Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)
NCT ID: NCT03767322
Last Updated: 2018-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
558 participants
INTERVENTIONAL
2018-12-05
2019-12-31
Brief Summary
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Detailed Description
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Exclusion criteria: patients under treatment with allopurinol or febuxostat in the previous seven days, known allergy to allopurinol or febuxostat, patients on renal replacement therapy
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Allopurinol group
The intervention group will receive 300 mg of allopurinol 12 hours before and 12 hours after the coronary intervention.
Allopurinol
Eligible patients will receive allopurinol 300 mg before and after coronary intervention
Placebo group
The placebo group will receive 300 mg of placebo 12 hours before and 12 hours after the coronary intervention.
Placebo
Eligible patients will receive before and after coronary intervention
Febuxostat group
The intervention group will receive 80 mg of febuxostat 12 hours before and 12 hours after the coronary intervention
Febuxostat
Eligible patients will receive febuxostat 80 mg before and after coronary intervention
Interventions
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Allopurinol
Eligible patients will receive allopurinol 300 mg before and after coronary intervention
Febuxostat
Eligible patients will receive febuxostat 80 mg before and after coronary intervention
Placebo
Eligible patients will receive before and after coronary intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with Mehran score \> 5 or modified Mehran score \>2 even glomerular filtration rate \> 60 ml/min (high risk patients)
* Glomerular Filtration Rate \< 60 ml/min
* All the patients provided written informed consent for the procedures and the test drug
Exclusion Criteria
* Patients under treatment with allopurinol of febuxostat
* Patients on renal replacement therapy
* Known allergy to allopurinol or febuxostat
18 Years
100 Years
ALL
No
Sponsors
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Salvador López Gil
UNKNOWN
Armando Vázquez Rangel
UNKNOWN
Instituto Nacional de Cardiologia Ignacio Chavez
OTHER
Responsible Party
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Magdalena Madero
Nephrology Department
Principal Investigators
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Magdalena Madero, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Cardiologia Ignacio Chavez
Locations
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Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, México City, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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Ghelich Khan Z, Talasaz AH, Pourhosseini H, Hosseini K, Alemzadeh Ansari MJ, Jalali A. Potential Role of Allopurinol in Preventing Contrast-Induced Nephropathy in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Placebo-Controlled Trial. Clin Drug Investig. 2017 Sep;37(9):853-860. doi: 10.1007/s40261-017-0542-z.
Kumar A, Bhawani G, Kumari N, Murthy KS, Lalwani V, Raju ChN. Comparative study of renal protective effects of allopurinol and N-acetyl-cysteine on contrast induced nephropathy in patients undergoing cardiac catheterization. J Clin Diagn Res. 2014 Dec;8(12):HC03-7. doi: 10.7860/JCDR/2014/9638.5255. Epub 2014 Dec 5.
Mendi MA, Afsar B, Oksuz F, Turak O, Yayla C, Ozcan F, Johnson RJ, Kanbay M. Uric Acid is a Useful Tool to Predict Contrast-Induced Nephropathy. Angiology. 2017 Aug;68(7):627-632. doi: 10.1177/0003319716639187. Epub 2016 Mar 22.
Shibagaki Y, Ohno I, Hosoya T, Kimura K. Safety, efficacy and renal effect of febuxostat in patients with moderate-to-severe kidney dysfunction. Hypertens Res. 2014 Oct;37(10):919-25. doi: 10.1038/hr.2014.107. Epub 2014 Jun 19.
Fukui T, Maruyama M, Yamauchi K, Yoshitaka S, Yasuda T, Abe Y. Effects of Febuxostat on Oxidative Stress. Clin Ther. 2015 Jul 1;37(7):1396-401. doi: 10.1016/j.clinthera.2015.03.026. Epub 2015 Apr 23.
Other Identifiers
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PT-18-081
Identifier Type: -
Identifier Source: org_study_id
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