Myopathy (Statin Associated)NCT01040650
Metabolic Features of Post-Myopathy Patients Associated With Statin Treatment
An observational study of Myopathy (Statin Associated), run by Rockefeller University at 1 site in United States.
Trial summary
Statins are a class of drugs given to lower cholesterol. Although statins are considered to be generally safe, some studies show that about 10% of people on statins develop muscle-related symptoms, from fatigue (tiredness), weakness, cramping, pain and sometimes a lifethreatening muscle breakdown condition known as… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopathy (Statin Associated)
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with statin associated myopathy and normal controls
Who may be able to join
- SAM Group
- Males and females 40-65 yrs old; females must be post-menopause (>12 months since last menstrual period)
- Developed statin-associated myopathy, defined as:
- Documented elevated levels of CPK > 3x upper limit of normal with muscle pain, weakness, cramping during statin treatment, or
- Diagnosed with rhabdomyolysis, or
- Developed muscle pain, weakness, cramping during statin treatment that resulted in statin discontinuation by the subject's MD
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- Developed recurrence of muscle symptoms after resumption of statin treatment, or A score of at least 5/17 on the INQoL on screening on any of the aspects of muscle symptoms (weakness, pain, locking or tiredness) based on subject's recall at the height of the muscle symptoms
- Able to ambulate independently (in order to perform exercise tests)
- Muscle symptoms started/ occurred within one year of starting statin treatment or within one year of changing statin brand or dose adjustment
- Discontinued statins at least 2 months from study inclusion date
- 20% probability of having a cardiovascular (CV) event in the next 10 years calculated using an online CV risk calculator AND with a low or a moderate American College of Sports Medicine (ACSM) risk stratification for a cardiovascular event during a treadmill test
- Normal Control Group
- Age and gender-matched individuals who are not on statins but would otherwise be candidates for statin treatment based on ATP III guidelines and have not experienced severe muscle pain, weakness or cramping at rest or during exercise
- Have not been diagnosed with a myopathy
- Have no family history of a myopathy or age and gender-matched individuals who have previously been on statins and did not develop muscle side effects, and have been off statins (for other than medical reasons) for at least 2 months from study inclusion
- 20% probability of having a cardiovascular (CV) event in the next 10 years calculated using an online CV risk calculator AND with a low or a moderate American College of Sports Medicine (ACSM) risk stratification for a cardiovascular event during a treadmill test
Who cannot join
- Applies to both groups of subjects
- Current treatment with other lipid-lowering agents, or intake of red yeast rice
- Impaired liver or kidney function ( ALT or AST 3x upper limit of normal, creatinine 3x upper limit of normal)
- Untreated hypo or hyperthyroidism
- Documented history of muscle disorder or myopathy other than statin-associated myopathy or previous history of elevated CPK prior to statin exposure
- Anemia (Hb< 110 g/dL)
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- Cancer
- Known diabetes or fasting blood glucose >126 mg/dL
- HIV-1 infection
- Uncontrolled blood pressure 130/80 on two anti-hypertensive drugs
- Currently taking beta blockers
- Known coronary artery disease or peripheral vascular disease
- Chronic illnesses such as lupus, rheumatoid arthritis, psoriasis
- Long term oral, nasal, or inhaler steroid use > 6 months
- On Hormone Therapy except for thyroid replacement
- Alcohol consumption 40 g/day (3 glasses/day wine or beers or binge drinking 4 glasses/night)
- Surgery in the past 6 months except for minor excision/incision procedures, 12-L electrocardiogram demonstrating old/new myocardial infarction/ ischemia or other findings that, at the investigators' discretion, may put the subject at high risk
- Cognitive impairment that prevents comprehension of questionnaires
- Inability to read English (questionnaire language)
- Body mass index > 30 kg/m2
- Physical disability or previous injury that prevents safe exercise testing
- Not eligible for MRS (attachment)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
Statins are a class of drugs given to lower cholesterol. Although statins are considered to be generally safe, some studies show that about 10% of people on statins develop muscle-related symptoms, from fatigue (tiredness), weakness, cramping, pain and sometimes a lifethreatening muscle breakdown condition known as rhabdomyolysis. In some, these symptoms may greatly affect their daily activities. One consideration why symptoms develop in only some patients is that they may have an underlying problem in the way their muscles use fats to produce energy. In these patients, the muscles are not able to fully utilize fats and so they become tired more easily. Fat within the muscle can also affect how your body uses a hormone called insulin, which affects your blood sugar levels. The investigators are specifically interested in previous statin users and determine if the muscle symptoms are related to changes in energy and sugar use. We propose to enroll patients who have developed muscle side effects on previous statin treatment and have since discontinued statin treatment.
Our aim is to compare the metabolic parameters in these patients to age and gender-matched normal individuals.
- Conditions
- Myopathy (Statin Associated)
- Medical subject headings
- Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Controls | Normal Controls | |
| Statin associated myopathy | subjects with statin associated myopathy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Principal Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopathy (Statin Associated)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040650
- Sponsor's protocol ID
- PAM-0672
- Status last verified
- Aug 2013
- First submitted
- 24 Dec 2009
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Features of Post-Myopathy Patients Associated With Statin Treatment
- ClinicalTrials.gov ID
- NCT01040650
- Acronym / sponsor ID
- PAM-0672
- Conditions
- Myopathy (Statin Associated)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator left institution
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 29 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Statins are a class of drugs given to lower cholesterol. Although statins are considered to be generally safe, some studies show that about 10% of people on statins develop muscle-related symptoms, from fatigue (tiredness), weakness, cramping, pain and sometimes a lifethreatening muscle breakdown condition known as rhabdomyolysis. In some, these symptoms may greatly affect their daily activities. One consideration why symptoms develop in only some patients is that they may have an underlying problem in the way their muscles use fats to produce energy. In these patients, the muscles are not able to fully utilize fats and so they become tired more easily. Fat within the muscle can also affect how your body uses a hormone called insulin, which affects your blood sugar levels. The investigators are specifically interested in previous statin users and determine if the muscle symptoms are related to changes in energy and sugar use. We propose to enroll patients who have developed muscle side effects on previous statin treatment and have since discontinued statin treatment.
Our aim is to compare the metabolic parameters in these patients to age and gender-matched normal individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Controls | – | –Normal Controls |
| Statin associated myopathy | – | –subjects with statin associated myopathy |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with statin associated myopathy and normal controls
Key inclusion criteria (16 listed)
- SAM Group
- Males and females 40-65 yrs old; females must be post-menopause (>12 months since last menstrual period)
- Developed statin-associated myopathy, defined as:
- Able to ambulate independently (in order to perform exercise tests)
- Muscle symptoms started/ occurred within one year of starting statin treatment or within one year of changing statin brand or dose adjustment
Key exclusion criteria (22 listed)
- Applies to both groups of subjects
- Current treatment with other lipid-lowering agents, or intake of red yeast rice
- Impaired liver or kidney function ( ALT or AST 3x upper limit of normal, creatinine 3x upper limit of normal)
- Untreated hypo or hyperthyroidism
- Documented history of muscle disorder or myopathy other than statin-associated myopathy or previous history of elevated CPK prior to statin exposure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Principal Investigator left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopathy (Statin Associated), run by Rockefeller University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2013.