DESIFOR-EXPAND (MHIF)

NCT06804980 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2236054
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The DESIFOR pilot study was conducted to determine the feasibility of utilizing an n-of-1 trial to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance

Conditions

Statin Therapy; Statin Adverse Reaction; Statin

Keywords

Statin Intolerance; lipid-lowering medication; LDL; LDL Cholesterol

Outcome Measures

Primary Outcomes (3)

• Musculoskeletal symptom presence/absence

  To determine the prevalence of true statin intolerance, defined by a statistical difference in the mean musculoskeletal symptom score while on statin therapy compared to placebo, in patients previously identified as statin intolerant.

  9 months

• Statin Tolerance

  To determine the prevalence of statin tolerance, defined as continuous use of 3 months of unblinded rosuvastatin, in individuals with previous statin intolerance but without evidence of true statin intolerance in the DESIFOR protocol.

  9 months

• Variables associated with statin intolerance

  To determine the clinical variables associated with true statin intolerance.

  9 months

Study Arms (2)

Placebo taken first, drug taken second

OTHER

The placebo is assigned to the patient first, with the medication taken in the second part of participation.

Drug: Rosuvastatin (Crestor); Drug: Placebo

Drug taken first, then placebo taken second

OTHER

The placebo is assigned to the patient first, with the medication taken in the second part of participation.

Drug: Rosuvastatin (Crestor); Drug: Placebo

Interventions

Rosuvastatin (Crestor) DRUG

The patient will take 3 28-day packs of placebo and 2 28-day packs of rosuvastatin. The order in which they take the placebo or rosuvastatin will be assigned at random.

Drug taken first, then placebo taken second; Placebo taken first, drug taken second

Placebo DRUG

The patient will take 3 28-day packs of placebo and 2 28-day packs of rosuvastatin. The order in which they take the placebo or rosuvastatin will be assigned at random.

Drug taken first, then placebo taken second; Placebo taken first, drug taken second

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥ 21 years old) with a prior history of statin intolerance. Statin intolerance is defined by discontinuation of at least 2 different statin medications due to possible side effects. Patients can participate in the trial while on other lipid-lowering agents, such as ezetimibe and PSCK9 inhibitors, as long as the patient has been on the other lipid lowering therapy and tolerating it well for at least 1 month. For individuals with established ASCVD or multiple ASCVD risk factors, initiation of other lipid lowering therapy prior to participation in DESIFOR is encouraged.
• \. At least 30 days since discontinued use of a statin

You may not qualify if:

• Women who are pregnant, nursing or attempting to become pregnant
• Individuals who experienced severe reactions in the past, including rhabdomyolysis, severe myositis, anaphylaxis
• Individuals who are not otherwise clinically indicated to take rosuvastatin 20 mg

Sponsors & Collaborators

• Minneapolis Heart Institute Foundation: lead

Study Sites (1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

MeSH Terms

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

Central Study Contacts

Gretchen Program Director, RDN, CDCES

CONTACT

612-863-3383; Gbenson@mhif.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: There will be unblinded and blinded research staff. Unblinding for the patient and provider will occur at 6-month follow-up.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each kit will include 3 28-day packs of placebo and 2 28-day packs of rosuvastatin, assigned at random. Each kit will have a unique identification number, which the pharmacy will record in a drug tracking log as it is dispensed. Within each kit, a unique identifying number will be present on each blister pack which can be used to determine the order of allocation of placebo and rosuvastatin.

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 3, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)