Atorvastatin in Factorial with Omega-3 fatty acid Risk Reduction in Diabetes …in an academic collaboration with.
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Atorvastatin in Factorial with Omega-3 fatty acid Risk Reduction in Diabetes …in an academic collaboration with
Trial Design Collaborative academic and pharmaceutical study Funded by Pfizer, with data owned, analysed and reported by the University of Oxford Diabetes Trials Unit (DTU) Multi-centre primary prevention trial in 1,000 patients with type 2 diabetes Double-blind, placebo-controlled 2 x 2 factorial randomisation to Atorvastatin (Lipitor 20 mg/day) Omega 3 PUFA (Omacor 2g/day) 70 UK clinical centres, one year follow-up
Steering Committee Overall responsibility for scientific, professional and operational conduct of the study Diabetes Trials Unit Study Design and Protocol Dev. Co-ordinating Centre Investigator agreements Ethical/regulatory approval Data collection and management Protocol/clinical queries Statistical analysis/publication Pfizer UK Protocol development Regulatory aspects Study medication On-site Monitoring SAE reporting DTU Central Laboratory 70 Clinical Centres Trial Organisation
Aims To determine the: Range of estimated CHD risk levels typically seen in people with type 2 diabetes in UK general practice Proportion whose estimated ten-year CHD risk can be reduced below 15% with a 20 mg of atorvastatin or 1.8 g omega-3 PUFA/day Degree to which atorvastatin and omega-3 PUFA in combination have additive effects Extent to which therapy adherence can be enhanced using a simple behavioural intervention
Inclusion Criteria Aged 18 years and above Have had type 2 diabetes for at least 3 months Not known to have had a cardiovascular event Have provided written informed consent
Exclusion Criteria Taking prescribed lipid lowering therapy Triglycerides ≥8.0 mmol/L Have specific contraindications to atorvastatin or omega-3 PUFA Have participated in a clinical trial within the last 3 months Are pregnant or lactating females
AtorvastatinPlacebo 500 Omega-3 Omega-3 Omega-3(250) Atorvastatin Placebo 500 Placebo Placebo Placebo(250) 5005001,000 Atorvastatin Placebopatients in total Atorvastatin (20 mg ) Omega-3 PUFA (1.8 g) 2 x 2 Factorial Randomisation
Primary Objectives Proportion of subjects whose LDL levels are <2.6 mmol/L at four months Proportion of subjects whose triglycerides are <1.5 mmol/L at four months
Secondary Objectives Proportion of subjects with LDL levels <2.6 mmol/L at one year Proportion of subjects with triglycerides <1.5 mmol/L at one year Proportion (%) of subjects with estimated ten- year CHD risk <15% at 16 weeks and one year Study medication adherence at 16 weeks and at one year Health economic assessment at 16 weeks and at one year
Visit Schedule Visit 1: week-2Recruitment Visit 2: week0Randomisation Visit 3: week16Four month evaluation Visit 4: week18Additional medication* Adherence study Visit 5: week32Routine Follow up Visit 6: week52One year evaluation End of study * Patients whose estimated CHD risk remains greater than 20% at four months will receive an additional tablet containing 20 mg atorvastatin, whilst the remainder will receive an additional placebo tablet, in double-blind fashion.
Study will commence in 2004 One year recruitment in 70 UK practices One year follow-up for all subjects Results expected 2006 Contact: Email: firstname.lastname@example.org@dtu.ox.ac.uk Phone:01865 857 246 Fax:01865 857 256 Web site: www.dtu.ox.ac.uk/aforrd Trial Schedule