Combined Antioxidant Therapy Against Myocardial Reperfusion Injury. Phase I Study.
Status:
Recruiting
Trial end date:
2022-07-31
Target enrollment:
Participant gender:
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, our team has
achieved a reduction of infarct size in an acute myocardial infarction model of isolated rat
heart through a synergistic effect of three compounds in a combined antioxidant therapy
(CAT).
In this study, we 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". Subjects
(18-30 years old, n=18) will be randomized 2:1 to receive CAT or placebo over 60 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 reactions will be registered from the
onset of infusion until day 7.
Phase:
Phase 1
Details
Lead Sponsor:
University of Chile
Collaborator:
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile