Statin Immune Study (ImmunoStat)
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|ClinicalTrials.gov Identifier: NCT02984293|
Recruitment Status : Completed
First Posted : December 6, 2016
Last Update Posted : December 3, 2018
Statins are widely used drugs to treat hypercholesterolaemia. In general, they are very safe drugs. However, up to one third of statin users can experience muscle symptoms, which are most commonly mild without any conventional laboratory signs of muscle damage. However, these muscle symptoms can often lead to poor compliance to the cholesterol-lowering therapy, reducing its effectiveness. Recent data has highlighted the potential role of immune system in development of statin-induced muscle pain. Variation in the LILRB5 gene has been associated with statin intolerance. We aim to investigate the impact of LILRB5 genetic variability in tolerability and immune response to atorvastatin in healthy volunteers.
The study is being undertaken at the Tayside Institute for Cardiovascular Research (TICR) in Ninewells Hospital, Dundee. We will recruit participants who have donated a sample to GoSHARE study. The participants will be healthy, and recruited according to their genotype of LILRB5 (information available from GoSHARE). The volunteers will then enter a randomised cross-over study with two treatment periods. During treatment period one, all participants will be commenced on atorvastatin or placebo (a dummy drug). Before and at the end of the treatment period, blood and urine samples will be taken and a muscle symptoms questionnaire will be completed to assess the tolerability and immune response to the study drug exposure. After four weeks, the study drug is stopped for a washout period of three weeks before cross-over commences. Thereafter, during treatment period two, the alternate study drug will be started, and tolerability will be assessed similar to that in period one. The study will last approximately 11 weeks. The volunteers have a total of 5 visits to the TICR.
|Condition or disease||Intervention/treatment||Phase|
|Drug Intolerance||Drug: Atorvastatin Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Impact of LILRB5 Genotype on Immune Response to Atorvastatin|
|Actual Study Start Date :||April 17, 2017|
|Actual Primary Completion Date :||November 3, 2017|
|Actual Study Completion Date :||November 3, 2017|
Active Comparator: Atorvastatin
The participants will receive atorvastatin (80 mg) orally once daily for 28 days.
Atorvastatin 80 mg once daily for 28 days.
Placebo Comparator: Placebo
The participants will receive matched placebo orally once daily for 28 days.
Placebo once daily for 28 days.
- The primary outcome will be the change in CK levels at the end of the treatment from baseline in both treatment periods. [ Time Frame: Measured at baseline (day 0) and day 29 of both treatment periods. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984293
|University of Dundee|
|Dundee, United Kingdom, DD1 9SY|
|Study Chair:||Colin NA Palmer, PhD FSB FRSE||University of Dundee|