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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Rosuvastatin (Crestor)
DrugThe 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.
Placebo
DrugThe 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Placebo taken first, drug taken secondOther 2 interventions
Group B: Drug taken first, then placebo taken secondOther 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
9 months2
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.
Time frame
9 months3
Variables associated with statin intolerance
To determine the clinical variables associated with true statin intolerance.
Time frame
9 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov