Cardiovascular illness Circulatory System Complications and ill-defined descriptions of heart disease
Conditions
Interventions
Potentially eligible trial subjects will be "anonymously" identified by the Principal Investigator within the anonymous GPRD records. To ensure patients who are eligible under statin SPCs and the guid
Sponsors
University of Liverpool (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 40 years or over, either sex 2. Able and willing to provide informed consent to study participation 3. 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) 4. Subjects who had not been prescribed a statin previously 5. Subjects who in the opinion of the GP Investigator should be prescribed a statin 6. 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) 7. 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.
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Methodological endpoint evaluating the feasibility of conducting RCTdb 2. Clinical endpoint evaluating the percent change of total cholesterol, high-density lipoprotein cholesterol (HDL) and low-density lipoprotein cholesterol (LDL), comparing the baseline values to a repeat measurement within 3 months The feasibility evaluation will include the recruitment rate of GPs and of subjects and an assessment of the technical challenges in conducting RCTdb. No formal threshold for success will be applied but results will be published. The blood samples for total cholesterol, HDL, and LDL should be taken at the same time as the routine blood samples. The 2008 guideline on lipid modification from NICE and the National Collaborating Centre for Primary Care recommends that fasting total cholesterol, HDL, fasting blood glucose, liver function tests and renal function are measured prior to start of statin treatment. In addition, a repeat liver function test is recommended to be done within 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Persistence to statin treatment at month 3 2. Myocardial infarction 3. Stroke 4. Death (any cause) 5. Death with cardiovascular disease as primary cause 6. Feasibility of collecting biological samples in RCTdb Given the small number of subjects in this study, these secondary outcomes will serve as pilot data for power calculations for larger studies in the future. The study will not be powered statistically to detect a difference between simvastatin and atorvastatin in the rate of secondary outcomes. | — |
Countries
United Kingdom
Outcome results
None listed