Table of Contents
Trial overview
The available clinical trial data for Sodium Iodide describe one interventional study in patients with anterior ST-elevation myocardial infarction (STEMI), which is a serious type of heart attack.[1] The study was a phase 3 trial and was completed after enrolling 2,351 participants.[1]
The trial title describes a randomized, double-blind, placebo-controlled, multicenter study of IV FDY-5301 in patients with myocardial infarction (STEMI).[1] The brief summary says the study aimed to assess the effect of FDY-5301 on cardiovascular mortality and heart failure events in subjects with an anterior STEMI undergoing pPCI.[1]
Who participated
The target population was patients with anterior ST-elevation myocardial infarction.[1] This means the trial focused on people having a severe heart attack affecting the front part of the heart.[1]
The study specifically included subjects undergoing primary percutaneous coronary intervention (pPCI), which is an emergency procedure used to open a blocked heart artery.[1] This tells patients that the trial was not a general heart study, but one focused on urgent treatment after a major heart attack.[1]
Study design and phase
This was an interventional study, meaning the researchers gave a study treatment and compared outcomes between groups.[1] The design was randomized, double-blind, and placebo-controlled.[1]
Randomized means participants were assigned by chance to study groups.[1] Double-blind means neither the participants nor the study team knew who received the active treatment or the placebo during the study.[1] Placebo-controlled means the treatment was compared with a look-alike product that did not contain the active study medicine.[1]
The study was multicenter, so it was carried out at more than one site.[1] The intervention list names SODIUM IODIDE as an intravenous study drug and also describes a placebo product made to visually match the active injection.[1]
What the trial measured
The main endpoint was the proportion of subjects who had either cardiovascular mortality or a heart failure event through Month 12.[1] An endpoint is the main result the researchers use to judge the study.[1]
Cardiovascular mortality in this study included deaths from sudden presumed arrhythmia, thromboembolic cerebral vascular accident, pulmonary embolism, cardiac rupture, heart failure, recurrent myocardial infarction, or deaths due to procedures used to treat these events.[1] This is a broad measure of serious heart-related death after a heart attack.[1]
The study also tracked heart failure, which means the heart does not pump blood as well as it should.[1] Measuring these outcomes through Month 12 helps researchers see whether the treatment changes important long-term recovery results after STEMI.[1]
Key patient terms
Enrollment means the number of people who joined the trial, which was 2,351 in this study.[1] Completed means the study finished and the planned data collection was done.[1]
Intravenous use means the study treatment was given through a vein.[1] The trial data also show that the placebo was made to match a standard saline solution with Sodium Chloride and Water for Injection, so it looked similar to the active injection.[1]
