DESIFOR-EXPAND (MHIF)

NCT ID: NCT06804980

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-12-31

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

Detailed Description

Recently developed lipid lowering therapies have been shown to significantly reduce LDL cholesterol and subsequent CVD risk (1, 2). However, they are expensive, and the cost-effectiveness of these medications remains controversial, especially in primary prevention. Novel lipid lowering therapies are frequently considered for individuals with statin intolerance, but payers frequently deny prescription for these medications due to lack of adequate proof of true statin intolerance. How to accurately determine statin intolerance remains a clinical conundrum for both patients and providers. A more scientific, definitive method to determine statin intolerance could potentially allow appropriate, cost-effective use of statin therapy in individuals found to not actually be statin intolerant as well as judicious use of novel medications in patients who are found to truly be statin intolerant.

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. The DESIFOR pilot study was a single-center, randomized, double-blinded, n-of-1 trial in patients aged 21 to 79 years and eligible for statin therapy by current guidelines but not on therapy due to intolerance of >2 statins. Using a double-blinded, N-of-1 randomized trial in patients with previous statin intolerance, <10% of patients had data suggestive of true statin intolerance, and 2/3 of patients were subsequently able to tolerate 3-months of unblinded treatment with rosuvastatin (3). These data raise the hypothesis that an n-of-1 trial can be used to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance.

Conditions

Statin Therapy; Statin Adverse Reaction; Statin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo taken first, drug taken second

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

Group Type: OTHER

Rosuvastatin (Crestor)

Intervention Type: 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.

Placebo

Intervention Type: 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

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

Group Type: OTHER

Rosuvastatin (Crestor)

Intervention Type: 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.

Placebo

Intervention Type: 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.

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minneapolis Heart Institute Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gretchen Program Director, RDN, CDCES

Role: CONTACT

Gbenson@mhif.org

612-863-3383

Other Identifiers

2236054

Identifier Type: -

Identifier Source: org_study_id