Cardiovascular Risk FactorPhase 4DESIFORNCT03889314
The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial
A Phase 4 study testing Rosuvastatin 20mg in people with Cardiovascular Risk Factor and Cardiovascular Diseases, run by Minneapolis Heart Institute Foundation at 1 site in United States.
Trial summary
This study will enroll patients who previously were not able to tolerate being on a statin medication due to muscle-related side effects. Research has shown that many people who have muscle symptoms on statin therapy do not experience the same side effects if they try it again later. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Cardiovascular Diseases, Adverse Effect
- What is being tested?
- Rosuvastatin 20mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2019to 31 Dec 2022
- Phase
- Phase 4
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age 21-75 years old
- Statin eligible according to the 2013 ACC/AHA cholesterol guidelines, including individuals with:
- Known ASCVD
- Diabetes
- LDL-C > 190mg/dl
- 10-year ASCVD risk >7.5%
- Statin intolerant
- Defined by discontinuation of at least 2 separate statins due to potential musculoskeletal side effects
Who cannot join
- Women who are pregnant, nursing or attempting to become pregnant.
- Individuals deemed to be at very high CVD risk and therefore appropriate for a PCSK9 inhibitor including:
- Individuals with familial hypercholesterolemia with markedly elevated LDL-C levels
- Individuals with known ASCVD and recurrent events
- Individuals who are not otherwise clinically indicated to take 20mg rosuvastatin
- Individuals who experienced severe reactions in the past, including:
Show all 9Show fewer
- Rhabdomyolysis
- Severe myositis
- Anaphylaxis
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
About this study
This study will enroll patients who previously were not able to tolerate being on a statin medication due to muscle-related side effects. Research has shown that many people who have muscle symptoms on statin therapy do not experience the same side effects if they try it again later. This study is part of a larger effort to:
- See how common it is for patients to still be intolerant of statin medication after trying it a second time; and
- For those patients who do tolerate being on a statin after trying it a second time, see how common it is for them to still be taking the statin 3 months after completing the main part of the study.
Patients who agree to participate will be given a 5 month randomly allocated supply of statin and placebo and track their symptoms weekly.
Read the detailed description
This study is a single center, double-blinded randomized controlled trial for patients eligible for statin therapy by current guidelines, but not on statin therapy due to a history of statin intolerance. Patients will be provided a "DESIFOR" kit which includes 5 randomly allocated 4-week blister packs of capsules containing either 20mg of rosuvastatin or placebo. While blinded to treatment, patients will document the severity of musculoskeletal symptoms every week using a numerical scale. The primary endpoint will be the difference between the mean musculoskeletal symptom score while randomized to statin therapy compared to the mean score while on placebo. After completion of the study, the results will be unblinded and reviewed at a 6 month follow-up visit with the patient and, for patients with symptoms found to not correlate with statin therapy, a trial of non-blinded statin therapy over the next 3 months will be recommended. This study will serve as a pilot study to determine the feasibility and potential benefits of a larger multicenter trial with similar aims.
- Being tested
- Rosuvastatin 20mg, Placebo
- Keywords
- Statin Therapy, Prevention, High ASCVD Risk
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 20mgDrug
Statin Therapy
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin 20mg | Experimental | Each participant will receive a 3 month randomly allocated supply of this medication preceded by a 7 day wash-out period. Receives: Drug: Rosuvastatin 20mg |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| No Treatment | No intervention | 7 day wash-out period between months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal intolerance (as documented in study assessments)
Prevalence of musculoskeletal intolerance between the groups, defined by a lack of statistical difference in the mean musculoskeletal symptom score while on statin therapy compared to placebo, in patients previously identified as statin intolerant.
Measured: 6 months
Secondary outcomes (1)
Statin Utilization
Number of individuals taking statins 3 months post study
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start26 Apr 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will serve as their own controls in this study whereby they will receive randomly allocated 28-day packets of statin and placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Miedema, MD, Principal investigator, Minneapolis Heart Institute Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889314
- Sponsor's protocol ID
- DESIFOR
- Acronym
- DESIFOR
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2019
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial
- ClinicalTrials.gov ID
- NCT03889314
- Acronym / sponsor ID
- DESIFOR / DESIFOR
- Keywords
- Statin Therapy, Prevention, High ASCVD Risk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Mar 2019 (actual)
- 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.
This study will enroll patients who previously were not able to tolerate being on a statin medication due to muscle-related side effects. Research has shown that many people who have muscle symptoms on statin therapy do not experience the same side effects if they try it again later. This study is part of a larger effort to:
- See how common it is for patients to still be intolerant of statin medication after trying it a second time; and
- For those patients who do tolerate being on a statin after trying it a second time, see how common it is for them to still be taking the statin 3 months after completing the main part of the study.
Patients who agree to participate will be given a 5 month randomly allocated supply of statin and placebo and track their symptoms weekly.
Detailed description
This study is a single center, double-blinded randomized controlled trial for patients eligible for statin therapy by current guidelines, but not on statin therapy due to a history of statin intolerance. Patients will be provided a "DESIFOR" kit which includes 5 randomly allocated 4-week blister packs of capsules containing either 20mg of rosuvastatin or placebo. While blinded to treatment, patients will document the severity of musculoskeletal symptoms every week using a numerical scale. The primary endpoint will be the difference between the mean musculoskeletal symptom score while randomized to statin therapy compared to the mean score while on placebo. After completion of the study, the results will be unblinded and reviewed at a 6 month follow-up visit with the patient and, for patients with symptoms found to not correlate with statin therapy, a trial of non-blinded statin therapy over the next 3 months will be recommended. This study will serve as a pilot study to determine the feasibility and potential benefits of a larger multicenter trial with similar aims.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Patients will serve as their own controls in this study whereby they will receive randomly allocated 28-day packets of statin and placebo.
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin 20mg | Experimental | Drug: Rosuvastatin 20mgEach participant will receive a 3 month randomly allocated supply of this medication preceded by a 7 day wash-out period. |
| Placebo | Placebo comparator | Other: Placebo |
| No Treatment | No intervention | –7 day wash-out period between months |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults age 21-75 years old
- Statin eligible according to the 2013 ACC/AHA cholesterol guidelines, including individuals with:
- Statin intolerant
Key exclusion criteria (9 listed)
- Women who are pregnant, nursing or attempting to become pregnant.
- Individuals deemed to be at very high CVD risk and therefore appropriate for a PCSK9 inhibitor including:
- Individuals who experienced severe reactions in the past, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin 20mgStatin Therapy | Drug | Rosuvastatin 20mg |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Musculoskeletal intolerance (as documented in study assessments)
Time frame: 6 months
Prevalence of musculoskeletal intolerance between the groups, defined by a lack of statistical difference in the mean musculoskeletal symptom score while on statin therapy compared to placebo, in patients previously identified as statin intolerant.
1 secondary outcome
Statin Utilization
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Michael Miedema, MD principal investigator
Minneapolis Heart Institute Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin 20mg in people with Cardiovascular Risk Factor and Cardiovascular Diseases, run by Minneapolis Heart Institute Foundation 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 21 Mar 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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.
What does the primary outcome measure?
Musculoskeletal intolerance (as documented in study assessments) (time frame: 6 months). It is what the study was designed to measure, not a finding.
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 21 Mar 2022.