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MUscle Side-Effects of Atorvastatin in Coronary Patients

NCT03874156 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2020-01-03

No results posted yet for this study

Summary

The study aims to estimate the effect of atorvastatin on muscular symptom intensity in coronary patients with subjective statin-associated muscle symptoms (SAMS) and to determine the association with blood levels of atorvastatin and its metabolites, to obtain an objective marker for true SAMS. A randomized study will include 80 coronary patients with SAMS during ongoing atorvastatin therapy or previous muscle symptoms that led to discontinuation of atorvastatin. Patients will be randomized to 7-weeks treatment with atorvastatin 40 mg/day in the first period and matched placebo in the second 7-weeks period, or placebo in the first period and atorvastatin in the second period. A control group (n=40) without muscle symptoms will have 7 weeks open treatment with atorvastatin 40 mg/day. Blood samples will be collected at baseline and after each treatment period, and muscular symptom intensities will be rated by the patients weekly. The primary outcome is the difference in aggregated mean Visual Analogue Scale (VAS) scores between the last three weeks of atorvastatin treatment and of placebo treatment. The main purpose is to develop an objective marker for true SAMS, by comparing SAMS associated with blinded atorvastatin treatment with blood concentrations of atorvastatin and its metabolites. Diagnostic and discrimination performance will be determined. The study provides new clinical knowledge on SAMS in coronary patients and may contribute to more personalized statin treatment and monitoring, fewer side-effects and consequently improved adherence and lipid management in future practice.

Conditions

  • Statin Adverse Reaction

Interventions

DRUG

Atorvastatin 40mg

Oral tablet fabricated and labelled at Krageroe Tablettproduksjon AS

DRUG

Placebo Oral Tablet

Oral tablet fabricated and labelled at KrageroeTablettproduksjon AS

Sponsors & Collaborators

  • The Hospital of Vestfold

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • Vestre Viken Hospital Trust

    lead OTHER

Principal Investigators

  • john munkhaugen, MD, PhD · Vestre Viken Trust

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-05
Primary Completion
2019-12-12
Completion
2019-12-12

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03874156 on ClinicalTrials.gov