Effects of N-acetyl Cysteine During Percutaneous Coronary Intervention (EASE-PCI)

This study is currently recruiting participants.
Verified March 2014 by Suleyman Demirel University
Sponsor:
Information provided by (Responsible Party):
Mehmet Ozaydin, MD, Suleyman Demirel University
ClinicalTrials.gov Identifier:
NCT01878669
First received: March 26, 2013
Last updated: March 13, 2014
Last verified: March 2014

March 26, 2013
March 13, 2014
January 2013
January 2015   (final data collection date for primary outcome measure)
periprocedural myocardial infarction [ Time Frame: postprocedural 3-6 h ] [ Designated as safety issue: No ]
periprocedural myocardial infarction [ Time Frame: postprocedural 3-6 h and 24 h ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01878669 on ClinicalTrials.gov Archive Site
  • NAC side effects (Asthma exacerbation, pruritus, dyspnea) [ Time Frame: during hospitalization at 48 hours ] [ Designated as safety issue: Yes ]
  • major cardiac and cerebral events [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of N-acetyl Cysteine During Percutaneous Coronary Intervention
Effects of N-acetyl Cysteine on Periprocedural Myocardial Infarction and Major Cardiac and Cerebral Events in Patients Undergoing Percutaneous Coronary Intervention

The aim of this study is to evaluate the effects of N-acetyl cysteine on periprocedural myocardial infarction and major cardiac and cerebral events in patients undergoing percutaneous coronary intervention and who have moderate to high risk for contrast induced nephropathy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Coronary Artery Disease
  • Drug: N-acetyl cysteine
  • Drug: Saline
  • Placebo Comparator: saline
    30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure
    Intervention: Drug: Saline
  • Experimental: n-acetyl cysteine
    30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure
    Intervention: Drug: N-acetyl cysteine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Not Provided
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients > 18 years old undergoing percutaneous coronary intervention and who have moderate to high risk for contrast induced nephropathy (Mehran Score ≥ 5)

Exclusion Criteria:

  • Primary percutaneous coronary intervention
  • Low risk for contrast induced nephropathy (Mehran Score < 5)
  • Use of nephrotoxic agents (NSAIDs, aminoglycosides,recent contrast injection...)
  • Infection
  • Pregnancy, Lactation
  • Renal failure requiring dialysis
  • Hepatic failure
  • History allergy for NAC
  • History of Asthma
  • Chronic nitrate usage
  • Malignancy
  • Use of corticosteroids
  • Leukocytosis,Thrombocytosis,Anemia
  • Blood pressure of >180/100mmHg despite anti-hypertensive therapy
Both
18 Years to 85 Years
No
Not Provided
Turkey
 
NCT01878669
ozaydin289
No
Mehmet Ozaydin, MD, Suleyman Demirel University
Suleyman Demirel University
Not Provided
Not Provided
Suleyman Demirel University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP