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Early Intracoronary N-Acetylcysteine During Primary PCI in STEMI: A Pilot Randomized Trial of Reperfusion Injury Biomarkers and Functional Recovery
Sponsor: dr. Ahmad Yasa, Sp.JP, Subsp.K.I.(K), M.Kes, FIHA, FasCC, FA
Summary
Myocardial ischemia-reperfusion injury still poses a major therapeutic challenge in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). N-acetylcysteine (NAC) is a thiol-containing antioxidant and precursor to glutathione, and may attenuate oxidative stress, inflammatory activation, apoptosis-related signaling and myocardial damage during early reperfusion. However, evidence from clinical trials exploring early intracoronary NAC delivery during PPCI is still limited. We performed a pilot randomised, double-blind, placebo-controlled trial to determine whether early intracoronary N-acetylcysteine (NAC) administration during primary percutaneous coronary intervention (PPCI) reduces biomarker responses to reperfusion injury and is associated with functional recovery in patients with ST elevation myocardial infarction (STEMI). Participants will be randomized to intracoronary NAC or intracoronary placebo in addition to standard PPCI and guideline based STEMI therapy. The main outcome is the change in malondialdehyde (MDA) from baseline to 24 hours after PPCI. Secondary outcomes include changes in high-sensitivity troponin I, interleukin-6 and caspase-3 and global longitudinal strain and metabolic equivalents derived from the six-minute walk test during follow-up.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2025-04-01
Completion Date
2026-04-30
Last Updated
2026-10-02
Healthy Volunteers
No
Interventions
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.
Locations (1)
Dr. Moewardi General Hospital
Surakarta, Central of Java, Indonesia