatment to risk factor management gives long-term benefit.^[1] The main efficacy endpoint is MACCE at 3 years, and the main safety endpoint is fatal or major bleeding at 36 months.^[1]

Trials on lipid lowering and treatment goals

Many trials use Rosuvastatin to study how well LDL cholesterol can be lowered in people with hyperlipidemia, hypercholesterolemia, dyslipidaemia, or mixed dyslipidaemia.^{[2][3][7][10]} In the 2023-504914-31-00 LEASH study, high-risk patients are treated with Rosuvastatin alone or with ezetimibe, and the trial measures the proportion of patients who reach their LDL-C goal after 12 weeks.^[7] The target depends on cardiovascular risk: very high-risk patients must achieve both a 50% LDL-C reduction and LDL-C below 55 mg/dL, while high-risk patients must achieve both a 50% reduction and LDL-C below 70 mg/dL.^[7]

The 2024-514289-38-00 trial compares a fixed-dose combination of Rosuvastatin 20 mg and fenofibrate 160 mg with Pravafenix® in patients with mixed dyslipidaemia.^[3] Its main outcome is the mean percent change in LDL cholesterol from baseline to week 12.^[3] This means the study is not only asking whether treatment works, but also whether one combination lowers LDL better than the other in a short treatment period.^[3]

The 2024-511263-28-00 study looks at people with hypercholesterolemia who are already on individually optimized lipid-lowering therapy.^[10] Rosuvastatin 40 mg is part of the background treatment, and the trial asks whether adding inclisiran helps more people reach their personal LDL-C target by day 90.^[10] The target used in the study is either below 55 mg/dL or below 70 mg/dL, depending on the participant’s risk profile.^[10]

Trials in special populations

Some trials focus on groups with special needs or higher vulnerability. In 2024-517343-31-00, the population includes frail older adults aged 70 years and above who recently had an ischemic stroke or transient ischemic attack.^[6] The study compares starting statin therapy versus no statin therapy and measures MACE-free survival and health-related quality of life over two years.^[6] Rosuvastatine Viatris 5 mg is one of the statin options listed in the trial.^[6]

The 2024-514523-42-00 PICOLO-FH trial studies children and adolescents with heterozygous familial hypercholesterolemia.^[11] Rosuvastatin 10 mg is used as standard therapy, and the study compares it with Rosuvastatin plus alirocumab or Rosuvastatin plus inclisiran.^[11] The main goal is to see how many participants reach LDL-C below 100 mg/dL after 104 weeks of treatment.^[11]

The 2023-509418-12-00 study includes patients at risk of cardiovascular disease who are suitable for high- or moderate-intensity statin doses.^[8] Rosuvastatina ratiopharm 20 mg is one of the statins studied, and the trial examines a preemptive genotyping strategy, meaning a genetic test used before treatment to help reduce muscle-related side effects linked to statins.^[8] The primary outcome combines clinically relevant muscle symptoms and elevated CPK, a muscle enzyme that can rise when muscles are affected.^[8]

Comparison and combination studies

Some studies compare Rosuvastatin with other statins or with other lipid-lowering strategies. The 2024-516967-10-00 trial in hyperlipidemia includes Rosuvastatin 40 mg and 80 mg among several cholesterol-lowering drugs and asks whether these treatments change sex steroid levels.^[2] This is a different type of study because it does not mainly focus on LDL lowering, but on the relationship between cholesterol-lowering drugs and hormone levels.^[2]

The 2024-511076-32-00 VICTORION-CHALLENGE trial compares inclisiran with bempedoic acid in participants with atherosclerotic cardiovascular disease, while Rosuvastatin 40 mg is part of the standard background therapy.^[12] The main endpoint is percent change in LDL-C at day 150.^[12] In this way, Rosuvastatin is being used as part of the usual treatment base while researchers test whether adding another medicine gives better LDL lowering.^[12]

The NCT05360446 V-PLAQUE study includes people with non-obstructive coronary artery disease and no previous cardiovascular events.^[13] Participants receive maximally tolerated statin therapy, including Rosuvastatin 40 mg or atorvastatin 80 mg, and the study measures total coronary atheroma volume at month 24.^[13] The aim is to see whether adding inclisiran can reduce plaque burden more than placebo on top of statin treatment.^[13]

The NCT06603363 INTENSE study is a Phase 4 coronary CT study in people with coronary artery disease and stable chest pain.^[5] It compares placebo with Xeter 10 mg filmtabletta, and the main outcome is non-calcified plaque volume after 3 months.^[5] This type of measurement looks at plaque that is not yet hardened by calcium and can help show short-term changes in the artery wall.^[5]

Main endpoints used in the studies

The trials use several main endpoints, depending on the question being asked.^{[1][3][4][6][9][10][11][12][13]}

• LDL-C change: several studies measure how much LDL cholesterol falls after treatment, often at 12 weeks, 90 days, or 150 days.^{[3][7][10][12]}
• Major cardiovascular events: some trials measure heart attack, stroke, cardiovascular death, or a combined outcome such as MACE or MACCE.^[1][4][6][9]
• Plaque volume: imaging studies assess coronary plaque size, including non-calcified plaque or total atheroma volume.^[5][13]
• Safety outcomes: some studies track major bleeding, fatal bleeding, or muscle-related problems.^[1][8]
• Quality of life: the frail older adult trial measures health-related quality of life using PROMIS-10.^[6]
• Special biological measures: one trial studies sex steroid levels, while another looks at relative bioavailability in healthy volunteers.^[2][14]

Study phases and what they mean

Most Rosuvastatin trials in this dataset are Phase 3 studies, which usually means they involve larger groups and compare treatment strategies in real patient populations.^{[1][3][4][6][7][8][9][10][11][12][13]}

The Phase 1 bioequivalence study in healthy volunteers tested two formulations of rosuvastatin/ezetimibe and measured exposure values such as AUC and Cmax.^[14] Bioequivalence means the two products behave similarly in the body, which is important before a generic or alternative formulation is used more widely.^[14]

The Phase 4 INTENSE study looks at plaque changes after short-term statin therapy in a more routine clinical setting.^[5] This helps researchers understand what happens in everyday practice after treatment has already been introduced into care.^[5]