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| Name | Class |
|---|---|
| Cumberland Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous NAC | Drug | intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CIN | 48-72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| in-hospital mortality | 30 days | |
| 30 day mortality | 30 days | |
| duration of hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arthur Grant, MD | Contact | (504) 842-6281 | agrant@ochsner.org | |
| Zehra Jaffery, MD | Contact | 504-842-7157 | zjaffery@ochsner.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Medical Center | Recruiting | New Orleans | Louisiana | 70121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21542122 | Derived | 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. |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Placebo | Drug | 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. |
|
| 30 days |
| serum cystatin C | 48-72 hours |
| D052801 | Male Urogenital Diseases |