DESIFOR-EXPAND (MHIF)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21+
SponsorMinneapolis Heart Institute Foundation
About this 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
Eligibility criteria
Qualifiers
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
Disqualifiers
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 design
Treatments tested in this trial
- Rosuvastatin (Crestor)
- Placebo
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov