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Vitamin E and N-acetylcysteine for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization

Primary Purpose

Coronary Artery Disease, Coronary Artery Angiography, Coronary Catheterization

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vitamin E
N-acetyl cysteine
Placebo oral capsule
Placebos
Normal Saline Flush, 0.9% Injectable Solution
Sponsored by
Rajaie Cardiovascular Medical and Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rajaie cardiovascular medical and research centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Vitamin E

NAC

Arm Description

Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization combined with the placebos of both vitamin E and NAC (i.e. the placebo of vitamin E as a soft gel capsule and the placebo of NAC as an effervescent tablets along with a glass of water with the same consumption order used in the groups 2 and 3, respectively).

Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization combined with vitamin E 800 IU orally 2 hours before intervention and 400 IU orally 4 hours after intervention plus the placebo of NAC with a consumption order similar to group 3.

Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization combined with NAC 1200 mg orally 2 hours before intervention and 1200 mg orally 4 hours after intervention plus the placebo of vitamin E with the consumption order similar to group 2.

Outcomes

Primary Outcome Measures

Contrast-induced acute kidney injury
Contrast-induced acute kidney injury defined as an absolute increase ≥0.5 mg/dL or a relative increase ≥25% over baseline serum creatinine concentration within 48-72 hours after administration of contrast media.

Secondary Outcome Measures

Changes in the levels of serum creatinine
Changes in serum creatinine after coronary artery catheterization
eGFR within 48-72 hours after coronary catheterization
Changes in eGFR after coronary artery catheterization
Changes in complete blood cell count components from baseline to follow-up
Changes in complete blood cell count components after coronary artery catheterization
Length of hospital stay
Length of hospital stay
Requirement for renal replacement therapies
Requirement for renal replacement therapies, ie, any kind of dialysis or renal transplantation
Post-procedure acute coronary syndrome (ACS) events
Recurrent acute coronary syndrome after coronary artery catheterization
Post-procedure cerebrovascular events
Cerebrovascular events after coronary artery catheterization
In-hospital mortality
In-hospital mortality after coronary artery catheterization
Post-procedure atrial fibrillation
Atrial fibrillation after coronary artery catheterization
Post-procedure bleeding
Bleeding events after coronary artery catheterization
Pulmonary embolism
Pulmonary embolism after coronary artery catheterization
Re-intervention
Repeated coronary artery catheterization

Full Information

First Posted
November 25, 2018
Last Updated
November 29, 2018
Sponsor
Rajaie Cardiovascular Medical and Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03755700
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajaie Cardiovascular Medical and Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Artery Angiography, Coronary Catheterization, Contrast-induced Nephropathy, Stable Angina, Acute Coronary Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization combined with the placebos of both vitamin E and NAC (i.e. the placebo of vitamin E as a soft gel capsule and the placebo of NAC as an effervescent tablets along with a glass of water with the same consumption order used in the groups 2 and 3, respectively).
Arm Title
Vitamin E
Arm Type
Active Comparator
Arm Description
Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization combined with vitamin E 800 IU orally 2 hours before intervention and 400 IU orally 4 hours after intervention plus the placebo of NAC with a consumption order similar to group 3.
Arm Title
NAC
Arm Type
Active Comparator
Arm Description
Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization combined with NAC 1200 mg orally 2 hours before intervention and 1200 mg orally 4 hours after intervention plus the placebo of vitamin E with the consumption order similar to group 2.
Intervention Type
Drug
Intervention Name(s)
Vitamin E
Intervention Description
As a gel capsule of vitamin E 800 IU orally 2 hours before intervention and 400 IU orally 4 hours after intervention
Intervention Type
Drug
Intervention Name(s)
N-acetyl cysteine
Intervention Description
As an effervescent tablets of NAC 1200 mg orally 2 hours before intervention and 1200 mg orally 4 hours after intervention
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
The placebo of vitamin E as a soft gel capsule with the consumption order similar to vitamin e group
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
The placebo of n-acetylcysteine as a tablet with the consumption order similar to n-acetylcysteine group
Intervention Type
Drug
Intervention Name(s)
Normal Saline Flush, 0.9% Injectable Solution
Intervention Description
Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization
Primary Outcome Measure Information:
Title
Contrast-induced acute kidney injury
Description
Contrast-induced acute kidney injury defined as an absolute increase ≥0.5 mg/dL or a relative increase ≥25% over baseline serum creatinine concentration within 48-72 hours after administration of contrast media.
Time Frame
48 to 72 hours after coronary catheterization
Secondary Outcome Measure Information:
Title
Changes in the levels of serum creatinine
Description
Changes in serum creatinine after coronary artery catheterization
Time Frame
48-72 hours post-procedure
Title
eGFR within 48-72 hours after coronary catheterization
Description
Changes in eGFR after coronary artery catheterization
Time Frame
48-72 hours post-procedure
Title
Changes in complete blood cell count components from baseline to follow-up
Description
Changes in complete blood cell count components after coronary artery catheterization
Time Frame
48-72 hours post-procedure
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
48-72 hours post-procedure
Title
Requirement for renal replacement therapies
Description
Requirement for renal replacement therapies, ie, any kind of dialysis or renal transplantation
Time Frame
48-72 hours post-procedure
Title
Post-procedure acute coronary syndrome (ACS) events
Description
Recurrent acute coronary syndrome after coronary artery catheterization
Time Frame
48-72 hours post-procedure
Title
Post-procedure cerebrovascular events
Description
Cerebrovascular events after coronary artery catheterization
Time Frame
48-72 hours post-procedure
Title
In-hospital mortality
Description
In-hospital mortality after coronary artery catheterization
Time Frame
48-72 hours post-procedure
Title
Post-procedure atrial fibrillation
Description
Atrial fibrillation after coronary artery catheterization
Time Frame
48-72 hours post-procedure
Title
Post-procedure bleeding
Description
Bleeding events after coronary artery catheterization
Time Frame
48-72 hours post-procedure
Title
Pulmonary embolism
Description
Pulmonary embolism after coronary artery catheterization
Time Frame
48-72 hours post-procedure
Title
Re-intervention
Description
Repeated coronary artery catheterization
Time Frame
48-72 hours post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yousef Rezaei, MD
Phone
+98 91 2623 1864
Email
yousefrezaei1986@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bahram Mohebbi, MD
Phone
+ 98 21 2392
Ext
2072
Email
roodbar@yahoo.com
Facility Information:
Facility Name
Rajaie cardiovascular medical and research center
City
Tehran
ZIP/Postal Code
1995614331
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Majid Maleki, MD
Phone
+98 21 2392
Ext
2043
Email
research@rhc.ac.ir

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27068631
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.
Results Reference
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PubMed Identifier
28279510
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.
Results Reference
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Vitamin E and N-acetylcysteine for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization

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