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Trial record 70 of 251 for:    ASPIRIN AND low-dose aspirin

Multi-center Prospective Randomized Control Trail of High Dose Aspirin in Acute Stage of Kawasaki Disease

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ClinicalTrials.gov Identifier: NCT02359643
Recruitment Status : Unknown
Verified May 2013 by Chang Gung Memorial Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : February 10, 2015
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:

Kawasaki disease (KD) is an acute multi-system vasculitis syndrome of unknown etiology occurring mostly in infants and children younger than 5 years of age. In developed countries, it is the leading cause of acquired heart disease in children. However, KD remains a mysterious disease.

Single high dose intravenous immunoglobulin (IVIG, 2gm/kg) and aspirin are standard treatment for KD. Aspirin have been prescribed in treatment of KD for decade even earlier than usage of IVIG. High dose aspirin mainly act as anti-inflammation, while low dose aspirin as anti-platelet. IVIG may play most of the role of anti-inflammation in acute stage of KD. Hsieh et al. reported that KD without high dose aspirin had the same treatment response after IVIG. Therefore it is still unclear about the necessarily of high dose aspirin in acute stage of KD.

This study was conduct to investigate the role of high dose aspirin in acute stage of KD via a multi-center randomized control trail, and we plan to achieve the followings till year 2017:

  1. Enroll 300 KD patients from multiple medical centers . Randomize group patients as group 1: with high dose aspirin (more than 30/mg/kd/day) until fever subsided and shift to low dose aspirin (3-5mg/kg/day, N=150); and group 2: without high dose aspirin during acute febrile stage, only use low dose aspirin (N=150).
  2. Compare data including fever days, admission duration, laboratory data (CBC/DC, GOT/GPT, BUN/Cr, Alb, ESR, CRP, 2D echo), IVIG treatment response and CAL formation rate (followed at least 1 year).

Condition or disease Intervention/treatment Phase
Kawasaki Disease Drug: Aspirin Not Applicable

Detailed Description:

All subjects are children who fulfilled the criteria for KD and who are treated with IVIG at each hospital after informed contents are obtained. The patients are initially treated with a single dose of IVIG (2 g/kg) during a 12-hour period.

Principal clinical features of KD that occur in the acute stage within 5 days of the onset of fever will be recorded. After the informed content from the parents, PB samples will be obtained before IVIG treatment (pre-IVIG, KD1), within 3 days after complete initial IVIG treatment (post-IVIG, KD2) as the acute stage samples and then 1 month, 6 month and 12 month followed-up as subacute/convalescent stage samples. CAL was defined as the internal diameter being at least 3 mm of the coronary artery (4 mm if the subject was over the age of 5 years) or the internal diameter of a segment at least 1.5 times as large as that of an adjacent segment by echocardiogram.

High dose aspirin will be given (> 30 mg/kg/day) until the fever subsided at group 1 randomly. After fever subside (<38C, for 48 hours) low-dose aspirin (3-5 mg/kg/day) will be prescribed for all patients until all signs of inflammation resolved in both group 1 and 2.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center Prospective Randomized Control Trail of High Dose Aspirin in Acute Stage of Kawasaki Disease
Study Start Date : May 2013
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Placebo Comparator: with high dose aspirin
KD patients treated with high dose IVIG (2gm/kg) and high dose aspirin (>50mg/kg/day) since diagnosed, then taper to low dose aspirin (3-5mg/kg/day) when fever subside.
Drug: Aspirin

This study was conduct to investigate the role of high dose aspirin in acute stage of KD via a multi-center randomized control trail, and we plan to achieve the followings in the coming 4 years:

  1. Enroll 300 KD patients from multiple medical centers of Taiwan and China in 4 years. Randomize group patients as group 1: with high dose aspirin (more than 30/mg/kd/day) until fever subsided and shift to low dose aspirin (3-5mg/kg/day, N=150); and group 2: without high dose aspirin during acute febrile stage, only use low dose aspirin (N=150).
  2. Compare data including fever days, admission duration, laboratory data (CBC/DC, GOT/GPT, BUN/Cr, Alb, ESR, CRP, 2D echo), IVIG treatment response and CAL formation rate (followed at least 1 year).
Other Name: acetylsalicylic acid

Experimental: Without high dose aspirin
KD patients treated with high dose IVIG (2gm/kg) without high dose aspirin (>50mg/kg/day) since diagnosed, then low dose aspirin (3-5mg/kg/day) when fever subside.
Drug: Aspirin

This study was conduct to investigate the role of high dose aspirin in acute stage of KD via a multi-center randomized control trail, and we plan to achieve the followings in the coming 4 years:

  1. Enroll 300 KD patients from multiple medical centers of Taiwan and China in 4 years. Randomize group patients as group 1: with high dose aspirin (more than 30/mg/kd/day) until fever subsided and shift to low dose aspirin (3-5mg/kg/day, N=150); and group 2: without high dose aspirin during acute febrile stage, only use low dose aspirin (N=150).
  2. Compare data including fever days, admission duration, laboratory data (CBC/DC, GOT/GPT, BUN/Cr, Alb, ESR, CRP, 2D echo), IVIG treatment response and CAL formation rate (followed at least 1 year).
Other Name: acetylsalicylic acid




Primary Outcome Measures :
  1. To assess total hospital day [ Time Frame: 5-10 days ]

Secondary Outcome Measures :
  1. To assess total fever duration [ Time Frame: 5-10 days ]
  2. To assess how many times of intramenous immunoglobulin (IVIG) treatment [ Time Frame: 21 days ]
    IVIG resistance: more than 2 times of IVIG (2gm/kg); or IVIG responsive: only treatment with one time of IVIG (2gm/kg)

  3. To examine whether coronary artery lesion formation (CAL) [ Time Frame: 6-8 weeks ]
    CAL was defined as the internal diameter being at least 3 mm of the coronary artery (4 mm if the subject was over the age of 5 yr) or the internal diameter of a segment at least 1.5 times as large as that of an adjacent segment by echocardiogram



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: (both 1 and 2)

1. All subjects are children who fulfilled the criteria for Kawasaki Disease (American Heart Association criteria).

  1. Fever > 5 days, and 4 of the 5 following symptoms
  2. Diffuse mucosal inflammation (strawberry tongue, dry and fissured lips)
  3. Bilateral non-purulent conjunctivitis,
  4. Dysmorphous skin rashes,
  5. Indurative angioedema over the hands and feet
  6. Cervical lymphadenopathy. (One or more nodule at lease 1.5 cm in diameter) 2. KD patients are treated with IVIG at each hospital after informed contents are obtained.

Exclusion Criteria:

  1. Patients whose symptoms did not full fit the Kawasaki Disease criteria.
  2. Had an acute fever for < 5 days and >10 days
  3. Incomplete collection of each followed-up data (CBC/DC, GOT/GPT, BUN/Cr, Albumin, ESR, C-Reactive Protein, 2D echocardiography)
  4. IVIG treatment at other hospital before refers to study centers.
  5. Treatment with corticosteroids, other than inhaled forms, in the previous 2 weeks before enrollment;
  6. The presence of a disease known to mimic Kawasaki disease.
  7. Previous diagnosis of Kawasaki disease
  8. Inability to take aspirin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359643


Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Chair: Ho-Chang Kuo, MD, PhD Chang Gung Memorial Hospital

Publications:
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02359643     History of Changes
Other Study ID Numbers: Kawasaki Disease
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: May 2013

Keywords provided by Chang Gung Memorial Hospital:
Kawasaki disease

Additional relevant MeSH terms:
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Aspirin
Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics