Kawasaki DiseasePhase 2NCT00305201
Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease
A Phase 2 study testing pravastatin in people with Kawasaki Disease, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The purpose of this study is to determine whether Chilean children with history of Kawasaki disease have endothelial dysfunction years after the acute phase of the disease, and if this condition can be modified by treatment with statins. Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Kawasaki Disease
- What is being tested?
- pravastatin
- How many people
- 0 participants
- Where
- 1 siteChile
- Study dates
- Apr 2006to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- History of Kawasaki disease more than 12 months before enrollment
- Present age of 8 years or older
Who cannot join
- Diabetes mellitus
- Not controlled hypertension
- Treatment with drugs thay modify endothelial function such as angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, and calcium channel blockers
- Smokers of more than 5 cigarettes per day
- Total cholesterol higher than 250 mg/dl
- Triglycerides higher than 300mg/dl
- Chronic treatment with statins
- Chronic renal insufficiency (creatinine > 1.5 mg/dl)
Trial locations and contacts
1 site in 1 country.
Chile1 site
Pontificia Universidad Catolica de Chile, School of Medicine
Santiago, Santiago Metropolitan
About this study
Official title: Cardiovascular Risk Markers Before and After Therapy With Statins in Patients With History of Kawasaki Disease
The purpose of this study is to determine whether Chilean children with history of Kawasaki disease have endothelial dysfunction years after the acute phase of the disease, and if this condition can be modified by treatment with statins.
Read the detailed description
Kawasaki disease (KD) in its acute phase produces endothelial inflammation that can lead to dilatation and aneurysms of coronary and peripheral arteries. This initial injury leads to persistent endothelial dysfunction several years after having the disease. As a consequence, these patients may have a higher cardiovascular risk than general population. Studies with HMG-CoA reductase inhibitors (statins) have suggested that these have an anti-inflammatory effect over the endothelium, that may be independent of its lipid-lowering effects. The hypothesis of this study is that KD produces endothelial dysfunction that is persistent years after acute disease, and that this dysfunction can be modified by treatment with statins.The study consists of two phases. On the first we will perform ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery and evaluate other cardiovascular risk markers in patients and healthy controls. On the second phase patients with history of Kawasaki disease will be randomized and allocated to treatment with Pravastatin or placebo, after which a new evaluation of flow-mediated dilation of the brachial artery and cardiovascular risk markers will be performed.
Comparison(s): Children older than 8 years of age with history of Kawasaki disease more than 12 months before enrollment, compared with paired by age children without history of KD or other cardiovascular risk factors.
- Conditions
- Kawasaki Disease
- Being tested
- pravastatin
- Keywords
- Mucocutaneous Lymph Node Syndrome, Kawasaki disease, Endothelial dysfunction, Pravastatin, Statin therapy
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pravastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of change in brachial artery dilatation after statin therapy
Secondary outcomes (4)
Decrease in LDL
Increase in HDL
Decrease in triglycerides
Decrease in high sensitivity CRP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2006 (estimated)
- Study startApr 2006
- Study completionMay 2007 (estimated)
Why it stopped: Withdrawn due to lack of study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Arturo Borzutzky, MD, Principal investigator, Pontificia Universidad Catolica de Chile, School of Medicine, Department of PediatricsMiguel Gutierrez, MD, Study director, Pontificia Universidad Catolica de Chile, School of Medicine, Department of Rheumatology and Clinical Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305201
- Sponsor's protocol ID
- PG-29/05
- Status last verified
- May 2016
- First submitted
- 20 Mar 2006
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kato H, Sugimura T, Akagi T, Sato N, Hashino K, Maeno Y, Kazue T, Eto G, Yamakawa R. Long-term consequences of Kawasaki disease. A 10- to 21-year follow-up study of 594 patients. Circulation. 1996 Sep 15;94(6):1379-85. doi: 10.1161/01.cir.94.6.1379.
PubMed 8822996Dhillon R, Clarkson P, Donald AE, Powe AJ, Nash M, Novelli V, Dillon MJ, Deanfield JE. Endothelial dysfunction late after Kawasaki disease. Circulation. 1996 Nov 1;94(9):2103-6. doi: 10.1161/01.cir.94.9.2103.
PubMed 8901658Furuyama H, Odagawa Y, Katoh C, Iwado Y, Ito Y, Noriyasu K, Mabuchi M, Yoshinaga K, Kuge Y, Kobayashi K, Tamaki N. Altered myocardial flow reserve and endothelial function late after Kawasaki disease. J Pediatr. 2003 Feb;142(2):149-54. doi: 10.1067/mpd.2003.46.
PubMed 12584536de Jongh S, Lilien MR, op't Roodt J, Stroes ES, Bakker HD, Kastelein JJ. Early statin therapy restores endothelial function in children with familial hypercholesterolemia. J Am Coll Cardiol. 2002 Dec 18;40(12):2117-21. doi: 10.1016/s0735-1097(02)02593-7.
PubMed 12505222
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Markers Before and After Therapy With Statins in Patients With History of Kawasaki Disease
- ClinicalTrials.gov ID
- NCT00305201
- Acronym / sponsor ID
- PG-29/05
- Conditions
- Kawasaki Disease
- Keywords
- Mucocutaneous Lymph Node Syndrome, Kawasaki disease, Endothelial dysfunction, Pravastatin, Statin therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to lack of study participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Apr 2006
- Study completion
- May 2007 (estimated)
- First posted
- 21 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Chilean children with history of Kawasaki disease have endothelial dysfunction years after the acute phase of the disease, and if this condition can be modified by treatment with statins.
Detailed description
Kawasaki disease (KD) in its acute phase produces endothelial inflammation that can lead to dilatation and aneurysms of coronary and peripheral arteries. This initial injury leads to persistent endothelial dysfunction several years after having the disease. As a consequence, these patients may have a higher cardiovascular risk than general population. Studies with HMG-CoA reductase inhibitors (statins) have suggested that these have an anti-inflammatory effect over the endothelium, that may be independent of its lipid-lowering effects. The hypothesis of this study is that KD produces endothelial dysfunction that is persistent years after acute disease, and that this dysfunction can be modified by treatment with statins.The study consists of two phases. On the first we will perform ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery and evaluate other cardiovascular risk markers in patients and healthy controls. On the second phase patients with history of Kawasaki disease will be randomized and allocated to treatment with Pravastatin or placebo, after which a new evaluation of flow-mediated dilation of the brachial artery and cardiovascular risk markers will be performed.
Comparison(s): Children older than 8 years of age with history of Kawasaki disease more than 12 months before enrollment, compared with paired by age children without history of KD or other cardiovascular risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- History of Kawasaki disease more than 12 months before enrollment
- Present age of 8 years or older
Key exclusion criteria (8 listed)
- Diabetes mellitus
- Not controlled hypertension
- Treatment with drugs thay modify endothelial function such as angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, and calcium channel blockers
- Smokers of more than 5 cigarettes per day
- Total cholesterol higher than 250 mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pravastatin | Drug | – |
Primary outcome
Percent of change in brachial artery dilatation after statin therapy
4 secondary outcomes
Decrease in LDL
Increase in HDL
Decrease in triglycerides
Decrease in high sensitivity CRP
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Background: PubMed 8822996Kato H, Sugimura T, Akagi T, Sato N, Hashino K, Maeno Y, Kazue T, Eto G, Yamakawa R. Long-term consequences of Kawasaki disease. A 10- to 21-year follow-up study of 594 patients. Circulation. 1996 Sep 15;94(6):1379-85. doi: 10.1161/01.cir.94.6.1379.
- Background: PubMed 8901658Dhillon R, Clarkson P, Donald AE, Powe AJ, Nash M, Novelli V, Dillon MJ, Deanfield JE. Endothelial dysfunction late after Kawasaki disease. Circulation. 1996 Nov 1;94(9):2103-6. doi: 10.1161/01.cir.94.9.2103.
- Background: PubMed 12584536Furuyama H, Odagawa Y, Katoh C, Iwado Y, Ito Y, Noriyasu K, Mabuchi M, Yoshinaga K, Kuge Y, Kobayashi K, Tamaki N. Altered myocardial flow reserve and endothelial function late after Kawasaki disease. J Pediatr. 2003 Feb;142(2):149-54. doi: 10.1067/mpd.2003.46.
- Background: PubMed 12505222de Jongh S, Lilien MR, op't Roodt J, Stroes ES, Bakker HD, Kastelein JJ. Early statin therapy restores endothelial function in children with familial hypercholesterolemia. J Am Coll Cardiol. 2002 Dec 18;40(12):2117-21. doi: 10.1016/s0735-1097(02)02593-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arturo Borzutzky, MD principal investigator
Pontificia Universidad Catolica de Chile, School of Medicine, Department of Pediatrics
Miguel Gutierrez, MD study director
Pontificia Universidad Catolica de Chile, School of Medicine, Department of Rheumatology and Clinical Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pravastatin in people with Kawasaki Disease, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of change in brachial artery dilatation after statin therapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00305201, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2016.