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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
Sponsor:
Collaborator:
NHS Tayside
Information provided by (Responsible Party):
University of Dundee

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Atorvastatin
The participants will receive atorvastatin (80 mg) orally once daily for 28 days.
Drug: Atorvastatin
Atorvastatin 80 mg once daily for 28 days.

Placebo Comparator: Placebo
The participants will receive matched placebo orally once daily for 28 days.
Drug: Placebo
Placebo once daily for 28 days.




Primary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 40-69 years
  • Statin-naïve
  • White European
  • Healthy
  • Acceptable laboratory test results

Exclusion Criteria:

  • Significant disease
  • Regular drug therapy
  • Recent involvement (<30 days) in a CTIMP
  • Inability/unwillingness to comply with the protocol
  • Carry the rare variant of the CKM polymorphism rs11559024
  • Unable to consent
  • Woman of childbearing potential (i.e. premenopausal female capable of becoming pregnant)

Information from the National Library of Medicine

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


Locations
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United Kingdom
University of Dundee
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
NHS Tayside
Investigators
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Study Chair: Colin NA Palmer, PhD FSB FRSE University of Dundee
Publications:
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Responsible Party: University of Dundee
ClinicalTrials.gov Identifier: NCT02984293    
Other Study ID Numbers: 2016CV05
16/ES/0128 ( Other Identifier: East of Scotland Research Ethics Service )
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: As per GoSHARE tissue bank protocol, the data derived from the existing samples will be returned to the tissue bank for research use.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Dundee:
Atorvastatin
LILRB5
Statin intolerance
Additional relevant MeSH terms:
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Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors