VIP-VIZA intensive multimodal cardiovascular intervention sub-study - a phase 2 randomized controlled trial - VIP-VIZA intensive sub-study

Västerbottens läns landsting0 个研究点开始时间: 2014年6月30日最近更新: 2014年10月7日

试验速览

暂无简介。

•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

•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

发起方

Västerbottens läns landsting