ROSUVASTATIN for Cardiovascular disease

Stratification factors

• Subject's centre
• Concomitant treatment with non-statin lipid lowering therapies
• Primary versus secondary prevention

Inclusion criteria

• {"criterion_text":"- Ability of the participant to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.\n- Subject has voluntarily signed the ICF.\n- Subject must be ≥ 18 years old at the time of signing ICF.\n- Subject is able and willing to take part and be followed-up for the majority of the study duration.\n- Participants are susceptible to be prescribed any of the following: a. Atorvastatin ≥40 mg/day p.o. b. Simvastatin ≥20mg/day p.o. c. Pitavastatin≥2mg/day p.o. d. Rosuvastatin ≥40mg/day p.o. e. Pravastatin ≥40mg/day p.o. f. Lovastatin ≥40mg/day p.o. g. Fluvastatin ≥80 mg/day p.o.\n- Subjects must be naïve to any genotyping test of the following genes: SCLO1B1, ABCG2, CYP2C9, CYP3A4, CYP3A5 and HMGCR.\n- Subjects must be willing to comply and adhere to any treatment plan modifications established and to the procedures specified in this protocol.\n- Women of childbearing potential must commit not to become pregnant. Subjects must be willing to use highly effective contraceptive methods or have practiced sexual abstinence during the study."}

Exclusion criteria

• {"criterion_text":"- Subject is currently taking ubiquinone (Q10) supplements.\n- Known personal or family history of statin-associated autoimmune myopathy or HMG-CoA reductase disorder.\n- Pregnant or breastfeeding women\n- Subject has a personal history or analytical evidence of one of the following disorders: a. Any contraindications to statin administration as revealed in the summary of product characteristics (SmPCs) for statins. b. Prior SAMS if subject is not statin-naïve.\n- Any condition or situation deemed by the investigator precluding or interfering with the present study."}

Primary endpoints

• {"endpoint_text":"- A composite variable that includes the incidence of patients with a clinically relevant statin-associated musculoskeletal symptom (defined as a combination of a SAMS-CI score ≥7 and a NPRS score ≥3) in the 9-month follow-up period or a serum CPK greater than three times the upper limit of normality prespecified by each centre’s laboratory, related to the statin.","definition_or_measurement_approach":"Composite endpoint defined as (1) SAMS-CI score ≥7 AND NPRS score ≥3 during 9-month follow-up OR (2) serum CPK > 3x upper limit of normal as specified by each centre's laboratory, related to statin."}

Secondary endpoints

• {"endpoint_text":"- 9-month change in percentual LDLc defined as the percentage difference between LDLc values at 9 months minus baseline LDLc.","definition_or_measurement_approach":"Calculated as percentage difference between LDLc at 9 months and baseline LDLc."}
• {"endpoint_text":"- Percentage of patients that require either a statin dose modification/withdrawal or additional lipid-lowering therapy after 9 months in order to meet LDLc goals.","definition_or_measurement_approach":"Proportion of participants requiring statin dose change/withdrawal or additional lipid-lowering therapy by 9 months to meet LDLc targets."}
• {"endpoint_text":"- The difference between the costs of the intervention and all its surrounding procedures combined with the costs derived from the events in the intervention arm when compared to the costs derived from the events in the control arm alone over the 9-month follow-up period. Additionally, the ratio between cost differences and efficacy differences between both arms may be calculated.","definition_or_measurement_approach":"Health economic comparison of intervention vs control costs over 9 months; may include calculation of cost-effectiveness ratio (cost differences relative to efficacy differences)."}
• {"endpoint_text":"- Novel prognostic and predictive genetic biomarkers of statin-related adverse events and efficacy will be assessed in outlier subject’s/or any given subject for quality control reasons trough techniques not readily available at all centres, and only available at CNIO as well as genome-wide association studies when applicable. Aforementioned techniques may vary at CNIOs criteria and may include (but are not limited to) assays and/or next generation sequencing techniques.","definition_or_measurement_approach":"Assessment of novel prognostic/predictive genetic biomarkers using advanced assays and/or next generation sequencing at CNIO and GWAS when applicable."}
• {"endpoint_text":"- Percentage of participants who experience a 4-component exploratory endpoint consisting of cardiovascular death, nonfatal myocardial infarction (MI), resuscitated cardiac arrest, or hospitalization for unstable angina","definition_or_measurement_approach":"Proportion experiencing any of the four cardiovascular events (CV death, nonfatal MI, resuscitated cardiac arrest, hospitalization for unstable angina) during follow-up."}
• {"endpoint_text":"- Difference in Morisky-Green (MMAS-8) questionnaire adherence levels/score between both study arms.","definition_or_measurement_approach":"Difference in MMAS-8 adherence scores between intervention and control arms."}
• {"endpoint_text":"- Difference in Numeric Pain Rating Scale (NPRS) score between both study arms. Categories will be as follow: 0-3 no pain; 3-5 moderate pain; 5-7 intense pain; 7-9 very intense pain; 9-10 extreme pain.","definition_or_measurement_approach":"Comparison of NPRS scores between arms; NPRS categories defined as provided."}

Spain

Earliest CTIS Part Ii Submission Date

15-04-2024

Latest Decision Or Authorization Date

13-11-2025

Processing Time Days

577

Number Of Sites

11

Number Of Participants

216

Primary sponsor

Full Name

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain