Effect of Intracoronary N-Acetylcysteine in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

February 2, 2026 updated by: dr. Ahmad Yasa, Sp.JP, Subsp.K.I.(K), M.Kes, FIHA, FasCC, FA

Effect of Intracoronary N-Acetylcysteine on Malondialdehyde, Interleukin-6, High Sensitivity Troponin I, Caspase-3, Global Longitudinal Strain, and 6-Minutes Walking Test in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Primary percutaneous coronary intervention (PCI) is the gold standard for reperfusion therapy in patients with ST-elevation myocardial infarction (STEMI), as it restores blood flow by clearing the blocked coronary artery. This process helps reoxygenate the previously hypoxic myocardium, potentially preventing further myocardial cell death. However, despite its benefits, reperfusion therapy, including primary PCI, can also lead to reperfusion injury, which may worsen myocardial damage, increase infarct size, and negatively impact patient outcomes. One of the key contributors to reperfusion injury is reactive oxygen species (ROS), which can induce oncosis, necrosis, and apoptosis, ultimately promoting cell death, myocardial remodeling, left ventricular systolic dysfunction and poorer clinical outcomes. N-Acetylcysteine (NAC), widely known for its mucolytic properties, has also been recognized for its antioxidant and cardioprotective effects. By reducing oxidative stress, NAC has been shown to decrease oncosis, necrosis, and apoptosis, as evidenced by lower levels of malondialdehyde, IL-6, troponin, caspase-3, and major adverse cardiac events in STEMI patients. However, existing research on NAC has only explored oral and intravenous administration. Given that reperfusion injury occurs rapidly, an optimal approach would involve delivering cardioprotective agents directly to the target site, specifically coronary artery endothelial cells. To date, no studies have directly investigated the effects of intracoronary NAC administration in STEMI patients undergoing primary PCI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a double-blind, randomized controlled trial, single-center study in STEMI patients undergoing primary PCI patients held in Moewardi General Hospital, Central Java, Indonesia. The investigator divided 70 patients with STEMI into two groups, the first is the NAC group, which will get 480 mg of intracoronary NAC immediately after the lesion is opened during primary PCI is performed and the second group will have a normal saline bolus. Each patient will be checked for malondialdehyde, IL-6, hs-troponin I, and caspase-3 just before the primary PCI is performed and 24 hours after intervention. GLS examinations were carried out at admission, discharge, and 6 months after the intervention. The 6MWT examinations were conducted at 1 week and 6 months after the intervention. Furthermore, researchers recorded data on all-cause mortality, rehospitalization, and ACS recurrence at day 30 and 6 months. The study was approved by the hospital ethics committee. The clinical parameters above will then be analyzed. To determine the mean difference between each group (intervention and control) before and after treatment a paired T-test is used if the data distribution is normal (if not, the Wilcoxon test is used). To determine the mean difference between unpaired groups (treatment and control), an independent T-test is used if the distribution is normal (if not, the Mann-Whitney test is used). Normality testing is performed using the Shapiro-Wilk test, considering the sample size is less than 50 per group.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Central of Java
      • Surakarta, Central of Java, Indonesia, 57126
        • Dr. Moewardi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. STEMI patients according to The Fourth Universal Definition of Myocardial Infarction from the European Society of Cardiology, American College of Cardiology, American Heart Association, and World Heart Federation Treated by Primary PCI.
  2. Aged 30-60 years
  3. Willing to participate in the study and sign informed consent.

Exclusion Criteria:

  1. Patients with cardiogenic shock (SBP ≤ 80 mmHg, cold extremities, urine output <0.5 ml/kg/hour) <24 hours before randomization
  2. Patients with a history of myocardial infarction
  3. Patients with a history of chronic heart failure before the onset of AMI
  4. Patients scheduled for coronary artery bypass surgery
  5. Patients with chronic renal failure or requiring dialysis
  6. Patients with chronic inflammation
  7. Patients with malignancy
  8. Patients with a history of hyper/hypothyroidism
  9. Patients with acute infection
  10. Patients with sepsis
  11. Patients with acute stroke
  12. Patients with pulmonary fibrosis
  13. Patients with a history of autoimmune disease
  14. Patients with a history of anti-inflammatory / antioxidant supplementation
  15. Patients with allergy to N-acetylcysteine
  16. Pregnant and lactating patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intracoronary NAC
The intervention group will have intracoronary NAC 480 mg immediately after the lesion is opened during primary PCI is performed besides standard treatment of STEMI before further evaluation.
Drug: Antipac
The first group is the NAC group, which will get intracoronary NAC 480 mg immediately after the lesion is opened during primary PCI. And the second group will have placebo immediately after the lesion is opened during primary PCI.
Placebo Comparator: Control
The intervention group will have intracoronary N-AC 480 mg immediately after the lesion is opened during primary PCI besides standard treatment of STEMI before further evaluation.
Drug: Antipac
The first group is the NAC group, which will get intracoronary NAC 480 mg immediately after the lesion is opened during primary PCI. And the second group will have placebo immediately after the lesion is opened during primary PCI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvements in Biomolecular Parameters (Oxidative Stress)
Time Frame: 24 hours
Malondialdehyde (ng/L)
24 hours
Improvements in Biomolecular Parameters (Inflammation)
Time Frame: 24 hours
Interleukin-6 (ng/L)
24 hours
Improvements in Biomolecular Parameters (Necrosis)
Time Frame: 24 hours
high sensitivity troponin I (ng/L)
24 hours
Improvements in Biomolecular Parameters (Apoptosis)
Time Frame: 24 hours
Caspase-3 (ng/L)
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvements in Echocardiographic Parameters
Time Frame: 1 weeks
Global Longitudinal Strain (%)
1 weeks
Improvements in Physical Parameters
Time Frame: 1 week
6 Minutes Walking Test (METs)
1 week
All-cause mortality
Time Frame: 30-days and 6 months
30-days and 6 months
Rehospitalization
Time Frame: 30-days and 6 months
30-days and 6 months
Recurrent ACS events
Time Frame: 30-days and 6 months
30-days and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

dr. Ahmad Yasa, Sp.JP, Subsp.K.I.(K), M.Kes, FIHA, FasCC, FA

Investigators

  • Principal Investigator: Ahmad Yasa, MD, Universitas Sebelas Maret
  • Principal Investigator: Trisulo Wasyanto, Prof. DR.dr., Universitas Sebelas Maret

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

September 1, 2025

Study Completion (Actual)

December 7, 2025

Study Registration Dates

First Submitted

February 23, 2025

First Submitted That Met QC Criteria

February 23, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 374/II/HREC/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study was conducted as part of the final project for doctoral program, there was no sponsorship during this study therefore the IPD cannot be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary PCI - STEMI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe