Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of California, San Diego
With
Children's Hospital Colorado
University of Colorado, Denver
Age
2–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Age ≥ 2 years to 17 years old
2. Meets clinical criteria for KD according to American Heart Association guidelines (Table 2): Fever (T≥38oC or 100.4oC) ≥ 3 days and ≥ 2 clinical criteria with left anterior descending coronary artery/right coronary artery z-score ≥ 2.5 or an aneurysm (≥ 1.5 x the adjacent segment) of one of the coronary arteries
3. Patient presents within the first 20 days after fever onset
4. Parent or legal guardian able and willing to provide informed consent and subject willing and able to provide assent when appropriate.
5. Post-menarchal females: Negative pregnancy test at screening and willing to use two forms of contraception during the study
6. Males engaging in sexual activity that could lead to pregnancy must use a condom.
You may not be if
1. Use of a statin, fibrate, or niacin within the 3 months prior to enrollment
2. Have any chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder
3. Screening creatine phosphokinase (CK) ≥ 3x upper limit of normal for age
4. Patient taking a CYP3A4 inhibitor (ie. cyclosporine or clarithromycin) in the last 7 days
5. Patient has a history of allergy to atorvastatin or its derivatives