Combined Antioxidant Therapy for Acute Myocardial Infarction

NCT07776288 | Not Yet Recruiting Phase 2

• 2 other identifiers: Phase 2 - FONDECYT 1211850FONDECYT 1211850
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a combined antioxidant therapy (CAT) can reduce heart damage caused by the return of blood flow after blocked arteries are reopened in adults with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). It will also learn about the safety of this treatment. The main questions it aims to answer are:

• Be randomly assigned to receive either CAT or placebo
• Receive the study infusion before and during primary PCI, in addition to standard treatment for STEMI
• Have blood tests to measure heart injury, oxidative stress, inflammation, and drug levels
• Undergo cardiac magnetic resonance imaging about 3 to 7 days after STEMI.
• Be followed for clinical outcomes and safety for 30 days.

Conditions

Acute Myocardial Infarction (AMI); ST Elevation (STEMI) Myocardial Infarction; Reperfusion Injuries, Myocardial

Keywords

Antioxidant Therapy; Acute Myocardial Infarction; Randomized Controlled Trial; Oxidative stress; Reperfusion Injuries, Myocardial

Outcome Measures

Primary Outcomes (1)

• Infarct Size

  Infarct size by CMR: infarct size will be expressed as a percentage of left ventricular (LV) mass (%LV). Infarct size will be measured using late gadolinium enhancement with manual contouring.

  3-7 days after Primary Coronary Intervention

Secondary Outcomes (7)

• Cardiac Function and structure by CMR

  3-7 days after Primary Percutaneous Coronary Intervention

• Cardiac function by Transthoracic echocardiography

  Before hospital discharge, approximately 3-7 days after Primary Percutaneous Coronary Intervention

• Myocardial Injury Biomarkers

  Samples will be obtained at baseline (prior to infusion), immediately after Primary Percutaneous Coronary Intervention (PCI), and at 12 hours, 24 hours, and 48 hours after PCI.

• Biomarkers of oxidative stress

  Samples will be obtained at baseline (prior to infusion), immediately after Primary Percutaneous Coronary Intervention (PCI), and at 12 hours, 24 hours, and 48 hours after PCI.

• Biomarkers of inflammation

  Samples will be obtained at baseline, 12 hours, and 24 hours after Primary Percutaneous Coronary Intervention.

Study Arms (2)

Combined Antioxidant Therapy

EXPERIMENTAL

Participants receive combined antioxidant therapy consisting of ascorbate, N-acetylcysteine, and deferoxamine, initiated before reperfusion and maintained during primary PCI, in addition to standard-of-care treatment for STEMI.

Drug: Combined antioxidant therapy

Placebo

PLACEBO COMPARATOR

Participants receive matching placebo infusion initiated before reperfusion and maintained during primary PCI, in addition to standard-of-care treatment for STEMI.

Drug: Placebo

Interventions

Combined antioxidant therapy DRUG

Combined Antioxidant Therapy consisting of ascorbate, N-acetylcysteine and deferoxamine

Combined Antioxidant Therapy

Placebo DRUG

Matching placebo infusion administered before reperfusion and during primary PCI.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• First anterior ST-segment elevation myocardial infarction (STEMI)
• Symptom onset within 6 hours before presentation
• Eligible for primary percutaneous coronary intervention (PCI)
• Provision of informed consent by the participant or a legally authorized representative, according to local ethics requirements

You may not qualify if:

• Prior myocardial infarction
• Cardiogenic shock, defined as Society for Cardiovascular Angiography and Interventions (SCAI) shock class D or E.
• Prior thrombolytic therapy for the index event.
• Chronic kidney disease, defined as serum creatinine greater than 1.5 mg/dL or dialysis.
• Liver cirrhosis
• Advanced heart failure, defined as New York Heart Association (NYHA) class III or IV
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Nephrolithiasis
• Life expectancy less than 6 months
• Implanted cardiac device, including pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization device
• Prior coronary artery bypass graft (CABG) surgery
• Pregnancy
• Claustrophobia
• Other contraindications to cardiac magnetic resonance imaging (CMR), according to local protocol

Sponsors & Collaborators

• University of Chile: lead
• Hospital San Juan de Dios,Chile: collaborator

Study Sites (1)

Hospital San Juan de Dios

Santiago, Santiago Metropolitan, 8170000, Chile

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Myocardial Infarction; Myocardial Reperfusion Injury

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cardiomyopathies; Reperfusion Injury; Postoperative Complications

Central Study Contacts

Ramon Rodrigo, Prof.

CONTACT

56 9 994454807; rrodrigo@uchile.cl

Eduardo Villa, MD

CONTACT

56 9 71427205; eduardo.villa.u@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Ramon Rodrigo

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 20, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)