The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial (DESIFOR)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Cardiovascular Risk Factor; Adverse Effect
• Intervention / Treatment: Other: Placebo; Drug: Rosuvastatin 20mg

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Other: Placebo; Placebo
EXPERIMENTAL: Rosuvastatin 20mg; Each participant will receive a 3 month randomly allocated supply of this medication preceded by a 7 day wash-out period.	Drug: Rosuvastatin 20mg; Statin Therapy
NO_INTERVENTION: No Treatment; 7 day wash-out period between months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Musculoskeletal intolerance (as documented in study assessments)	Prevalence of musculoskeletal intolerance between the groups, defined by a lack of statistical difference in the mean musculoskeletal symptom score while on statin therapy compared to placebo, in patients previously identified as statin intolerant.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Statin Utilization	Number of individuals taking statins 3 months post study	3 months

Collaborators and Investigators

• Sponsor: Minneapolis Heart Institute Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2019
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (ACTUAL): March 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Prevention; Statin Therapy; High ASCVD Risk
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: DESIFOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No