Actively Recruiting
The DEterminig Statin Intolerance for Rosuvastatin Trial
Led by Minneapolis Heart Institute Foundation · Updated on 2025-02-03
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of an n-of-1 trial to help patients with prior statin intolerance tolerate rosuvastatin, a cholesterol-lowering medication. The trial focuses on individuals aged 21 years and older who are eligible for statin therapy but have stopped using at least two different statins due to side effects. The study aims to better identify true statin intolerance, which could improve treatment decisions and cost-effectiveness of lipid-lowering therapies, especially for those at risk of cardiovascular disease. Participants will be randomly assigned to receive either placebo or rosuvastatin first, followed by the other treatment, in a double-blinded manner. They will take three 28-day packs of placebo and two 28-day packs of rosuvastatin during the study period. This design helps determine whether patients can tolerate rosuvastatin when unblinded after the initial blinded phase. During the 9-month study, researchers will monitor the presence or absence of musculoskeletal symptoms, statin tolerance, and factors associated with statin intolerance. Participants may continue their other lipid-lowering treatments if stable for at least one month. The study involves regular assessments to track symptoms and response, with safety and tolerance carefully evaluated throughout the trial.
CONDITIONS
Brief Title
DESIFOR-EXPAND (MHIF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 21 years or older with a prior history of statin intolerance defined by stopping at least two different statins due to side effects
- Patients may be on other lipid-lowering therapies like ezetimibe or PCSK9 inhibitors if tolerated for at least 1 month
- At least 30 days since last discontinuing a statin
- Eligible for statin therapy by current guidelines but not currently on statins due to intolerance
You will not qualify if you...
- Women who are pregnant, nursing, or trying to become pregnant
- Individuals with a history of severe reactions to statins such as rhabdomyolysis, severe myositis, or anaphylaxis
- Individuals not clinically indicated to take rosuvastatin 20 mg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 5 months
Participants take 3 packs of placebo and 2 packs of rosuvastatin in a randomized order, each pack lasting 28 days.
5 treatment periods of 28 days each
Trial Site Locations
Total: 1 location
1
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
Research Team
G
Gretchen Program Director, RDN, CDCES
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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