The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial

NCT03889314 | Unknown Phase 4 FDA Drug

• 1 other identifier: DESIFOR
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factor; Cardiovascular Diseases; Adverse Effect

Keywords

Statin Therapy; Prevention; High ASCVD Risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Statin Utilization

  3 months

Study Arms (3)

Rosuvastatin 20mg

EXPERIMENTAL

Each participant will receive a 3 month randomly allocated supply of this medication preceded by a 7 day wash-out period.

Drug: Rosuvastatin 20mg

Placebo

PLACEBO COMPARATOR

Other: Placebo

No Treatment

NO INTERVENTION

7 day wash-out period between months

Interventions

Rosuvastatin 20mg DRUG

Statin Therapy

Rosuvastatin 20mg

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• year ASCVD risk \>7.5%
• Statin intolerant
• Defined by discontinuation of at least 2 separate statins due to potential musculoskeletal side effects

You may not qualify if:

• 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

Sponsors & Collaborators

• Minneapolis Heart Institute Foundation: lead

Study Sites (1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Michael Miedema, MD

  Minneapolis Heart Institute Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will serve as their own controls in this study whereby they will receive randomly allocated 28-day packets of statin and placebo.

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 26, 2019
• Study Start: April 26, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)