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

• Sponsor: Suleyman Demirel University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01878669
• Collaborator: (none)
• Enrollment: 390
• Location: 1
• Arms: 2
• Duration (Months): 118
• Patients Per Site Per Month: 3.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: N-acetyl cysteine; Drug: Saline	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 390 participants
• 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
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Sep 1, 2017
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. periprocedural myocardial infarction [postprocedural 3-6 h]

Secondary Outcome Measures

1. NAC side effects (Asthma exacerbation, pruritus, dyspnea) [during hospitalization at 48 hours]

2. major cardiac and cerebral events [1 year follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Suleyman Demirel University	Isparta	Mediterranean Region	Turkey	32260

Sponsors and Collaborators

• Suleyman Demirel University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mehmet Ozaydin, MD, MD, Professor, Suleyman Demirel University
• ClinicalTrials.gov Identifier: NCT01878669
• Other Study ID Numbers: ozaydin289
• First Posted: Jun 17, 2013
• Last Update Posted: Jan 11, 2022
• Last Verified: Jan 1, 2022

• Keywords provided by Mehmet Ozaydin, MD, MD, Professor, Suleyman Demirel University: n-acetyl cysteine; percutaneous coronary intervention
• Additional relevant MeSH terms: Coronary Artery Disease; Acetylcysteine; N-monoacetylcystine

Study Results

No Results Posted as of Jan 11, 2022