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Allopurinol and Trimetazidine as a Preventive of Acute Kidney Injury in PCI Patients

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ClinicalTrials.gov Identifier: NCT05540184
Recruitment Status : Not yet recruiting
First Posted : September 14, 2022
Last Update Posted : September 15, 2022
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Mohamed Emam abd Elmobdy, Beni-Suef University

Brief Summary:
Contrast-associated acute kidney injury (CA-AKI) is a common complication of procedures with intravascular contrast. Generally, CA-AKI is defined as serum creatinine (Scr) ≥ 25 to 50% or Scr rise around 0.3 to 0.5 mg/dl. The initial rise in SCr is typically seen within 48 to 72 h of contrast exposure .CA-AKI has been associated with increased hospital length of stay and excess costs. Therefore, the prevention of CA-AKI is beneficial for minimizing hospital costs, mortality and morbidity. Till now, what is clearly beneficial in CIN is adequate hydration before and after coronary angiography However, further measures are trialed, aiming to reduce more morbidity and mortality. There is a great deal of publications pertaining to the possible therapeutic interventions to avoid the ultimate outcome of complete kidney failure. Accordingly, allopurinol has been suggested as a promising measure for the prevention of acute kidney injury after coronary angiography through protecting the kidney by inhibiting XO activity and blocking the generation of oxygen radicals. However, studies have shown conflicting results. Trimetazidine is cellular anti-ischemic drug which has been shown to protect against free radical damage due to its antioxidant activity. It has been recently shown to decrease the risk of CIN in percutaneous coronary intervention (PCI) in some studies. However, it is worth mentioning that studies evaluating trimetazidine under presented patients with high estimated glomerular filtration rate (eGFR). Accordingly, Aimed to evaluate the combination of trimetazidine with allopurinol versus using trimetazidine alone to define the most effective strategy to be implemented in the clinical setting in patients with diverse risk factors and normal GFR.

Condition or disease Intervention/treatment Phase
AKI - Acute Kidney Injury Drug: Trimetazidine 35 mg Drug: Allopurinol 300 MG Drug: Normal saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Allopurinol and Trimetazidine as a Preventive of Contrast-associated Acute Kidney Injury in Patients Undergoing Percutaneous Coronary Intervention
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025


Arm Intervention/treatment
Experimental: Hydration plus Trimetazidine
Hydration plus Trimetazidine 35mg twice daily will be given to patients before the procedure and 24 hours after the procedure
Drug: Trimetazidine 35 mg
Trimetazidine 35mg twice daily will be given to patients before the procedure and 24 hours after the procedure
Other Name: Vastarel MR

Drug: Normal saline
rate of 1 mL/kg per hour (3 to 4 hrs before the procedure and up to 24 hours post-procedure, maximum 100 ml/hr)
Other Name: 0.9 NS

Experimental: Hydration ,Trimetazidine & allopurinol
Hydration plus Trimetazidine 35mg once daily will be given to patients before the procedure and up to 24 hours after the procedure and allopurinol 300 mg once daily 5 hours before the procedure and next day of the procedure
Drug: Trimetazidine 35 mg
Trimetazidine 35mg twice daily will be given to patients before the procedure and 24 hours after the procedure
Other Name: Vastarel MR

Drug: Allopurinol 300 MG
allopurinol 300 mg once daily 5 hours before the procedure and next day of the procedure
Other Name: Zyloric 300mg

Drug: Normal saline
rate of 1 mL/kg per hour (3 to 4 hrs before the procedure and up to 24 hours post-procedure, maximum 100 ml/hr)
Other Name: 0.9 NS

Placebo Comparator: Hydration
Hydration only will be given to the patients normal saline at the rate of 1 mL/kg per hour (3 to 4 hrs before the procedure and up to 24 hours post-procedure, maximum 100 ml/hr)
Drug: Normal saline
rate of 1 mL/kg per hour (3 to 4 hrs before the procedure and up to 24 hours post-procedure, maximum 100 ml/hr)
Other Name: 0.9 NS




Primary Outcome Measures :
  1. Incidence of CIN [ Time Frame: 48-72 hours after PCI ]
    Incidence of CIN


Secondary Outcome Measures :
  1. Change in SCr, within 48 hrs after the procedure [ Time Frame: within 48 hrs after the procedure ]
    Change in SCr,within 48 hrs after the procedure

  2. Change in BUN within 48 hrs after the procedure [ Time Frame: within 48 hrs after the procedure ]
    Change in BUN within 48 hrs after the procedure

  3. Change in uric acid within 48 hrs after the procedure [ Time Frame: within 48 hrs after the procedure ]
    Change in uric acid within 48 hrs after the procedure

  4. Change in eGFR within 48 hrs after the procedure [ Time Frame: within 48 hrs after the procedure ]
    Change in eGFR within 48 hrs after the procedure



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients willing to undergo PCI with low, moderate or high risk of CIN based on Mehran risk score (4)
  • Age 18 - 80 years
  • Patients with GFR > 60 ml/min

Exclusion Criteria:

  • Age <18 or > 80 years
  • Acute kidney injury
  • Renal insufficiency (eGFR < 60 mL/min)
  • Gout (serum uric > 10 mg/dL)
  • History of allopurinol intake.
  • Hepatic failure.
  • Pregnancy or lactation,
  • History of allergy to contrast agents, allopurinol or trimetazidine
  • Any nephrotoxic drug intake within 48 hrs. before the procedure
  • Pulmonary edema, cardiogenic shock and mechanical ventilation.

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): NCT05540184


Contacts
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Contact: Nourhan Osama Ali Moselhy, BSc 01117115773 norhanossama15@yahoo.com
Contact: Naglaa Samir Bazan, Assoc. Prof 01005807504 naglaabazan@cu.edu.eg

Locations
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Egypt
Faculty of Pharmacy, Beni-Suef University
Banī Suwayf, Beni-Suef, Egypt, 62511
Sponsors and Collaborators
Beni-Suef University
Cairo University
Investigators
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Study Chair: Mohamed Emam abd Elmobdy, Professor clinical pharmacy Beni-Suef university
Principal Investigator: Naglaa Samir Bazan, Assoc. Prof clinical pharmacy critical care medicine, Cairo university
Principal Investigator: Hatem Hossam Mowafi, Doctor Lecturer critical care medicine , Cairo university
Study Director: Hadeer Safwat Hassan Zaki, Doctor Clinical Pharmacy, Beni-Suef University
Principal Investigator: Nourhan Osama Ali Moselhy, BSc Egyptian Drug Authority
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Responsible Party: Mohamed Emam abd Elmobdy, Professor of Clinical Pharmacy, Beni-Suef University, Beni-Suef University
ClinicalTrials.gov Identifier: NCT05540184    
Other Study ID Numbers: Allopurinol/Trimetazidine AKI
First Posted: September 14, 2022    Key Record Dates
Last Update Posted: September 15, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mohamed Emam abd Elmobdy, Beni-Suef University:
Trimetazidine
Allopurinol
acute kidney injury
PCI
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Allopurinol
Trimetazidine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents