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COMPLETED
NCT06850831
PHASE2

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

View on ClinicalTrials.gov

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

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.

Locations (1)

Dr. Moewardi General Hospital

Surakarta, Central of Java, Indonesia