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Statins and Interleukin-1 (IL-1) Inhibitor

Atorvastatin + Anakinra for Kawasaki Disease

Q: Who has been deemed eligible to participate in this experiment?

This study is looking to include 10 individuals between the age of 1 and 17 who are dealing with mucocutaneous lymph node syndrome. To be eligible, they must meet a specific set of standards, such as having an Acute Kawasaki disease with LAD or RCA Z scores that exceed 3.

Q: To what medical conditions are Atorvastatin and anakinra commonly administered?

Atorvastatin and anakinra are primarily prescribed to control lipidemias. Other indications for these medications include the prevention of postoperative thromboembolism, alleviation of anginal <a href="https://www.withpower.com/clinical-trials/pain">pain</a>, and management of transient ischemic attack.

Q: Is this experiment the initial one of its variety?

Atorvastatin and anakinra have been investigated since 2005 when Merck Sharp &#x26; Dohme LLC sponsored the initial study. The tandem achieved its Phase 4 drug approval after a first trial involving 80 participants was completed. Currently, 102 trials for this combination of medications are being conducted in 347 cities across 48 different countries worldwide.

Q: Are there opportunities to join this experiment at the present time?

Indeed, clinicaltrials.gov indicates that this experiment is still accepting participants. This trial was posted on October 9th 2017 and last updated on March 1st 2022 with the need for 10 individuals from one site.

Q: To what extent has recruitment for this clinical trial been successful?

Affirmative. The research project, which was initially shared on the 9th of October 2017 and has been recently updated on March 1st 2022, is actively hunting for 10 test subjects from a single study centre according to clinicaltrials.gov's data.

Q: Is admittance to this experiment restricted to those aged eighteen or higher?

As per the study's eligibility requirements, any participant must be at least 1 year in age and no older than 17 years.

Phase < 1

Waitlist Available

Led By Adriana Tremoulet, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acute Kawasaki disease with a Z score of 3 or larger of the LAD or RCA

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial will study the effects of combination therapy with atorvastatin and anakinra in children with acute Kawasaki Disease and early coronary artery abnormalities.

Who is the study for?

This trial is for children with Kawasaki Disease who have developed coronary artery abnormalities, specifically with a Z score of 3 or larger in certain arteries. Children cannot participate if they are taking drugs metabolized by the enzyme CYP3A4, like cyclosporine.Check my eligibility

What is being tested?

The study tests whether atorvastatin and anakinra can reduce inflammation and prevent damage to the coronary arteries in children with acute Kawasaki Disease who already show early signs of arterial issues.See study design

What are the potential side effects?

Atorvastatin may cause muscle pain, digestive problems, and liver function changes. Anakinra might lead to injection site reactions, increased risk of infections, headaches, and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have Kawasaki disease with significant heart artery enlargement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with treatment-related adverse events

Trial Design

1Treatment groups

Experimental Treatment

Group I: Atorvastatin and anakinraExperimental Treatment1 Intervention

Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,120 Previous Clinical Trials

1,521,397 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,835 Previous Clinical Trials

47,310,632 Total Patients Enrolled

Adriana Tremoulet, MDPrincipal InvestigatorProfessor

Media Library

Atorvastatin and Anakinra (Statins and Interleukin-1 (IL-1) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04747847 — Phase < 1

Kawasaki Disease Research Study Groups: Atorvastatin and anakinra

Kawasaki Disease Clinical Trial 2023: Atorvastatin and Anakinra Highlights & Side Effects. Trial Name: NCT04747847 — Phase < 1

Atorvastatin and Anakinra (Statins and Interleukin-1 (IL-1) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04747847 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who has been deemed eligible to participate in this experiment?

"This study is looking to include 10 individuals between the age of 1 and 17 who are dealing with mucocutaneous lymph node syndrome. To be eligible, they must meet a specific set of standards, such as having an Acute Kawasaki disease with LAD or RCA Z scores that exceed 3."

Answered by AI

To what medical conditions are Atorvastatin and anakinra commonly administered?

"Atorvastatin and anakinra are primarily prescribed to control lipidemias. Other indications for these medications include the prevention of postoperative thromboembolism, alleviation of anginal pain, and management of transient ischemic attack."

Answered by AI

Is this experiment the initial one of its variety?

"Atorvastatin and anakinra have been investigated since 2005 when Merck Sharp & Dohme LLC sponsored the initial study. The tandem achieved its Phase 4 drug approval after a first trial involving 80 participants was completed. Currently, 102 trials for this combination of medications are being conducted in 347 cities across 48 different countries worldwide."

Answered by AI

Are there opportunities to join this experiment at the present time?

"Indeed, clinicaltrials.gov indicates that this experiment is still accepting participants. This trial was posted on October 9th 2017 and last updated on March 1st 2022 with the need for 10 individuals from one site."

Answered by AI

To what extent has recruitment for this clinical trial been successful?

"Affirmative. The research project, which was initially shared on the 9th of October 2017 and has been recently updated on March 1st 2022, is actively hunting for 10 test subjects from a single study centre according to clinicaltrials.gov's data."

Answered by AI