Status:
COMPLETED
MUscle Side-Effects of Atorvastatin in Coronary Patients (MUSE) -Follow-up Study
Lead Sponsor:
Vestre Viken Hospital Trust
Collaborating Sponsors:
The Hospital of Vestfold
Oslo University Hospital
Conditions:
Statin Adverse Reaction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Statins are cornerstone treatment in secondary cardiovascular disease (CVD) prevention. Today, statin non-adherence (patients not taking their prescribed drug) remains a major public health concern, l...
Eligibility Criteria
Inclusion
- Participation in the MUSE trial (Eudract nr. 2018-004261-14) and still fulfilling the study entry criteria: First or recurrent diagnosis (myocardial infarction) or treatments (PCI or CABG) for a CHD event 12-42 months prior to study start.
Exclusion
- First or recurrent diagnosis (myocardial infarction) or treatments (PCI or CABG) for a CHD event the a) past 12 months prior to study start in high risk patients (i.e. at least one of following comorbid conditions: systolic heart failure, \>1 previous myocardial infarction, kidney failure, diabetes, and smokers) and b) the past 6 months prior to study start in low risk patients without any of the co-morbid conditions mentioned above and in patients who are not taking a statin at all.
- Patients with symptomatic peripheral artery disease and patients with familial hypercholesterolemia
- Patient has any contraindications for atorvastatin listed in the Summary of Product Characteristics (i.e. known hypersensitivity to the ingredients, acute liver failure/ ALT \> 3 times upper limit of the normal range in blood at study start, pregnancy and breastfeeding )
- History of previous rhabdomyolysis, myopathy or liver failure due to statin treatment with CK \> 10 times upper limit of the normal range or ALT \> 3 times upper limit of the normal range.
- Any condition (e.g. psychiatric illness, dementia) or situation, that in the investigator's opinion could put the subject at significant risk, confound the study results, interfere significantly with the subject participation in the study, or rendering informed consent unfeasible
- Short life expectancy (\<12 months) due to other medical conditions
- Not being able to understand Norwegian.
- Women of childbearing potential defined as all premenopausal female.
- Participation in another randomized clinical trial
- Classified with significantly more muscle symptoms on placebo than on atorvastatin in the MUSE trial
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04453735
Start Date
August 19 2020
End Date
December 18 2020
Last Update
February 26 2021
Active Locations (2)
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1
Vestre Viken HF, Drammen Hospital
Drammen, Buskerud, Norway, 3004
2
Hospital of Vestfold
Tønsberg, Vestfold, Norway, 3103