Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass Graft Surgery
Status:
Terminated
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
This clinical trial will investigate the safety and effectiveness of IK-1001 (the liquid form
of sodium sulfide) when used in Coronary Artery Bypass Graft (CABG) patients to potentially
reduce the damage done to the heart during surgery.
This study has 2 parts. Part 1 will first test 36 subjects at different doses (amount) of the
study drug. There will be 6 different groups of 6 subjects each that will receive the study
drug or a placebo. A placebo is a substance that will be prepared to look like the study drug
but will contain no active ingredients. In Part 1, five subjects from each group will receive
study drug (IK-1001) and one will receive a placebo. This first part of this study is also a
dose (amount) escalation. This means that each group will be receiving a different dose of
the study drug. The first group will receive the lowest dose, the second group will receive a
slightly higher dose, and the third group a slightly higher dose until all six groups has
been tested. You can not choose which group you will be in but prior to starting each new
dose level, the data (information) from the previous dose level will have been reviewed by a
group of qualified individuals to determine if it is safe to proceed to the next highest dose
level.
Part 2 will expand the study and will treat at least 158 (and up to 632) more subjects at a
dose level that has been deemed safe from information collected from Part 1. Subjects in Part
2 of the study will have a 1 in 2 (50%) chance of receiving the study drug or placebo.
Whether the subject gets study drug or the placebo will be randomly assigned (like the toss
of a coin).
The study drug or placebo will be given as an intravenous infusion (into the vein) for six
hours while the subject is having their CABG surgery.
The subjects will be followed up for 6 months after their CABG surgery.