Testing rosuvastatin tolerance in patients with statin intolerance
The DEterminig Statin Intolerance for Rosuvastatin Trial
This study is testing if people who have had bad reactions to other statins can safely take rosuvastatin to see if it helps manage their cholesterol better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Minneapolis Heart Institute Foundation Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06804980 on ClinicalTrials.gov |
What this trial studies
The DESIFOR pilot study aims to evaluate the feasibility of an n-of-1 trial approach to assess tolerance to rosuvastatin in patients who have previously experienced statin intolerance. This single-center, randomized, double-blinded trial includes adults aged 21 to 79 who have discontinued at least two different statin medications due to side effects. By determining true statin intolerance, the study seeks to facilitate appropriate use of statin therapy and novel lipid-lowering medications, potentially improving patient outcomes and cost-effectiveness. Participants may continue other lipid-lowering therapies while being assessed for rosuvastatin tolerance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 79 with a documented history of intolerance to at least two different statin medications.
Not a fit: Patients who have experienced severe adverse reactions to statins, such as rhabdomyolysis or severe myositis, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable more patients to safely use statins, leading to better management of cholesterol levels and reduced cardiovascular disease risk.
How similar studies have performed: While the approach of using n-of-1 trials is innovative, similar studies have shown promise in assessing medication tolerance, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Gretchen Program Director, RDN, CDCES
- Email: Gbenson@mhif.org
- Phone: 612-863-3383
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.