Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Sta… (NCT06262685) | Clinical Trial Compass
UnknownPhase 4
Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins
Spain216 participantsStarted 2024-03-04
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Subject has voluntarily signed the ICF.
✓. Subject must be ≥ 18 years old at the time of signing ICF.
✓. Subject is able and willing to take part and be followed-up for the majority of the study duration.
✓. Participants are susceptible to be prescribed any of the following:
✓. Atorvastatin ≥40 mg/day p.o.
✓. Simvastatin ≥20mg/day p.o.
✓. Pitavastatin≥2mg/day p.o.
Exclusion criteria
✕. Subject is currently taking ubiquinone (Q10) supplements.
✕. Known personal or family history of statin-associated autoimmune myopathy or HMG-CoA reductase disorder.
✕. Pregnant or breastfeeding women
✕. Subject has a personal history or analytical evidence of one of the following disorders:
✕. Any contraindications to statin administration as revealed in the summary of product characteristics (SmPCs) for statins.
What they're measuring
1
Incidence of clinically relevant statin-associated musculoskeletal events
Timeframe: 9-months
Trial details
NCT IDNCT06262685
SponsorInstituto de Investigación Hospital Universitario La Paz