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STATIN: Web-based Investigation of Side Effects (STATINWISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02781064
Recruitment Status : Completed
First Posted : May 24, 2016
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:

Statins are known to cause rare but serious side effects such as rhabdomyolysis (breakdown of muscle tissue) but many patients stop taking statins due to less severe symptoms, such as muscle pain or fatigue.

This study aims to determine whether symptoms occurring during statin use are caused by statins. The trial will compare patient-reported side effects of statins (20mg atorvastatin) vs. placebo.

Patients will be randomized to alternating treatment blocks of either statin or placebo split into six two-month treatment periods. At the end of each period, patients will be asked to self-report side effects using a website or mobile app.


Condition or disease Intervention/treatment Phase
Cardiovascular Disease Drug: Atorvastatin 20mg Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blinded IMP
Primary Purpose: Other
Official Title: A Series of Randomised Controlled N-of 1 Trials in Patients Who Have Discontinued or Are Considering Discontinuing Statin Use Due to Muscle-related Symptoms to Assess if Atorvastatin Treatment Causes More Muscle Symptoms Than Placebo
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : August 8, 2019
Actual Study Completion Date : August 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Atorvastatin 20mg
Atorvastatin to be taken daily in 2 month treatment periods, 3 treatment periods in 12 months
Drug: Atorvastatin 20mg
Atorvastatin and matching placebo to be taken in a randomised order for 12 months
Other Name: Lipitor, Atorva

Drug: Placebo
Atorvastatin and matching placebo to be taken in a randomised order for 12 months
Other Name: Microcrystalline Cellulose

Placebo Comparator: Placebo - Microcrystalline Cellulose
Placebo to be taken daily in 2 month treatment periods, 3 treatment periods in 12 months
Drug: Atorvastatin 20mg
Atorvastatin and matching placebo to be taken in a randomised order for 12 months
Other Name: Lipitor, Atorva

Drug: Placebo
Atorvastatin and matching placebo to be taken in a randomised order for 12 months
Other Name: Microcrystalline Cellulose




Primary Outcome Measures :
  1. Muscle Symptoms [ Time Frame: Every 8 weeks for 12 months in total ]
    Patient reported muscle symptoms (pain, weakness, tenderness, stiffness or cramp).


Secondary Outcome Measures :
  1. Patient belief of statin effects, medication adherence [ Time Frame: at 15 months post randomisation ]
    Relationship between individual trial result and patient decision whether to continue statins long term.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (aged 16 and over)
  • Prescribed statin treatment in the last 3 years
  • Stopped OR considering stopping statin treatment due to muscle symptoms
  • Provided fully informed consent.

Exclusion Criteria:

  • Any previously documented serum alanine aminotransferase (ALT) levels at or above three times the upper limit of normal;
  • 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
  • Any contraindications listed in the IMP SPC
  • Should not be using atorvastatin 20mg daily in the opinion of the general practitioner.

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): NCT02781064


Locations
Show Show 58 study locations
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
National Institute for Health Research, United Kingdom
Investigators
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Study Director: Haleema Shakur, RN London School of Hygiene and Tropical Medicine
  Study Documents (Full-Text)

Documents provided by London School of Hygiene and Tropical Medicine:
Study Protocol  [PDF] June 28, 2017
Informed Consent Form  [PDF] June 27, 2017
Statistical Analysis Plan  [PDF] August 6, 2019


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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02781064    
Other Study ID Numbers: ISRCTN30952488
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors