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

NCT06850831 | Completed Phase 2 DMC

• 1 other identifier: 374/II/HREC/2025
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

STEMI; Primary PCI; Intracoronary NAC; Reperfusion Injury; Apoptosis; Necrosis; Oxidative Stress; Remodelling; Left ventricular dysfunction; Physical Recovery

Outcome Measures

Primary Outcomes (4)

• Improvements in Biomolecular Parameters (Oxidative Stress)

  Malondialdehyde (ng/L)

  24 hours

• Improvements in Biomolecular Parameters (Inflammation)

  Interleukin-6 (ng/L)

  24 hours

• Improvements in Biomolecular Parameters (Necrosis)

  high sensitivity troponin I (ng/L)

  24 hours

• Improvements in Biomolecular Parameters (Apoptosis)

  Caspase-3 (ng/L)

  24 hours

Secondary Outcomes (5)

• Improvements in Echocardiographic Parameters

  1 weeks

• Improvements in Physical Parameters

  1 week

• All-cause mortality

  30-days and 6 months

• Rehospitalization

  30-days and 6 months

• Recurrent ACS events

  30-days and 6 months

Study Arms (2)

Intracoronary NAC

EXPERIMENTAL

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.

Control

PLACEBO COMPARATOR

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

Interventions

Antipac DRUG

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.

Control

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Aged 30-60 years
• Willing to participate in the study and sign informed consent.

You may not qualify if:

• Patients with cardiogenic shock (SBP ≤ 80 mmHg, cold extremities, urine output \<0.5 ml/kg/hour) \<24 hours before randomization
• Patients with a history of myocardial infarction
• Patients with a history of chronic heart failure before the onset of AMI
• Patients scheduled for coronary artery bypass surgery
• Patients with chronic renal failure or requiring dialysis
• Patients with chronic inflammation
• Patients with malignancy
• Patients with a history of hyper/hypothyroidism
• Patients with acute infection
• Patients with sepsis
• Patients with acute stroke
• Patients with pulmonary fibrosis
• Patients with a history of autoimmune disease
• Patients with a history of anti-inflammatory / antioxidant supplementation
• Patients with allergy to N-acetylcysteine

Sponsors & Collaborators

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

Study Sites (1)

Dr. Moewardi General Hospital

Surakarta, Central of Java, 57126, Indonesia

Location

Related Publications (7)

• Liu HW, Han YL, Jin QM, Wang XZ, Ma YY, Wang G, Wang B, Xu K, Li Y, Chen SL. One-year Outcomes in Patients with ST-segment Elevation Myocardial Infarction Caused by Unprotected Left Main Coronary Artery Occlusion Treated by Primary Percutaneous Coronary Intervention. Chin Med J (Engl). 2018 Jun 20;131(12):1412-1419. doi: 10.4103/0366-6999.233948.

  PMID: 29893357 BACKGROUND

• Yang C, Deng Z, Li J, Ren Z, Liu F. Meta-analysis of the relationship between interleukin-6 levels and the prognosis and severity of acute coronary syndrome. Clinics (Sao Paulo). 2021 Jul 5;76:e2690. doi: 10.6061/clinics/2021/e2690. eCollection 2021.

  PMID: 34231707 BACKGROUND

• Aladag N, Asoglu R, Ozdemir M, Asoglu E, Derin AR, Demir C, Demir H. Oxidants and antioxidants in myocardial infarction (MI): Investigation of ischemia modified albumin, malondialdehyde, superoxide dismutase and catalase in individuals diagnosed with ST elevated myocardial infarction (STEMI) and non-STEMI (NSTEMI). J Med Biochem. 2021 Jun 5;40(3):286-294. doi: 10.5937/jomb0-28879.

  PMID: 34177373 BACKGROUND

• Rathod KS, Hamshere S, Khambata RS, Andiapen M, Westwood M, Mathur A, Ahluwalia A, Jones DA. Combined analysis of the safety of intra-coronary drug delivery during primary percutaneous coronary intervention for acute myocardial infarction: A study of three clinical trials. JRSM Cardiovasc Dis. 2017 Aug 16;6:2048004017725988. doi: 10.1177/2048004017725988. eCollection 2017 Jan-Dec.

  PMID: 29104752 BACKGROUND

• Pasupathy S, Tavella R, Grover S, Raman B, Procter NEK, Du YT, Mahadavan G, Stafford I, Heresztyn T, Holmes A, Zeitz C, Arstall M, Selvanayagam J, Horowitz JD, Beltrame JF. Early Use of N-acetylcysteine With Nitrate Therapy in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction Reduces Myocardial Infarct Size (the NACIAM Trial [N-acetylcysteine in Acute Myocardial Infarction]). Circulation. 2017 Sep 5;136(10):894-903. doi: 10.1161/CIRCULATIONAHA.117.027575. Epub 2017 Jun 20.

  PMID: 28634219 BACKGROUND

• Hausenloy DJ, Yellon DM. Myocardial ischemia-reperfusion injury: a neglected therapeutic target. J Clin Invest. 2013 Jan;123(1):92-100. doi: 10.1172/JCI62874. Epub 2013 Jan 2.

  PMID: 23281415 BACKGROUND

• Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.

  PMID: 37622654 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Reperfusion Injury; Necrosis; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Ventricular Dysfunction

Study Officials

• Ahmad Yasa, MD

  Universitas Sebelas Maret

  PRINCIPAL INVESTIGATOR

• Trisulo Wasyanto, Prof. DR.dr.

  Universitas Sebelas Maret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial and Double Blind (Researcher \& Patients)

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: February 27, 2025
• Study Start: April 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 7, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)