NCT03889314

The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Minneapolis Heart Institute Foundation · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study will enroll patients who previously were not able to tolerate being on a statin medication due to muscle-related side effects. Research has shown that many people who have muscle symptoms on statin therapy do not experience the same side effects if they try it again later. This study is part of a larger effort to: * See how common it is for patients to still be intolerant of statin medication after trying it a second time; and * For those patients who do tolerate being on a statin after trying it a second time, see how common it is for them to still be taking the statin 3 months after completing the main part of the study. Patients who agree to participate will be given a 5 month randomly allocated supply of statin and placebo and track their symptoms weekly.

Detailed 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 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.

Conditions

• Cardiovascular Risk Factor
• Cardiovascular Diseases
• Adverse Effect

Interventions

Type	Name	Description
DRUG	Rosuvastatin 20mg	Statin Therapy
OTHER	Placebo	Placebo

Timeline

• Start date: 2019-04-26
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2019-03-26
• Last updated: 2022-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study