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The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial

NCT03889314 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-03-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Rosuvastatin 20mg

Statin Therapy

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Minneapolis Heart Institute Foundation

    lead OTHER

Principal Investigators

  • Michael Miedema, MD · Minneapolis Heart Institute Foundation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-26
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03889314 on ClinicalTrials.gov