|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Ochsner Health System |
|---|---|
| Information provided by: | Ochsner Health System |
| ClinicalTrials.gov Identifier: | NCT00939913 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Nephropathy |
Drug: intravenous NAC Drug: Placebo comparator |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | N-Acetylcysteine to Prevent Contrast-Induced Nephropathy in Acute Coronary Syndromes |
| Estimated Enrollment: | 400 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours)
|
|
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 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Arthur Grant, MD | (504) 842-6281 | agrant@ochsner.org |
| Contact: Zehra Jaffery, MD | 504-842-7157 | zjaffery@ochsner.org |
| United States, Louisiana | |
| Ochsner Medical Center | Recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| Contact: Arthur G Grant, MD 504-842-6281 agrant@ochsner.org | |
| Principal Investigator: Arthur G Grant, MD | |
More Information
| Responsible Party: | Ochsner medical center ( Arthur G. Grant MD ) |
| Study ID Numbers: | IRB#2006.212.A |
| Study First Received: | July 14, 2009 |
| Last Updated: | July 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00939913 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
contrast nephropathy, intravenous n-acetlycysteine |
|
Urologic Diseases Acute Coronary Syndrome Acetylcysteine Kidney Diseases N-monoacetylcystine |
|
Urologic Diseases Kidney Diseases |
