| NCT ID | NCT06804980 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Minneapolis Heart Institute Foundation |
| Condition | Statin Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2025-02-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06804980 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Statin Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06804980 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06804980 currently recruiting?
Yes, NCT06804980 is actively recruiting participants. Contact the research team at Gbenson@mhif.org for enrollment information.
Where is the NCT06804980 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06804980 clinical trial?
NCT06804980 is sponsored by Minneapolis Heart Institute Foundation. The trial plans to enroll 100 participants.