Cardiovascular Diseases Clinical Trial
— PREVESTATGxOfficial title:
A Multicenter, Controlled, Randomized, Single-blind Phase IV Trial Assesses Efficacy, Safety, and Cost of Pre-emptive Genotyping in a Cardiovascular Risk Population Eligible for High/Moderate-intensity Statins
This is a Phase IV multicentre adaptive single-blinded randomized clinical trial if preemptively genotyping populations at risk of cardiovascular disease susceptible of receiving high or moderate doses of statin therapy is efficacious, cost-efficacious, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol
Status | Not yet recruiting |
Enrollment | 216 |
Est. completion date | March 4, 2025 |
Est. primary completion date | February 10, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Each potential participant must satisfy all of the following criteria to be enrolled in the study: 1. 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. 2. Subject has voluntarily signed the ICF. 3. Subject must be = 18 years old at the time of signing ICF. 4. Subject is able and willing to take part and be followed-up for the majority of the study duration. 5. Participants are susceptible to be prescribed any of the following: 1. Atorvastatin =40 mg/day p.o. 2. Simvastatin =20mg/day p.o. 3. Pitavastatin=2mg/day p.o. 4. Rosuvastatin =40mg/day p.o. 5. Pravastatin =40mg/day p.o. 6. Lovastatin =40mg/day p.o. 7. Fluvastatin =80 mg/day p.o. 6. Subjects must be naïve to any genotyping test of the following genes: SCLO1B1, ABCG2, CYP2C9, CYP3A4, CYP3A5 and HMGCR. 7. Subjects must be willing to comply and adhere to any treatment plan modifications established and to the procedures specified in this protocol. 8. 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: Any potential participant who meets any of the following criteria will be excluded from participating in the study: 1. Subject is currently taking ubiquinone (Q10) supplements. 2. Known personal or family history of statin-associated autoimmune myopathy or HMG-CoA reductase disorder. 3. Pregnant or breastfeeding women 4. Subject has a personal history or analytical evidence of one of the following disorders: 1. Any contraindications to statin administration as revealed in the summary of product characteristics (SmPCs) for statins. 2. Prior SAMS if subject is not statin-naïve. 5. Any condition or situation deemed by the investigator precluding or interfering with the present study. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital La Paz | Madrid | Comunidad De Madrid |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigación Hospital Universitario La Paz | Instituto de Salud Carlos III |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Novel prognostic and predictive genetic biomarkers of statin-related adverse events and efficacy identification | All participants DNA sample will be susceptible of deep sequencing analysis at CNIO (National Centre of Oncological Investigations) to assess novel prognostic and predictive biomarkers for statin induced muscle symptoms such as fibroblast growth factor 21 (FGF21), MicroRNA-499 or IL-6. | Though study completion, on average 18 months | |
Other | Death from cardiovascular causes, nonfatal myocardial infarction or hospitalization for unstable angina or resuscitated cardiac arrest | Combined incidence of participants who experience a 4-component exploratory endpoint consisting of:
Cardiovascular death Nonfatal myocardial infarction (MI) Resuscitated cardiac arrest Hospitalization for unstable angina |
9-months | |
Other | Difference in percentage in the eight-item Morisky Medication Adherence Scale (MMAS-8) questionnaire score between intervention and control arm | A score <6 indicates low adherence A score of 6-8 indicates medium adherence A score >8 indicates high adherence | 9-months | |
Other | SAMS intensity reduction of a statin preemptive pharmacogenetic prescription scheme | Difference in Numeric Pain Rating Scale (NPRS) score between intervention and control arm.
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. |
9-months | |
Primary | Incidence of clinically relevant statin-associated musculoskeletal events | As defined by the a composite endpoint:
Patients with a clinically relevant statin-associated musculoskeletal symptom defined as a combination of a SAMS-CI (Statin Associated Muscular Symptoms Clinical Index) score =7 points and a NPRS (Numerical Pain Rating Scale) score =3) in the 9-month follow-up period Serum creatin phosphokinase (CPK) [UI/L] greater than three times the upper limit of normality prespecified by each centre's laboratory, in relation to the statin. |
9-months | |
Secondary | Low density lipoprotein cholesterol (LDLc) serum concentration baseline reduction rate | Percentage of Baseline LDLc serum concentration reduction rate when compared to LDLc serum concentration values at 9 months. | 9-months | |
Secondary | Baseline change in statin therapy prescription | 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. | 9-months | |
Secondary | Cost of a statin preemptive pharmacogenetic prescription scheme | To quantify economic burden a cost-benefit analysis defined as the difference [in monetary units, euros] between the costs of the intervention [pharmacogenetic analysis] and all its surrounding procedures [personnel, geneticist report, clinical pharmacologist report] combined with the costs derived from the events [blood sample analysis, hospital admission, follow-up visits, lipid-lowering therapy modification] in the intervention arm when compared to the costs derived from the events in the control arm alone
Monetary units requiered to prevent a event will be calculated through an incremental cost effectiveness ratio (ICER) between intervention and control arm . |
Though study completion, on average 18 months |
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