Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities

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Brief Title

Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities

Official Title

Phase I/IIa Study of Pharmacokinetics and Safety of Atorvastatin in Children With Coronary Artery Abnormalities Secondary to 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.

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Number of Participants With SAE

Condition

Kawasaki Disease

Intervention

Atorvastatin

Study Arms / Comparison Groups

 Atorvasatin
Description:  Atorvastatin dose titration to maximum tolerated dose

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

34

Start Date

July 2012

Completion Date

July 2018

Primary Completion Date

January 2018

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

Gender

All

Ages

2 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Jane C Burns, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01431105

Organization ID

KD-Atorvastatin

Responsible Party

Principal Investigator

Study Sponsor

University of California, San Diego

Collaborators

 Children's Hospital Colorado

Study Sponsor

Jane C Burns, MD, Principal Investigator, University of California, San Diego

Verification Date

May 2020