Clinical trial NCT03755700: Vitamin E and N-acetylcysteine for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization
Official title: Antioxidants for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Disease
Coronary Artery Angiography
Coronary Catheterization
Contrast-induced Nephropathy
Stable Angina
Acute Coronary Syndrome
Lead sponsor: Rajaie Cardiovascular Medical and Research Center
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In a double-blinded randomized clinical trial, all patients undergoing coronary artery catheterization who will met our criteria, will be enrolled into three groups to receive either, vitamin e, n-acetylcysteine, or placebo. The aim of study will be to compare the superiority of vitamin e over n-acetylcysteine for the prevention of contrast-induced acute kidney injury (CIAKI).

Detailed description: Patients aged ≥18 years with chronic kidney disease who undergo coronary catheterization will be enrolled into the study if they meet the inclusion criteria. Patients will be randomly assigned into three groups in a 1:1:1 ratio (Computer-generated random number will be used to assign a patient in either group): we will use simple randomization for assigning each patient in a group. The participants, physicians and outcome assessors will be blinded throughout the trial until the opening of the randomization cold.

All patients will be entered into three group and they will be given normal saline 0.9%, vitamin E, NAC, and the placebos of both regimens. The vitamin E will be given as a soft gel capsule and its placebo will have the same shape and taste. The NAC will be given as an effervescent tablet with a glass of water for consumption and its placebo will also have the same shape and taste. These drugs will be given in addition to the routine hydration therapy which will be given to all patients.

Primary outcome will be the development of CIAKI. Secondary outcomes will be the development of major adverse cardiovascular events and any events till evaluating the CIAKI within 48-72 hours after intervention.

Eligibility criteria: Inclusion Criteria:

Patients aged ≥18 years with baseline estimated glomerular filtration rate (eGFR) \<60 mL/min per 1.73 m2 (based on the Modification of Diet in Renal Disease study group formula) who undergo coronary catheterization (i.e. coronary angiography and percutaneous coronary intervention \[PCI\]) will be invited to the study if they meet the inclusion criteria: stable angina with ischemia and indication for coronary angiography, non-ST-segment elevation (NSTE) acute coronary syndrome (ACS) requiring an early invasive strategy, and patients undergoing elective PCI .

Exclusion Criteria:

acute ST-segment elevation myocardial infarction, high-risk NSTE-ACS warranting emergency coronary angiography (\<2 hours), cardiogenic shock, pulmonary edema, overt heart failure and/or ejection fraction \<30%, ACS undergoing coronary angiography or angioplasty during the previous 5 days, sensitivity to contrast medium, recent administration of contrast medium for any reason, AKI, history of dialysis, pregnancy, newly prescribed angiotensin converting enzyme inhibitors or angiotensin receptor blockers, bleeding and/or coagulopathy diseases, and consumption of nephrotoxic drugs, vitamin E, vitamin C, or N-acetylcysteine (NAC) at least 48 hours before intervention.

Primary outcomes:
measure: Contrast-induced acute kidney injury
timeFrame: 48 to 72 hours after coronary catheterization
Secondary outcomes:
measure: Changes in the levels of serum creatinine
timeFrame: 48-72 hours post-procedure
measure: eGFR within 48-72 hours after coronary catheterization
timeFrame: 48-72 hours post-procedure
measure: Changes in complete blood cell count components from baseline to follow-up
timeFrame: 48-72 hours post-procedure
measure: Length of hospital stay
timeFrame: 48-72 hours post-procedure
measure: Requirement for renal replacement therapies
timeFrame: 48-72 hours post-procedure
measure: Post-procedure acute coronary syndrome (ACS) events
timeFrame: 48-72 hours post-procedure
measure: Post-procedure cerebrovascular events
timeFrame: 48-72 hours post-procedure
measure: In-hospital mortality
timeFrame: 48-72 hours post-procedure
measure: Post-procedure atrial fibrillation
timeFrame: 48-72 hours post-procedure
measure: Post-procedure bleeding
timeFrame: 48-72 hours post-procedure
measure: Pulmonary embolism
timeFrame: 48-72 hours post-procedure
measure: Re-intervention
timeFrame: 48-72 hours post-procedure
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rajaie cardiovascular medical and research center
Study officials:
References:
citation: Rezaei Y, Khademvatani K, Rahimi B, Khoshfetrat M, Arjmand N, Seyyed-Mohammadzad MH. Short-Term High-Dose Vitamin E to Prevent Contrast Medium-Induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Elective Coronary Angiography: A Randomized Placebo-Controlled Trial. J Am Heart Assoc. 2016 Mar 15;5(3):e002919. doi: 10.1161/JAHA.115.002919.
citation: Rezaei Y, Hemila H. Vitamins E and C May Differ in Their Effect on Contrast-Induced Acute Kidney Injury. Am J Kidney Dis. 2017 May;69(5):708-709. doi: 10.1053/j.ajkd.2016.12.022. Epub 2017 Mar 6. No abstract available.