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The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial

Sponsor
Minneapolis Heart Institute Foundation (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03889314
Collaborator
(none)
25
Enrollment
1
Location
3
Arms
44.2
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Rosuvastatin 20mg
  • Other: Placebo
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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
Official Title:
The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial
Actual Study Start Date :
Apr 26, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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
Placebo Comparator: Placebo

Other: Placebo
Placebo
No Intervention: No Treatment

7 day wash-out period between months

Outcome Measures

Primary Outcome Measures

  1. Musculoskeletal intolerance (as documented in study assessments) [6 months]

    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.

Secondary Outcome Measures

  1. Statin Utilization [3 months]

    Number of individuals taking statins 3 months post study

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Minneapolis Heart Institute Foundation Minneapolis Minnesota United States 55407

Sponsors and Collaborators

  • Minneapolis Heart Institute Foundation

Investigators

  • Principal Investigator: Michael Miedema, MD, Minneapolis Heart Institute Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier:
NCT03889314
Other Study ID Numbers:
  • DESIFOR
First Posted:
Mar 26, 2019
Last Update Posted:
Mar 21, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Minneapolis Heart Institute Foundation
Statin Therapy
Prevention
High ASCVD Risk
Additional relevant MeSH terms:
Cardiovascular Diseases
Rosuvastatin Calcium

Study Results

No Results Posted as of Mar 21, 2022