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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01878669
First Posted: June 17, 2013
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mehmet Ozaydin, MD, Suleyman Demirel University
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 Mehmet Ozaydin, MD, Suleyman Demirel University:

Primary Outcome Measures:
  • periprocedural myocardial infarction [ Time Frame: postprocedural 3-6 h ]

Secondary Outcome Measures:
  • NAC side effects (Asthma exacerbation, pruritus, dyspnea) [ Time Frame: during hospitalization at 48 hours ]
  • major cardiac and cerebral events [ Time Frame: 1 year follow-up ]

Estimated Enrollment: 390
Study Start Date: January 2013
Estimated Study Completion Date: June 2018
Primary Completion Date: September 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878669


Locations
Turkey
Suleyman Demirel University
Isparta, Mediterranean Region, Turkey, 32260
Sponsors and Collaborators
Suleyman Demirel University
  More Information

Responsible Party: Mehmet Ozaydin, MD, MD, Professor, Suleyman Demirel University
ClinicalTrials.gov Identifier: NCT01878669     History of Changes
Other Study ID Numbers: ozaydin289
First Submitted: March 26, 2013
First Posted: June 17, 2013
Last Update Posted: October 26, 2017
Last Verified: January 2017

Keywords provided by Mehmet Ozaydin, MD, 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
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes