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DESIFOR-EXPAND Study for Statin Intolerance

This study, called DESIFOR-EXPAND, is looking for adults who have had trouble taking statin medications (like rosuvastatin, also known as Crestor) in the past due to side effects. The study aims to find a better way to determine if someone is truly statin intolerant. You would receive both rosuvastatin and a placebo (an inactive pill) at different times, with the order decided by chance. Researchers will measure your muscle symptoms and how well you tolerate statins over 9 months to see if this approach helps understand statin intolerance better. The study is currently unclear on its recruitment status and plans to enroll 100 participants.

Study design
This is an interventional study where participants will be randomly assigned the order in which they take rosuvastatin and placebo. It is designed as an n-of-1 trial, meaning each participant serves as their own control.
What's involved
You will take 3 packs of placebo and 2 packs of rosuvastatin, each lasting 28 days. The specific order will be assigned randomly.
Compensation
Not stated in the trial record.
Follow-up
Your musculoskeletal symptoms, statin tolerance, and related variables will be measured at 9 months.

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NCT06804980

DESIFOR-EXPAND (MHIF)

Recruiting
PHASE4Ages 21+InterventionalTreatment
Minneapolis Heart Institute Foundation
~100 participants
Updated 2025-02-03 on ClinicalTrials.gov
What's tested:Rosuvastatin (Crestor)Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Musculoskeletal symptom presence/absence
Measured over 9 months
+2 more outcomes measured

Conditions

Statin Therapy
Statin Adverse Reaction
Statin

Explore related trials

Statin Intolerance

Where it's being run

1 sites across 1 states
Minnesota1

Who to contact

Gretchen Program Director, RDN, CDCES
[email protected]
612-863-3383
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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Musculoskeletal symptom presence/absence9 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 Tolerance9 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 intolerance9 months

    To determine the clinical variables associated with true statin intolerance.