Primary prevention of atherosclerotic disease
Conditions
Interventions
Trade Name: The products to be administered as IMPs are defined as belonging to an ATC group
Pharmaceutical Form: Tablet
Sponsors
Helsinki University Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • a signed informed consent, • age =18 years, • an indication for statin treatment in agreement with Finnish standard treatment guidelines ("käypä hoito"), • a new statin prescription for primary prevention of atherosclerosis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: • a person as defined in sections 7-10§ of the Finnish law on Medical Research (disabled, underage, pregnant, nursing or prisoner), • a contraindication for statin treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effects of genetic variants and other individual factors on statin efficacy, tolerability and concentrations in patients starting a new statin treatment ;Secondary Objective: To investigate the effect of statin therapy on the levels of metabolism-derived products in patients starting a new statin treatment;Primary end point(s): • % change in LDL cholesterol levels (?LDL%), • statin intolerance ;Timepoint(s) of evaluation of this end point: 1 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • adherance • plasma concentrations of statins, their metabolites, and endogenous and nutrition-derived metabolites ;Timepoint(s) of evaluation of this end point: 1 and 12 months | — |
Countries
Finland
Contacts
Public ContactDepartment of Clinical Pharmacology
Helsinki University Central Hospital
Outcome results
None listed