Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03874156
Study type Interventional
Source Vestre Viken Hospital Trust
Contact
Status Completed
Phase Phase 4
Start date March 5, 2019
Completion date December 12, 2019

See also
  Status Clinical Trial Phase
Completed NCT04986241 - The Association of Statins on Cardiorespiratory Fitness and Exercise Adaptation
Recruiting NCT04499859 - Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI Phase 4
Completed NCT03001076 - Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility) Phase 3
Completed NCT02988115 - Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant Phase 3
Recruiting NCT05332158 - Medicines Gaps Study N/A
Not yet recruiting NCT06381947 - Efficacy and Safety of Bempedoic Acid in Association With Anti-PCSK9 and Ezetimibe in Statin-intolerant Patients Phase 4
Not yet recruiting NCT06262685 - Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins Phase 4
Completed NCT05806723 - Effects of High Intensity Statin Therapy on Steroid Hormones and Vitamin D in Type 2 Diabetic Men Phase 4
Active, not recruiting NCT03653663 - NIRS to Diagnose SAMS Phase 4
Completed NCT02993406 - Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo Phase 3
Recruiting NCT04069598 - Statin Intolerance in Patients With Myocardial Infarction
Completed NCT04453735 - MUscle Side-Effects of Atorvastatin in Coronary Patients (MUSE) -Follow-up Study Phase 4
Terminated NCT04507373 - 7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin Associated Adverse Muscle Events Phase 4