NCT01820195

Brief Summary

There are many controversies about the role of N-Acetyl Cystein in preventing of contrast nephropathy. These contradictory results may be due to different criteria for patients' selection, different end points, different type and dose of N-Acetyl Cystein administration and finally different prophylactic measures other than N-Acetyl Cystein. The investigators try to enroll a double blind double dummy study with a good power to compare the effect of this drug both in the form of oral and intravenous against the placebo in preventing the contrast nephropathy in the patients whom undergo coronary angiography/angioplasty.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
549

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 28, 2013

Status Verified

March 1, 2013

Enrollment Period

1.4 years

First QC Date

March 25, 2013

Last Update Submit

March 27, 2013

Conditions

Chronic Kidney Disease Stage 2Radiographic Contrast Agent Nephropathy

Keywords

Contrast NephropathyN-Acetyl CysteinProphylaxy

Outcome Measures

Primary Outcomes (1)

  • Increase in serum creatinine more than 25% of baseline

    24 hours, 48 hours after exposure to contrast media

Secondary Outcomes (1)

  • Increase in serum creatinine more than 25% of baseline

    The 5th day after exposure to contrast media

Study Arms (3)

Intravenous N Acetyl Cystein

ACTIVE COMPARATOR

1200 mg IV N- Acetyl Cystein half an hour before contrast administration. This group will also take oral placebo

Drug: IV N-Acetyl Cystein

Placebo

PLACEBO COMPARATOR

Patients on both oral placebo and IV placebo just like patients on oral and IV N-acetyl cystein groups in regard of dose and timing.

Drug: Placebo group

Oral N Acetyl Cystein

ACTIVE COMPARATOR

Patients on 600 mg oral N-Acetyl Cystein bid started at the day before contrast exposure and continue until the next day of contrast exposure.These patients will also take IV placebo

Drug: Oral N-Acetyl Cystein

Interventions

Oral N-Acetyl CysteinDRUG

Oral N-Acetyl Cystein 600 mg bid started the day before contrast administration and continue the day after exposure to contrast

Oral N Acetyl Cystein
IV N-Acetyl CysteinDRUG

Bolus IV administration of 1200 mg N- Acetyl Cystein half an hour before contrast media administration

Intravenous N Acetyl Cystein
Placebo groupDRUG

The patients in this group will be received both oral placebo and IV placebo

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age more than 18
  • chronic Kidney disease stage 2-4
  • use of nephrotoxins in last week leading to angiography

You may not qualify if:

  • Acute kidney injury
  • concomitant use of other nephrotoxins
  • need of repeated imaging with contrast in five days after the first surgery
  • need for surgery in next five day after the contrast exposure
  • need of using nephrotoxins in next five days after contrast exposure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran Heart Center

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohammad R Khatami, MD

    Nephrology Research Center

    STUDY CHAIR

  • Ebrahin Kassaian, MD

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Mojtaba Salarifar, MD

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

  • Ali Kazemi-Saeid, MD

    Tehran Heart Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad R Khatami, MD

CONTACT

khatamis@sina.tums.ac.ir

Ebrahim Kassaeian, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 25, 2013

First Posted

March 28, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2014

Study Completion

November 1, 2014

Last Updated

March 28, 2013

Record last verified: 2013-03

Locations

IR(1)