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

Primary Purpose

Coronary Artery Disease

Status
Active
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
N-acetyl cysteine
Saline
Sponsored by
Suleyman Demirel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring n-acetyl cysteine, percutaneous coronary intervention

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Suleyman Demirel University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

saline

n-acetyl cysteine

Arm Description

30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure

30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure

Outcomes

Primary Outcome Measures

periprocedural myocardial infarction

Secondary Outcome Measures

NAC side effects (Asthma exacerbation, pruritus, dyspnea)
major cardiac and cerebral events

Full Information

First Posted
March 26, 2013
Last Updated
August 7, 2023
Sponsor
Suleyman Demirel University
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1. Study Identification

Unique Protocol Identification Number
NCT01878669
Brief Title
Effects of N-acetyl Cysteine During Percutaneous Coronary Intervention
Acronym
EASE-PCI
Official Title
Effects of N-acetyl Cysteine on Periprocedural Myocardial Infarction and Major Cardiac and Cerebral Events in Patients Undergoing Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suleyman Demirel University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
n-acetyl cysteine, percutaneous coronary intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure
Arm Title
n-acetyl cysteine
Arm Type
Experimental
Arm Description
30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure
Intervention Type
Drug
Intervention Name(s)
N-acetyl cysteine
Intervention Type
Drug
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
periprocedural myocardial infarction
Time Frame
postprocedural 3-6 h
Secondary Outcome Measure Information:
Title
NAC side effects (Asthma exacerbation, pruritus, dyspnea)
Time Frame
during hospitalization at 48 hours
Title
major cardiac and cerebral events
Time Frame
1 year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Suleyman Demirel University
City
Isparta
State/Province
Mediterranean Region
ZIP/Postal Code
32260
Country
Turkey

12. IPD Sharing Statement

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Effects of N-acetyl Cysteine During Percutaneous Coronary Intervention

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