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| Name | Class |
|---|---|
| Children's Hospital Colorado | OTHER |
| University of Colorado, Denver | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvasatin | Experimental | Atorvastatin dose titration to maximum tolerated dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane C Burns, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | San Diego | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27923814 | Derived | He M, Chen Z, Martin M, Zhang J, Sangwung P, Woo B, Tremoulet AH, Shimizu C, Jain MK, Burns JC, Shyy JY. miR-483 Targeting of CTGF Suppresses Endothelial-to-Mesenchymal Transition: Therapeutic Implications in Kawasaki Disease. Circ Res. 2017 Jan 20;120(2):354-365. doi: 10.1161/CIRCRESAHA.116.310233. Epub 2016 Dec 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvasatin | Atorvastatin dose titration to maximum tolerated dose Atorvastatin: Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvasatin | Atorvastatin dose titration to maximum tolerated dose Atorvastatin: Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With SAE | Number of participants who experienced an SAE within the 6 week study period | Posted | Count of Participants | Participants | At 6 weeks after initiation of study drug |
|
|
6 weeks
Clinicaltrials.gov definition used for AEs
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atorvasatin | Atorvastatin dose titration to maximum tolerated dose Atorvastatin: Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recrudescent Fever | Immune system disorders | Systematic Assessment | Fever recurred consistent with recurrence of Kawasaki disease; this SAE was not attributable to the study drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral exanthem | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adriana Tremoulet | UC San Diego | 858-246-0012 | atremoulet@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2016 | May 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009080 | Mucocutaneous Lymph Node Syndrome |
| ID | Term |
|---|---|
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Age | in years | Median | Inter-Quartile Range | years |
|
|
| 0 |
| 34 |
| 4 |
| 34 |
| 24 |
| 34 |
|
| Worsening coronary artery aneurysm | Cardiac disorders | Systematic Assessment | The coronary artery aneurysms worsened due to KD. These SAEs were not attributable to the study drug |
|
| Constipation or Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Bruising | Blood and lymphatic system disorders | Systematic Assessment |
|
| Fever | Immune system disorders | Systematic Assessment |
|
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| D006425 |
| Hemic and Lymphatic Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |