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

Phase 1

• Conditions: 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-risk of developing cardiovascular disease.

• Registration Number: EUCTR2009-014913-28-GB
• Lead Sponsor: ondon School of Hygiene & Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-09
• Study Completion: 2012-07-01
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified