Kawasaki Disease
Conditions
Keywords
Kawasaki disease
Brief summary
Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that could lead to complications later in life, including heart attack. Although investigators can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Inflammation and damage to the arterial wall is central to these coronary artery abnormalities. Statins, a class of drugs that is known for lowering cholesterol, have also been shown to decrease inflammation in general as well as at the level of the vessel wall. Therefore, the investigators propose to study the safety of the drug atorvastatin in children with coronary artery abnormalities from KD.
Interventions
DRUGAtorvastatin
Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks)
Sponsors
Children's Hospital Colorado
University of Colorado, Denver
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With SAE | At 6 weeks after initiation of study drug | Number of participants who experienced an SAE within the 6 week study period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atorvasatin Atorvastatin dose titration to maximum tolerated dose
Atorvastatin: Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks) | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Atorvasatin |
|---|---|
| Age | 4 years |
| Age, Categorical <=18 years | 34 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 34 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 24 / 34 |
| serious Total, serious adverse events | 4 / 34 |
Outcome results
Primary
Number of Participants With SAE
Number of participants who experienced an SAE within the 6 week study period
Time frame: At 6 weeks after initiation of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atorvasatin | Number of Participants With SAE | 4 Participants |