Statin TherapyPhase 4NCT06804980
DESIFOR-EXPAND (MHIF)
A Phase 4 study testing Rosuvastatin (Crestor) in people with Statin Therapy and Statin Adverse Reaction, run by Minneapolis Heart Institute Foundation at 1 site in United States.
Trial summary
The DESIFOR pilot study was conducted to determine the feasibility of utilizing an n-of-1 trial to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Statin Therapy, Statin Adverse Reaction, Statin
- What is being tested?
- Rosuvastatin (Crestor)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥ 21 years old) with a prior history of statin intolerance. Statin intolerance is defined by discontinuation of at least 2 different statin medications due to possible side effects. Patients can participate in the trial while on other lipid-lowering agents, such as ezetimibe and PSCK9 inhibitors, as long as the patient has been on the other lipid lowering therapy and tolerating it well for at least 1 month. For individuals with established ASCVD or multiple ASCVD risk factors, initiation of other lipid lowering therapy prior to participation in DESIFOR is encouraged.
- 2. At least 30 days since discontinued use of a statin
Who cannot join
- Women who are pregnant, nursing or attempting to become pregnant
- Individuals who experienced severe reactions in the past, including rhabdomyolysis, severe myositis, anaphylaxis
- Individuals who are not otherwise clinically indicated to take rosuvastatin 20 mg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
About this study
Official title: The DEterminig Statin Intolerance for Rosuvastatin Trial
The DESIFOR pilot study was conducted to determine the feasibility of utilizing an n-of-1 trial to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance
Read the detailed description
Recently developed lipid lowering therapies have been shown to significantly reduce LDL cholesterol and subsequent CVD risk (1, 2). However, they are expensive, and the cost-effectiveness of these medications remains controversial, especially in primary prevention. Novel lipid lowering therapies are frequently considered for individuals with statin intolerance, but payers frequently deny prescription for these medications due to lack of adequate proof of true statin intolerance. How to accurately determine statin intolerance remains a clinical conundrum for both patients and providers. A more scientific, definitive method to determine statin intolerance could potentially allow appropriate, cost-effective use of statin therapy in individuals found to not actually be statin intolerant as well as judicious use of novel medications in patients who are found to truly be statin intolerant.
The DESIFOR pilot study was conducted to determine the feasibility of utilizing an n-of-1 trial to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance. The DESIFOR pilot study was a single-center, randomized, double-blinded, n-of-1 trial in patients aged 21 to 79 years and eligible for statin therapy by current guidelines but not on therapy due to intolerance of >2 statins. Using a double-blinded, N-of-1 randomized trial in patients with previous statin intolerance, <10% of patients had data suggestive of true statin intolerance, and 2/3 of patients were subsequently able to tolerate 3-months of unblinded treatment with rosuvastatin (3). These data raise the hypothesis that an n-of-1 trial can be used to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance.
- Conditions
- Statin Therapy, Statin Adverse Reaction, Statin
- Being tested
- Rosuvastatin (Crestor), Placebo
- Keywords
- Statin Intolerance, lipid-lowering medication, LDL, LDL Cholesterol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin (Crestor)Drug
The patient will take 3 28-day packs of placebo and 2 28-day packs of rosuvastatin. The order in which they take the placebo or rosuvastatin will be assigned at random.
PlaceboDrug
The patient will take 3 28-day packs of placebo and 2 28-day packs of rosuvastatin. The order in which they take the placebo or rosuvastatin will be assigned at random.
| Study group | Role | What they receive |
|---|---|---|
| Placebo taken first, drug taken second | Other | The placebo is assigned to the patient first, with the medication taken in the second part of participation. Receives: Drug: Rosuvastatin (Crestor); Drug: Placebo |
| Drug taken first, then placebo taken second | Other | The placebo is assigned to the patient first, with the medication taken in the second part of participation. Receives: Drug: Rosuvastatin (Crestor); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal symptom presence/absence
To determine the prevalence of true statin intolerance, defined by a statistical difference in the mean musculoskeletal symptom score while on statin therapy compared to placebo, in patients previously identified as statin intolerant.
Measured: 9 months
Statin Tolerance
To determine the prevalence of statin tolerance, defined as continuous use of 3 months of unblinded rosuvastatin, in individuals with previous statin intolerance but without evidence of true statin intolerance in the DESIFOR protocol.
Measured: 9 months
Variables associated with statin intolerance
To determine the clinical variables associated with true statin intolerance.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Feb 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Statin TherapyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Each kit will include 3 28-day packs of placebo and 2 28-day packs of rosuvastatin, assigned at random. Each kit will have a unique identification number, which the pharmacy will record in a drug tracking log as it is dispensed. Within each kit, a unique identifying number will be present on each blister pack which can be used to determine the order of allocation of placebo and rosuvastatin.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804980
- Sponsor's protocol ID
- 2236054
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 3 Feb 2025
- 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 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DEterminig Statin Intolerance for Rosuvastatin Trial
- ClinicalTrials.gov ID
- NCT06804980
- Acronym / sponsor ID
- 2236054
- Conditions
- Statin Therapy, Statin Adverse Reaction, Statin
- Keywords
- Statin Intolerance, lipid-lowering medication, LDL, LDL Cholesterol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Feb 2025 (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.
The DESIFOR pilot study was conducted to determine the feasibility of utilizing an n-of-1 trial to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance
Detailed description
Recently developed lipid lowering therapies have been shown to significantly reduce LDL cholesterol and subsequent CVD risk (1, 2). However, they are expensive, and the cost-effectiveness of these medications remains controversial, especially in primary prevention. Novel lipid lowering therapies are frequently considered for individuals with statin intolerance, but payers frequently deny prescription for these medications due to lack of adequate proof of true statin intolerance. How to accurately determine statin intolerance remains a clinical conundrum for both patients and providers. A more scientific, definitive method to determine statin intolerance could potentially allow appropriate, cost-effective use of statin therapy in individuals found to not actually be statin intolerant as well as judicious use of novel medications in patients who are found to truly be statin intolerant.
The DESIFOR pilot study was conducted to determine the feasibility of utilizing an n-of-1 trial to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance. The DESIFOR pilot study was a single-center, randomized, double-blinded, n-of-1 trial in patients aged 21 to 79 years and eligible for statin therapy by current guidelines but not on therapy due to intolerance of >2 statins. Using a double-blinded, N-of-1 randomized trial in patients with previous statin intolerance, <10% of patients had data suggestive of true statin intolerance, and 2/3 of patients were subsequently able to tolerate 3-months of unblinded treatment with rosuvastatin (3). These data raise the hypothesis that an n-of-1 trial can be used to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Each kit will include 3 28-day packs of placebo and 2 28-day packs of rosuvastatin, assigned at random. Each kit will have a unique identification number, which the pharmacy will record in a drug tracking log as it is dispensed. Within each kit, a unique identifying number will be present on each blister pack which can be used to determine the order of allocation of placebo and rosuvastatin.
| Arm | Type | Receives |
|---|---|---|
| Placebo taken first, drug taken second | Other | Drug: Rosuvastatin (Crestor), Drug: PlaceboThe placebo is assigned to the patient first, with the medication taken in the second part of participation. |
| Drug taken first, then placebo taken second | Other | Drug: Rosuvastatin (Crestor), Drug: PlaceboThe placebo is assigned to the patient first, with the medication taken in the second part of participation. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (≥ 21 years old) with a prior history of statin intolerance. Statin intolerance is defined by discontinuation of at least 2 different statin medications due to possible side effects. Patients can participate in the trial while on other lipid-lowering agents, such as ezetimibe and PSCK9 inhibitors, as long as the patient has been on the other lipid lowering therapy and tolerating it well for at least 1 month. For individuals with established ASCVD or multiple ASCVD risk factors, initiation of other lipid lowering therapy prior to participation in DESIFOR is encouraged.
- 2. At least 30 days since discontinued use of a statin
Key exclusion criteria (3 listed)
- Women who are pregnant, nursing or attempting to become pregnant
- Individuals who experienced severe reactions in the past, including rhabdomyolysis, severe myositis, anaphylaxis
- Individuals who are not otherwise clinically indicated to take rosuvastatin 20 mg
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 (Crestor)The patient will take 3 28-day packs of placebo and 2 28-day packs of rosuvastatin. The order in which they take the placebo or rosuvastatin will be assigned at random. | Drug | Drug taken first, then placebo taken second, Placebo taken first, drug taken second |
| PlaceboThe patient will take 3 28-day packs of placebo and 2 28-day packs of rosuvastatin. The order in which they take the placebo or rosuvastatin will be assigned at random. | Drug | Drug taken first, then placebo taken second, Placebo taken first, drug taken second |
Primary outcome
Musculoskeletal symptom presence/absence
Time frame: 9 months
To determine the prevalence of true statin intolerance, defined by a statistical difference in the mean musculoskeletal symptom score while on statin therapy compared to placebo, in patients previously identified as statin intolerant.
Statin Tolerance
Time frame: 9 months
To determine the prevalence of statin tolerance, defined as continuous use of 3 months of unblinded rosuvastatin, in individuals with previous statin intolerance but without evidence of true statin intolerance in the DESIFOR protocol.
Variables associated with statin intolerance
Time frame: 9 months
To determine the clinical variables associated with true statin intolerance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- 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.
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 (Crestor) in people with Statin Therapy and Statin Adverse Reaction, 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 3 Feb 2025. 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gretchen Program Director, RDN, CDCES (612-863-3383, Gbenson@mhif.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musculoskeletal symptom presence/absence (time frame: 9 months). The study lists 3 primary outcomes in all. 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 3 Feb 2025.