NCT06850831CompletedPhase 2
Early Intracoronary N-Acetylcysteine During Primary PCI in STEMI: A Pilot Randomized Trial of Reperfusion Injury Biomarkers and Functional Recovery
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 110 (actual)
- First submitted
- 23 Feb 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 30 Mar 2026
- Lead sponsor
- dr. Ahmad Yasa, Sp.JP, Subsp.K.I.(K), M.Kes, FIHA, FasCC, FA
- Diseases
- Coronary artery disease
- NCT number
- NCT06850831
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 110
- From 1 Apr 2025 to the primary completion date, 30 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients scheduled for coronary artery bypass surgery
Other illness
- Patients with a history of myocardial infarction
- Patients with a history of chronic heart failure before the onset of AMI
- Patients with chronic renal failure or requiring dialysis
- Patients with malignancy
- Patients with a history of hyper/hypothyroidism
- Patients with acute infection
- Patients with acute stroke
- Patients with a history of autoimmune disease
- Patients with a history of anti-inflammatory / antioxidant supplementation
- Patients with allergy to N-acetylcysteine
Other
- Patients with cardiogenic shock (SBP ≤ 80 mmHg, cold extremities, urine output \<0.5 ml/kg/hour) \<24 hours before randomization
- Patients with chronic inflammation
- Patients with sepsis
- Patients with pulmonary fibrosis
- Pregnant and lactating patients
Who the study is looking for
- 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 18-65 years
- Willing to participate in the study and sign informed consent.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Moewardi General Hospital Coordinator of this site? Confirm its status | Surakarta | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.