Testing rosuvastatin tolerance in patients with statin intolerance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.