The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 20
Summary
- Conditions
- Adverse Effect
- Cardiovascular Diseases
- Cardiovascular Risk Factor
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Patients will serve as their own controls in this study whereby they will receive randomly allocated 28-day packets of statin and placebo.Masking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 21 years and 75 years
- Gender
- Both males and females
Description
This study is a single center, double-blinded randomized controlled trial for patients eligible for statin therapy by current guidelines, but not on statin therapy due to a history of statin intolerance. Patients will be provided a "DESIFOR" kit which includes 5 randomly allocated 4-week blister pac...
This study is a single center, double-blinded randomized controlled trial for patients eligible for statin therapy by current guidelines, but not on statin therapy due to a history of statin intolerance. Patients will be provided a "DESIFOR" kit which includes 5 randomly allocated 4-week blister packs of capsules containing either 20mg of rosuvastatin or placebo. While blinded to treatment, patients will document the severity of musculoskeletal symptoms every week using a numerical scale. The primary endpoint will be the difference between the mean musculoskeletal symptom score while randomized to statin therapy compared to the mean score while on placebo. After completion of the study, the results will be unblinded and reviewed at a 6 month follow-up visit with the patient and, for patients with symptoms found to not correlate with statin therapy, a trial of non-blinded statin therapy over the next 3 months will be recommended. This study will serve as a pilot study to determine the feasibility and potential benefits of a larger multicenter trial with similar aims.
Tracking Information
- NCT #
- NCT03889314
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Michael Miedema, MD Minneapolis Heart Institute Foundation