NCT00939913

Brief Summary

In patients undergoing coronary angiography, the incidence of contrast induced nephropathy(CIN)varies widely and ranges from \< 5% in the lowest risk patients, to nearly 50% in the highest risk patients. Prior data has shown oral n-acetyl cysteine (NAC) to be effective in reducing the incidence of CIN.Due to extensive first pass metabolism, the bioavailability of oral NAC is poor and ranges from 4%-10%. We hypothesize that the incidence of CIN will be reduced in patients with ACS who undergo PCI by the prophylactic administration of intravenous NAC. This is a prospective, randomized, double-blind, placebo-controlled single center clinical trial designed to evaluate the effects of intravenous NAC on patients with acute coronary syndromes (ACS)undergoing coronary angiography and/or percutaneous coronary intervention (PCI). The medication Acetadote is provided by Cumberland Pharmaceuticals Inc (www.cumberlandpharma.com). Patients will be excluded if they have end-stage renal disease requiring dialysis,known hypersensitivity to NAC or a history of life-threatening contrast reaction. Primary end-point is incidence of CIN. Secondary end-points are in-hospital mortality,30-day mortality,duration of hospitalization and change in serum cystatin C level.

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
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2007

Typical duration for phase_4

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

January 1, 2007

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

3.3 years

First QC Date

July 14, 2009

Last Update Submit

September 17, 2009

Conditions

Nephropathy

Keywords

contrast nephropathyintravenous n-acetlycysteine

Outcome Measures

Primary Outcomes (1)

  • Incidence of CIN

    48-72 hours

Secondary Outcomes (4)

  • in-hospital mortality

    30 days

  • 30 day mortality

    30 days

  • duration of hospitalization

    30 days

  • serum cystatin C

    48-72 hours

Study Arms (2)

intravenous N-acetlycysteine

PLACEBO COMPARATOR

intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours)as compared to placebo Acetadote provided by Cumberland Pharmaceuticals Inc.

Drug: intravenous NAC

Placebo

PLACEBO COMPARATOR

Study participants will be randomized to receive an intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours) or placebo.

Drug: Placebo

Interventions

intravenous NACDRUG

intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours)

intravenous N-acetlycysteine
PlaceboDRUG

Study participants will be randomized to receive an intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours) or placebo.

Placebo

Eligibility Criteria

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

You may qualify if:

  • years of age or older.
  • Hospitalized with a primary diagnosis of acute coronary syndrome.
  • Scheduled for coronary angiography or intervention during the current hospitalization.

You may not qualify if:

  • Have end-stage renal disease (ESRD) requiring dialysis.
  • Have a known hypersensitivity to NAC.
  • Have a history of life-threatening contrast reaction. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

RECRUITING

Related Publications (1)

  • Jaffery Z, Verma A, White CJ, Grant AG, Collins TJ, Grise MA, Jenkins JS, McMullan PW, Patel RA, Reilly JP, Thornton SN, Ramee SR. A randomized trial of intravenous n-acetylcysteine to prevent contrast induced nephropathy in acute coronary syndromes. Catheter Cardiovasc Interv. 2012 May 1;79(6):921-6. doi: 10.1002/ccd.23157. Epub 2011 Nov 30.

    PMID: 21542122DERIVED

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Arthur Grant, MD

CONTACT

(504) 842-6281agrant@ochsner.org

Zehra Jaffery, MD

CONTACT

504-842-7157zjaffery@ochsner.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 15, 2009

Study Start

January 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

US(1)