Clinical trial NCT03889314: The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial
Official title: The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiovascular Risk Factor
Cardiovascular Diseases
Adverse Effect
Keywords: Statin Therapy
Prevention
High ASCVD Risk
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will serve as their own controls in this study whereby they will receive randomly allocated 28-day packets of statin and placebo.
Primary purpose: PREVENTION

Brief summary: This study will enroll patients who previously were not able to tolerate being on a statin medication due to muscle-related side effects. Research has shown that many people who have muscle symptoms on statin therapy do not experience the same side effects if they try it again later. This study is part of a larger effort to:

* See how common it is for patients to still be intolerant of statin medication after trying it a second time; and
* For those patients who do tolerate being on a statin after trying it a second time, see how common it is for them to still be taking the statin 3 months after completing the main part of the study.

Patients who agree to participate will be given a 5 month randomly allocated supply of statin and placebo and track their symptoms weekly.

Detailed description: This study is a single center, double-blinded randomized controlled trial for patients eligible for statin therapy by current guidelines, but not on statin therapy due to a history of statin intolerance. Patients will be provided a "DESIFOR" kit which includes 5 randomly allocated 4-week blister packs of capsules containing either 20mg of rosuvastatin or placebo. While blinded to treatment, patients will document the severity of musculoskeletal symptoms every week using a numerical scale. The primary endpoint will be the difference between the mean musculoskeletal symptom score while randomized to statin therapy compared to the mean score while on placebo. After completion of the study, the results will be unblinded and reviewed at a 6 month follow-up visit with the patient and, for patients with symptoms found to not correlate with statin therapy, a trial of non-blinded statin therapy over the next 3 months will be recommended. This study will serve as a pilot study to determine the feasibility and potential benefits of a larger multicenter trial with similar aims.

Eligibility criteria: Inclusion Criteria:

* Adults age 21-75 years old
* Statin eligible according to the 2013 ACC/AHA cholesterol guidelines, including individuals with:

  * Known ASCVD
  * Diabetes
  * LDL-C \> 190mg/dl
  * 10-year ASCVD risk \>7.5%
* Statin intolerant

  * Defined by discontinuation of at least 2 separate statins due to potential musculoskeletal side effects

Exclusion Criteria:

* Women who are pregnant, nursing or attempting to become pregnant.
* Individuals deemed to be at very high CVD risk and therefore appropriate for a PCSK9 inhibitor including:

  * Individuals with familial hypercholesterolemia with markedly elevated LDL-C levels
  * Individuals with known ASCVD and recurrent events
  * Individuals who are not otherwise clinically indicated to take 20mg rosuvastatin
* Individuals who experienced severe reactions in the past, including:

  * Rhabdomyolysis
  * Severe myositis
  * Anaphylaxis

Primary outcomes:
measure: Musculoskeletal intolerance (as documented in study assessments)
timeFrame: 6 months
Secondary outcomes:
measure: Statin Utilization
timeFrame: 3 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
Study officials:
affiliation: Minneapolis Heart Institute Foundation
name: Michael Miedema, MD
role: PRINCIPAL_INVESTIGATOR
References: