DESIFOR-EXPAND (MHIF)
The DEterminig Statin Intolerance for Rosuvastatin Trial
Minneapolis Heart Institute Foundation
100 participants
Feb 1, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria2
- 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.
- \. At least 30 days since discontinued use of a statin
Exclusion Criteria3
- 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
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Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06804980