Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT01431105
Eligibility Criteria:
Inclusion criteria:
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.
Exclusion Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT01431105
Study Brief:
Protocol Section:
NCT01431105