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

NCT06850831 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-02-05

No results posted yet for this study

Summary

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.

Conditions

  • STEMI - ST Elevation Myocardial Infarction (MI)
  • Primary PCI - STEMI

Interventions

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Ahmad Yasa, MD · Universitas Sebelas Maret

  • Trisulo Wasyanto, Prof. DR.dr. · Universitas Sebelas Maret

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-09-01
Completion
2025-12-07

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06850831 on ClinicalTrials.gov