TerminatedPhase 2

Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass Graft Surgery

Stopped: Study Terminated - Company decision

Australia6 participantsStarted 2009-05

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Subjects must be 18 to 85 years of age
✓. Subject is scheduled to undergo CABG surgery with cardiopulmonary bypass
✓. Subjects at an increased risk for I/R mediated tissue damage: defined as subjects with ≥ 30% but ≤ 50% ejection fraction (as measured by echocardiography within 14 days of study enrollment) or who fulfill at least two of the following criteria:

Exclusion criteria

✕. Known sulfite allergy or sulphur drug allergy
✕. Subjects who have received treatment for asthma within the past 12 months
✕. Myocardial infarction occurring \< 48 hours prior to surgery
✕. Current cardiogenic shock, acute left ventricular rupture, ventricular septal rupture, or papillary muscle rupture
✕. History of prior disabling stroke
✕. Clinically relevant liver disease (defined as serum transaminases ≥ 3 x upper limit of normal for local laboratory)

What they're measuring

Cardiac Troponin T

Timeframe: Day 1 through Day 4

Trial details

NCT IDNCT00858936

SponsorMallinckrodt

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-04

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