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

NCT03755700 | Unknown Phase 3 DMC

• 1 other identifier: Intervention-01
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease; Coronary Artery Angiography; Coronary Catheterization; Contrast-induced Nephropathy; Stable Angina; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  48 to 72 hours after coronary catheterization

Secondary Outcomes (12)

• Changes in the levels of serum creatinine

  48-72 hours post-procedure

• eGFR within 48-72 hours after coronary catheterization

  48-72 hours post-procedure

• Changes in complete blood cell count components from baseline to follow-up

  48-72 hours post-procedure

• Length of hospital stay

  48-72 hours post-procedure

• Requirement for renal replacement therapies

  48-72 hours post-procedure

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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; Drug: Placebos; Drug: Normal Saline Flush, 0.9% Injectable Solution

Vitamin E

ACTIVE COMPARATOR

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; Drug: Placebos; Drug: Normal Saline Flush, 0.9% Injectable Solution

NAC

ACTIVE COMPARATOR

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; Drug: Placebo oral capsule; Drug: Normal Saline Flush, 0.9% Injectable Solution

Interventions

Vitamin E DRUG

As a gel capsule of vitamin E 800 IU orally 2 hours before intervention and 400 IU orally 4 hours after intervention

Vitamin E

N-acetyl cysteine DRUG

As an effervescent tablets of NAC 1200 mg orally 2 hours before intervention and 1200 mg orally 4 hours after intervention

NAC

Placebo oral capsule DRUG

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

NAC; Placebo

Placebos DRUG

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

Placebo; Vitamin E

Normal Saline Flush, 0.9% Injectable Solution DRUG

Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization

NAC; Placebo; Vitamin E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rajaie Cardiovascular Medical and Research Center: lead

Study Sites (1)

Rajaie cardiovascular medical and research center

Tehran, 1995614331, Iran

RECRUITING

Related Publications (2)

• 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.

  PMID: 27068631 BACKGROUND

• 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.

  PMID: 28279510 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Acute Coronary Syndrome

Interventions

Vitamin E; Acetylcysteine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Yousef Rezaei, MD

CONTACT

+98 91 2623 1864; yousefrezaei1986@gmail.com

Bahram Mohebbi, MD

CONTACT

+ 98 21 2392; roodbar@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: November 28, 2018
• Study Start: November 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

IR (1)