The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Minneapolis Heart Institute Foundation
• Treatments: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Adults age 21-75 years old

• Statin eligible according to the 2013 ACC/AHA cholesterol guidelines, including individuals with:

• Known ASCVD

• Diabetes

• LDL-C > 190mg/dl

• 10-year ASCVD risk >7.5%

• Statin intolerant

• Defined by discontinuation of at least 2 separate statins due to potential musculoskeletal side effects

Exclusion Criteria:

• Women who are pregnant, nursing or attempting to become pregnant.

• Individuals deemed to be at very high CVD risk and therefore appropriate for a PCSK9 inhibitor including:

• Individuals with familial hypercholesterolemia with markedly elevated LDL-C levels

• Individuals with known ASCVD and recurrent events

• Individuals who are not otherwise clinically indicated to take 20mg rosuvastatin

• Individuals who experienced severe reactions in the past, including:

• Rhabdomyolysis

• Severe myositis

• Anaphylaxis