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

NCT03755700 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2018-11-30

No results posted yet for this study

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

Interventions

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

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

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

Sponsors & Collaborators

  • Rajaie Cardiovascular Medical and Research Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Iran

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03755700 on ClinicalTrials.gov