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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01431105
Other study ID # KD-Atorvastatin
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date July 2012
Est. completion date July 2018

Study information

Verified date May 2020
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date July 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 2 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Atorvastatin
Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks)

Locations

Country Name City State
United States University of California San Diego San Diego California

Sponsors (3)

Lead Sponsor Collaborator
University of California, San Diego Children's Hospital Colorado, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With SAE Number of participants who experienced an SAE within the 6 week study period At 6 weeks after initiation of study drug
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