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Efficacy of Vitamin E in Preventing Contrast-Induced Acute Kidney Injury Following Coronary Angiography

U

Urmia University of Medical Sciences

Status and phase

Completed
Phase 3

Conditions

Unstable Angina
Stable Angina
Post MI
Non ST Segment Elevation Myocardial Infarction

Treatments

Drug: Vitamin E

Study type

Interventional

Funder types

Other

Identifiers

NCT02070679
UMSU-Cardiology-1

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of vitamin E on preventing from incidence of contrast induced acute kidney injury (CI-AKI) in the patients who undergone coronary angiography.

Enrollment

284 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. All patients whon have either stable coronary artery disease (CAD) or recent acute coronary disease (ACS) and are scheduled for coronary angiography.
  2. Patients who have eGFR ≤60 ml/min/1.73 m2

Exclusion criteria

  1. Allergy to contrast media
  2. Cardiogenic shock
  3. Pulmonary edema
  4. Overt cardiac failure or left ventricular ejection fraction ≤ 30%
  5. Acute kidney injury
  6. The history of receiving contrast media for any medical diagnostic or therapeutic procedures during previous 5 days
  7. The history of dialysis
  8. Being pregnant
  9. Having recent acute myocardial infarction
  10. Taking antioxidants and nephrotoxic drugs including NSAID and ACE-I on previous 2 days

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

284 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Vit-E
Active Comparator group
Description:
600 IU on 12 hours before angiography and 400 IU on 2 hours before angiography
Treatment:
Drug: Vitamin E

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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