RETRO-PRO: The effectiveness of simvastatin compared to atorvastatin: an e-clinical randomised trial within a research database in routine clinical practice - a feasibility study - RCTs within the database: a feasibility study of statin effectiveness

ondon School of Hygiene & Tropical Medicine0 个研究点目标入组 300 人开始时间: 2010年6月9日最近更新: 2019年6月30日

适应症

试验速览

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•Study inclusion criteria
•(i)Age 40 or over
•(ii)Able and willing to provide informed consent to study participation
•(iii)Fully registered with the general practice for at least 6 months (i.e. subjects who are newly registered with the practice will not be eligible)
•(iv)Subjects who had not been prescribed a statin previously
•(v)Subjects who in the opinion of the GP Investigator should be prescribed a statin
•(vi)Subjects who in the opinion of the GP Investigator have primary hypercholesterolaemia (cholesterol of 5.0 mmol/l or above) and have not responded adequately to diet or other appropriate measures (i.e. one of licensed indications of statins)
•(vii)Subjects who in the opinion of the GP Investigator would require a statin for primary prevention according to the 2008 NICE guideline on lipid modification: adults over 40 who have a 20% or greater 10-year risk of developing cardiovascular disease, based on Framingham 1991 10-year risk equations and clinical judgement
•Further details can be found in the British National Formulary (section 2.12) and in the 2008 NICE guideline on lipid modification [5], which will be available on the study website.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Study exclusion criteria
•Statins are contra-indicated in active liver disease (or persistently abnormal liver function tests), in pregnancy (adequate contraception required during treatment and for 1 months afterwards) and breast-feeding. Further details can be found in the British National Formulary (section 2.12)

发起方

ondon School of Hygiene & Tropical Medicine