Cardiovascular disease - established artherosclerosis
Conditions
Interventions
Pharmaceutical Form: Tablet
Pharmaceutical Form: Tablet
Pharmaceutical Form: Tablet
Pharmaceutical Form: Tablet
Pharmaceutical Form: Tablet
Pharmaceutical Form: Tablet
Pharmaceutical Form: Table
Sponsors
Västerbottens läns landsting
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Inclusion criteria in the VIP-VIZA intensive sub-group study are the same as in the large VIP-VIZA study, i.e., a) age 60 years or b) age 50 years with a family history of early CVD, hypertension, smoking, diabetes, S-LDL cholesterol =4.5 mmol/L and/or obesity or c) age 40 years with family history of early CVD 2) The individuals are: a) living in the catchment of Umeå and b) have a visible carotid plaque and c) in fertile females, willing to comply with effective contraceptive methods up to 3 months after the last study drug administration and d) give informed consent to participate also in this sub-study. 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 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1)Previous known cardiovascular disease 2)Atrial fibrillation 3)Short life expectancy due to other comorbidity 4)Contraindication for or otherwise not compliant with the carotid ultrasound or other investigations 5)Already receiving high-dose statin therapy 6)Documented allergy or intolerance to any of the study drugs without possibility to change to an alternative 7)Severe psychiatric condition or other reason that jeopardize compliance with repeated follow up. 8)On fertile females, pregnancy assessed by anamnesis and/or pregnancy test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: The primary objective of the VIP-VIZA intensive sub-study is to investigate, by means of advanced carotid ultrasound techniques, whether an established atherosclerosis in humans without previously known cardiovascular disease can be alleviated or even eliminated by multimodal cardiovascular prevention. ;Secondary Objective: 1. Changes at baseline vs at 1 and 3 years in a composite of clinical cardiovascular risk factor burden according to the SCORE 2 and the Framingham risk-score 3 system 2. Cardiovascular events during 3 years follow-up: composite of MI, stroke, aortic dissection or cardiovascular death separated MI, stroke, aortic dissection or cardiovascular death 3. Blood chemistry; changes at baseline vs at 6, 12 and 36 months of plasma lipids (total cholesterol, LDL-C, HDL, triglycerides, Lp(a), Apo B: quotient glucose tolerance, glycated hemoglobin (HbA1c) high-sensitive C-reactive protein (hs-CRP) blood pressure and heart rate variability change in central and ambulatory blood pressure, blood pressure and heart rate variability 4. Life style changes reduced stress level smoking cessation dietary changes according to a Mediterranean score physical activity change weight reduction/waist reduction 5. Compliance to treatment - adverse events - compliance to drug prescription ;Primary end point(s): The primary endpoint is to evaluate the effect of treatment on the progression/regression/no-change over time in plaque characteristics and composition as assessed at 0 (baseline), 6, 12 and 36 months by advanced ultrasound techniques.;Timepoint(s) of evaluation of this end point: 0 (baseline), 6, 12 and 36 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: Changes at baseline vs at 1 and 3 years in a composite of clinical cardiovascular risk factor burden according the SCORE 2 and the Framingham risk-score3 system Cardiovascular events during 3 years follow-up: Composite of MI, stroke, aortic dissection or cardiovascular death Separated MI, stroke, aortic dissection or cardiovascular death Blood chemistry; changes at baseline vs at 6, 12 and 36 months of: Plasma lipids (total cholesterol, LDL-C, HDL, triglycerides, Lp(a), Apo B: quotient Glucose tolerance, glycated hemoglobin (HbA1c) High-sensitive C-reactive protein (hs-CRP) Blood pressure and heart rate variability Change in central blood pressure, ambulatory blood pressure, blood pressure variability Changes in heart rate variability Life style changes Reduced stress level Smoking cessation Dietary changes accroding to a Mediterranean score Physical activity change (Metabolic Equivalent of Task, MET) Weight reduction/waist reduction Compliance to treatment Adverse events Compliance to drug prescription ;Timepoint(s) of evaluation of this end point: 0 (baseline), 6, 12 and 36 months. | — |
Countries
Sweden
Contacts
Public ContactClinical Trial Unit
Västerbottens läns landsting
Outcome results
None listed