The VIP-VIZA intensive sub-study is a prospective, randomized open label phase 2 study to compare treatment with several prescription medicines with intensive lifestyle program and with ordinary care of individuals with carotid fatty deposits

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2014
INTERVENTION: Pharmaceutical Form: Tablet Pharmaceutical Form: Tablet Pharmaceutical Form: Tablet Pharmaceutical Form: Tablet Pharmaceutical Form: Tablet Pharmaceutical Form: Tablet Pharmaceutical Form: Tablet CONDITION: Cardiovascular disease ‐ established artherosclerosis Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: 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.; 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. 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; Timepoint(s) of evaluation of this end point: 0 (baseline), 6, 12 and 36 months. SECONDARY OUTCOME: 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. 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
Epistemonikos ID: f7801f5103f1487f1458a9f3e453cfbf8a52faa9
First added on: Aug 23, 2024