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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 5, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: N-acetyl cysteine
Drug: Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of N-acetyl Cysteine on Periprocedural Myocardial Infarction and Major Cardiac and Cerebral Events in Patients Undergoing Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by Suleyman Demirel University:

Primary Outcome Measures:
  • periprocedural myocardial infarction [ Time Frame: postprocedural 3-6 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: saline
30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure
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
Drug: N-acetyl cysteine

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878669

Locations
Turkey
Suleyman Demirel University Recruiting
Isparta, Mediterranean Region, Turkey, 32260
Contact: Dogan Erdogan, deputy chief physician    +0902462324479 ext 1140    aydoganer@hotmail.com   
Principal Investigator: mehmet ozaydin, MD         
Sub-Investigator: ibrahim ersoy, MD         
Sponsors and Collaborators
Suleyman Demirel University
  More Information

No publications provided

Responsible Party: Mehmet Ozaydin, MD, MD, Professor, Suleyman Demirel University
ClinicalTrials.gov Identifier: NCT01878669     History of Changes
Other Study ID Numbers: ozaydin289
Study First Received: March 26, 2013
Last Updated: October 5, 2014
Health Authority: Turkey: Ethics Committee

Keywords provided by Suleyman Demirel University:
n-acetyl cysteine
percutaneous coronary intervention

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on October 19, 2014