Status:
TERMINATED
Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass Graft Surgery
Lead Sponsor:
Mallinckrodt
Conditions:
Coronary Artery Bypass Surgery
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 dam...
Detailed Description
This is a phase 2, randomized, double-blind, placebo-controlled, multicenter, dose escalation and dose-expansion, study that will evaluate safety, PK, and POC-efficacy of IK-1001 in subjects undergoin...
Eligibility Criteria
Inclusion
- 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:
- Current or recent smoker (within last 6 months prior to screening)
- Female
- Diabetes mellitus (a history of diabetes, regardless of duration of disease or need for anti-diabetic agents)
- History of non-disabling stroke, TIA, carotid endarterectomy
- Re- CABG (H/O previous CABG surgery, on or off-pump)
- Peripheral artery surgery or angioplasty
- Recent MI (≥ 48 hours and ≤ 6 weeks before surgery, non STEMI and STEMI infarcts as documented in the medical records of the subject)
- History of congestive heart failure (NYHA CHF Class III or IV)
- Renal dysfunction: creatinine clearance ≥ 30mL/min but \< 60mL/min calculated using Crockroft and Gault formula: Creatinine clearance (mL/min) = (140 - age) x weight (kg) (x 0.85 for females) (72 x serum creatinine)
- Asymptomatic stenosis (≥ 50%) in ≥ 1 carotid artery
- Age \> 65 years
Exclusion
- 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)
- Poorly controlled diabetes mellitus (defined as HbA1c \> 9.0%)
- Planned concomitant cardiac valve or other surgery at time of CABG
- Planned use of thiopental during anesthesia for CABG surgery
- All females of child bearing potential (defined as having menses without an alternative medical cause during the last 12 months). Women who are pregnant (defined as a positive serum pregnancy test), breast-feeding or lactating are also excluded.
- Ongoing alcohol or drug abuse
- Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study
- Subject has participated in another investigational drug or device study within 30 days prior to enrollment to the study.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00858936
Start Date
May 1 2009
End Date
April 1 2010
Last Update
October 19 2016
Active Locations (8)
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1
Ashford Hospital
Ashford, South Australia, Australia, 5035
2
Flinder Medical Center
Bedford Park, South Australia, Australia, 5042
3
Austin Hospital
Heidelberg, Victoria, Australia, 3084
4
Alfred Hospital
Melbourne, Victoria, Australia, 3004