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.

Conditions: Cardiovascular disease - established artherosclerosis
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2014-001895-72-SE

Lead Sponsor: Västerbottens läns landsting

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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