Status:
COMPLETED
MUscle Side-Effects of Atorvastatin in Coronary Patients
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
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 ...
Eligibility Criteria
Inclusion
- 18 years or older
- First or recurrent diagnosis (myocardial infarction) or treatments (Percutaneous Coronary Intervention \[PCI\] or Coronary Artery Bypass Graft operation \[CABG\]) for a coronary heart disease (CHD) event at least 6 months prior to study start and prescribed atorvastatin (irrespective of dose)
- Reporting muscle complaints (i.e. pain, weakness, tenderness, stiffness or cramp) that they attribute to atorvastatin therapy or atorvastatin discontinuation due to muscle complains
- Signed informed consent and expected cooperation of the patient according to International Council for Harmonisation/Good Clinical Practice and national/local regulations
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/ Alanine Aminotransferase \> 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 Creatine Kinase \> 10 times upper limit of the normal range or Alanine Aminotransferase \> 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
Key Trial Info
Start Date :
March 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2019
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT03874156
Start Date
March 5 2019
End Date
December 12 2019
Last Update
January 3 2020
Active Locations (2)
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1
Vestre Viken Trust, Drammen Hospital
Drammen, Buskerud, Norway, 3004
2
Hospital of Vestfold Trust
Tønsberg, Vestfold, Norway, 3103