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

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ClinicalTrials.gov Identifier: NCT03755700
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Rajaie Cardiovascular Medical and Research Center

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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Artery Angiography Coronary Catheterization Contrast-induced Nephropathy Stable Angina Acute Coronary Syndrome Drug: Vitamin E Drug: N-acetyl cysteine Drug: Placebo oral capsule Drug: Placebos Drug: Normal Saline Flush, 0.9% Injectable Solution Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Antioxidants for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Placebo Comparator: Placebo
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).
Drug: Placebo oral capsule
The placebo of vitamin E as a soft gel capsule with the consumption order similar to vitamin e group

Drug: Placebos
The placebo of n-acetylcysteine as a tablet with the consumption order similar to n-acetylcysteine group

Drug: Normal Saline Flush, 0.9% Injectable Solution
Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization

Active Comparator: Vitamin E
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.
Drug: Vitamin E
As a gel capsule of vitamin E 800 IU orally 2 hours before intervention and 400 IU orally 4 hours after intervention

Drug: Placebos
The placebo of n-acetylcysteine as a tablet with the consumption order similar to n-acetylcysteine group

Drug: Normal Saline Flush, 0.9% Injectable Solution
Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization

Active Comparator: NAC
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.
Drug: N-acetyl cysteine
As an effervescent tablets of NAC 1200 mg orally 2 hours before intervention and 1200 mg orally 4 hours after intervention

Drug: Placebo oral capsule
The placebo of vitamin E as a soft gel capsule with the consumption order similar to vitamin e group

Drug: Normal Saline Flush, 0.9% Injectable Solution
Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization




Primary Outcome Measures :
  1. Contrast-induced acute kidney injury [ Time Frame: 48 to 72 hours after coronary catheterization ]
    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 :
  1. Changes in the levels of serum creatinine [ Time Frame: 48-72 hours post-procedure ]
    Changes in serum creatinine after coronary artery catheterization

  2. eGFR within 48-72 hours after coronary catheterization [ Time Frame: 48-72 hours post-procedure ]
    Changes in eGFR after coronary artery catheterization

  3. Changes in complete blood cell count components from baseline to follow-up [ Time Frame: 48-72 hours post-procedure ]
    Changes in complete blood cell count components after coronary artery catheterization

  4. Length of hospital stay [ Time Frame: 48-72 hours post-procedure ]
    Length of hospital stay

  5. Requirement for renal replacement therapies [ Time Frame: 48-72 hours post-procedure ]
    Requirement for renal replacement therapies, ie, any kind of dialysis or renal transplantation

  6. Post-procedure acute coronary syndrome (ACS) events [ Time Frame: 48-72 hours post-procedure ]
    Recurrent acute coronary syndrome after coronary artery catheterization

  7. Post-procedure cerebrovascular events [ Time Frame: 48-72 hours post-procedure ]
    Cerebrovascular events after coronary artery catheterization

  8. In-hospital mortality [ Time Frame: 48-72 hours post-procedure ]
    In-hospital mortality after coronary artery catheterization

  9. Post-procedure atrial fibrillation [ Time Frame: 48-72 hours post-procedure ]
    Atrial fibrillation after coronary artery catheterization

  10. Post-procedure bleeding [ Time Frame: 48-72 hours post-procedure ]
    Bleeding events after coronary artery catheterization

  11. Pulmonary embolism [ Time Frame: 48-72 hours post-procedure ]
    Pulmonary embolism after coronary artery catheterization

  12. Re-intervention [ Time Frame: 48-72 hours post-procedure ]
    Repeated coronary artery catheterization



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


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): NCT03755700


Contacts
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Contact: Yousef Rezaei, MD +98 91 2623 1864 yousefrezaei1986@gmail.com
Contact: Bahram Mohebbi, MD + 98 21 2392 ext 2072 roodbar@yahoo.com

Locations
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Iran, Islamic Republic of
Rajaie cardiovascular medical and research center Recruiting
Tehran, Iran, Islamic Republic of, 1995614331
Contact: Majid Maleki, MD    +98 21 2392 ext 2043    research@rhc.ac.ir   
Sponsors and Collaborators
Rajaie Cardiovascular Medical and Research Center

Publications:
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Responsible Party: Rajaie Cardiovascular Medical and Research Center
ClinicalTrials.gov Identifier: NCT03755700     History of Changes
Other Study ID Numbers: Intervention-01
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Acute Kidney Injury
Angina, Stable
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Acetylcysteine
N-monoacetylcystine
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs