Cardiovascular disease Circulatory System Cardiovascular disease
Conditions
Interventions
Current interventions as of 11/10/2017:
Statinwise is a randomised, double blind, placebo controlled N-of-1 trial taking place in a primary care setting. The aim is to quantify the occurrence of self-
patients can restart taking the trial medication as soon as possible. Patients are asked to take the treatment at a time of day convenient to them. Capsules should be swallowed whole. Patients are giv
Sponsors
London School of Hygiene and Tropical Medicine
Eligibility
Sex/Gender
All
Age
16 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Adults (aged 16 years and over) 2. Prescribed statin treatment in the last 3 years 3. Stopped OR considering stopping statin treatment due to muscle symptoms 4. Provided fully informed consent
Exclusion criteria
Exclusion criteria: 1. Any previously documented serum alanine aminotransferase (ALT) levels at or above three times the upper limit of normal 2. Have persistent, generalised, unexplained muscle pain (whether associated or not with statin use) and have creatinine kinase (CK) levels greater than 5 times the upper limit of normal 3. Should not be using atorvastatin 20mg daily in the opinion of the general practitioner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Muscle symptoms (pain, weakness, tenderness, stiffness or cramp) reported every 7-week during treatment, measured using the Visual Analogue Score (VAS) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Relationship between individual trial result and patient decision whether to continue statins long term at month 15, measured by checking if a statin prescription was issued by the General Practitioner. | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactKieran Brack
Outcome results
None listed