Recruiting

DESIFOR-EXPAND

Sponsor:

Minneapolis Heart Institute Foundation

Code:

NCT06804980

Conditions

Statin Therapy

Statin Adverse Reaction

Statin

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Rosuvastatin (Crestor)

Placebo

Study Details

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

Study ID

NCT06804980

Start date

Feb 1, 2025

Status verified date

Jan, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • 2. At least 30 days since discontinued use of a statin

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Placebo taken first, drug taken second

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

other: Drug taken first, then placebo taken second

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

Interventions

Rosuvastatin (Crestor)

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.

Placebo

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.

Primary outcome measure

  • Musculoskeletal symptom presence/absence [ Time Frame: 9 months ]
  • Statin Tolerance [ Time Frame: 9 months ]
  • Variables associated with statin intolerance [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Gretchen Program Director, RDN, CDCES

612-863-3383Gbenson@mhif.org

Locations

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

More Information

Sponsor

Minneapolis Heart Institute Foundation

Last update posted

Feb 3, 2025

Last verified

Jan, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Minneapolis Heart Institute Foundation on 2025-02-03.