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Active, Not Recruiting

NCT Number: NCT01878344

Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention

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

In a sub-group of patients coronary flow reserve will be evaluated.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acute ST Segment Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Suleyman Demirel University

Isparta, Mediterranean Region, 32260, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Acute ST Elevation Myocardial Infarction undergoing Primary Percutaneous Coronary intervention Who Have Moderate to High Risk For Contrast Induced Nephropathy (Mehran Score ≥5)

Exclusion criteria

  • Patients >18 years old with moderate to high risk for contrast induced nephropathy undergoing 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
  • Allergy to NAC
  • History of Asthma
  • Chronic nitrate usage
  • Malignancy
  • Use of corticosteroids
  • Leucocytosis,Thrombocytosis,Anemia
  • Blood pressure of >180/100mmHg despite anti-hypertensive therapy

Treatment and study plan

NAC

Drug

Saline

Drug

Primary outcomes

  1. Major cardiac and cerebral events

    Time frame: 1 year

Secondary outcomes

  1. NAC side effects (Asthma exacerbation, Pruritus, Dyspnea)

    Time frame: during hospitalization at 48 hours

Sponsors and collaborators

Lead sponsor

Suleyman Demirel University

Other

Registry information

Official study title

Effects of N-acetyl Cysteine on Major Cardiac and Cerebral Events in Patients Undergoing Primary Percutaneous Coronary Intervention Who Have Moderate to High Risk For Contrast Induced Nephropathy

Acronym: EASE-PRM-PCI

Important dates

Study start
2013
Primary completion
2018
Study completion
2026
First posted
Jun 14, 2013
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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