N/A N=22 Randomized Triple-blind Diagnostic

Evaluation of Ubiquinol on Mitochondrial Oxidative Capacity in Statin Patients Using 31PMRS

Myopathy · HMG COA Reductase Inhibitor Adverse Reaction · Hypercholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT01702987 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Phosphocreatine Recovery — -18.9; 7.7 percentage change from baseline

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ubiquinol (Dietary_supplement); placebo (Dietary_supplement); statin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Beth Israel Deaconess Medical Center
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Phosphocreatine Recovery	-18.9; 7.7	—

Summary

It is our primary hypothesis that statin drugs impair skeletal muscle mitochondrial function and that ubiquinol (the reduced active form of CoQ10) supplementation will block impairment of PCr recovery kinetics in patients using statins. The investigators propose a pilot study to extend our research to examine PCr recovery kinetics in 20 statin users randomized in a parallel arm study to either ubiquinol or placebo over 4 weeks.

Eligibility Criteria

Inclusion Criteria

Persons age 18 years and older who have been advised to use a statin medication by their physician.
Up to ten individuals will have a history of statin myalgia on observed statin rechallenge. All others will have a history (>6 months) of tolerating a statin at a standard starting dose or higher.
All persons will be able to cooperate for a period of 1-2 hours, able to provided informed consent and have no known adverse effects or contraindications to an MRI study.

Exclusion Criteria

Having diabetes or known lower extremity peripheral vascular disease, as these conditions may interfere with interpretation of the MRI spectroscopy of the lower extremity (the only site we are examining in this study).
Current users of a statin with a recent heart attack, stroke, or revascularization procedure (within the last 1 year) who could be at higher risk of stopping a statin.
Creatine kinase (CK) > 5 x ULN. If CK levels are greater than 3 x ULN, the participant will be given the option of returning for a repeat blood draw at their earliest convenience. Any elevation in CK will be treated per the safety guidelines outlined in section B5.
Alanine transferase (ALT) or aspartate transferase (AST) > 3 x ULN. If ALT and/or AST levels are greater than 3 x ULN, the participant will return for a repeat blood draw at their earliest convenience. If the participant's ALT and/or AST is found elevated at this repeat analysis, they will be withdrawn from the study. Any elevation in ALT and/or AST will be treated per the safety guidelines outlined in section B5.
Severe uncontrolled medical problems or medications that may influence measurements or impair ability to participate in the study exams (e.g. poorly controlled hypertension; (>170/>100); known creatinine > 2.5 md/dl or GFR < 30; anemia with Hgb < 10, etc.).
Pregnancy or breastfeeding (a contraindication for statin use)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01702987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.