MedTrace Logo

Combined Antioxidant Therapy Against Myocardial Reperfusion Injury. Phase I Study.

NCT05215743 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-01-12

No results posted yet for this study

Summary

Background: Acute myocardial infarction (AMI) has remained a leading cause of mortality and disability worldwide. Although percutaneous coronary angioplasty (PCA) is the best treatment for these patients, paradoxically this procedure causes reperfusion injury. Considerable efforts aimed to reduce this damage have been made, but the results are disappointing and there is still no effective therapy for preventing the damage. Previously, the investigators have achieved a reduction of infarct size in an experimental model of an isolated rat heart, through a synergistic effect of three compounds in a "combined antioxidant therapy" (CAT).

In this study, the investigators aim to describe the pharmacokinetics and safety of CAT intravenously administered to healthy subjects. This is the first step to a later clinical application of CAT in AMI patients.

Methodology: The safety and pharmacokinetics of the CAT (deferoxamine, N-acetylcysteine, and ascorbate) will be assessed in healthy volunteers in a "phase I clinical trial". Two different formulations (mass of CAT components by bag) with different infusion rates each one will be tested (CAT1 and CAT2). Subjects (18-35 years old, n=18) will be randomized 1:2 to receive a placebo or CAT for 90 minutes. Blood concentrations of each CAT component will be measured in plasma at 0, 15, 30, 60, 90, 120, and 180 minutes after the infusion onset. Adverse events will be registered from the onset of infusion until day 30.

Conditions

  • Acute Myocardial Infarction
  • Ischemia-reperfusion Injury
  • Reperfusion Injury, Myocardial
  • Reperfusion Arrhythmias
  • Reperfusion Injury

Interventions

DRUG

Antioxidant therapy

Active therapy

DRUG

NaCl 0.9%

Placebo

Sponsors & Collaborators

  • Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

    collaborator OTHER_GOV

  • University of Chile

    lead OTHER

Principal Investigators

  • Ramón Rodrigo, Prof. · Program of Pharmacology, ICBM, Faculty of Medicine, University of Chile

  • Abraham IJ Gajardo, MD, PhD · Intensive Care Unit, Hospital Clínico Universidad de Chile

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-09
Primary Completion
2022-11-22
Completion
2022-12-22

Countries

  • Chile

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05215743 on ClinicalTrials.gov