RECRUITING

DESIFOR-EXPAND (MHIF)

Conditions

Statin Therapy Statin Adverse Reaction Statin Statin Intolerance lipid-lowering medication LDL LDL Cholesterol

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

The DEterminig Statin Intolerance for Rosuvastatin Trial

Quick Facts

Study Start:2025-02-01

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06804980

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Gretchen Program Director, RDN, CDCES

CONTACT

612-863-3383

Gbenson@mhif.org

Study Locations (Sites)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407

United States

Collaborators and Investigators

Sponsor: Minneapolis Heart Institute Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-01

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-02-01

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Statin Intolerance
lipid-lowering medication
LDL
LDL Cholesterol

Additional Relevant MeSH Terms

Statin Therapy
Statin Adverse Reaction
Statin