It will be conducted in subjects undergoing coronary artery bypass graft (CABG) surgery
Conditions
Interventions
Product Name: Sodium Sulfide for Injection
Product Code: IK-1001
Pharmaceutical Form: Intravenous infusion
CAS Number: 1313-84-4
Current Sponsor code: IK-1001
Other descriptive name: Sodium Sulfide n
Sponsors
Ikaria, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must be 18 to 85 years of age 2. Subject is scheduled to undergo CABG surgery with cardiopulmonary bypass 3. 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 antidiabetic agents) • History of non-disabling stroke, transient ischemic attack (TIA), or carotid endarterectomy • Re-CABG surgery (history of [H/O] previous CABG surgery by any approach, on or off pump) • Peripheral artery surgery or angioplasty • Recent MI (= 48 hours and = 6 weeks before enrollment, non-STEMI and STEMI infarcts as documented in the medical records of the subject) • History of congestive heart failure (CHF) (NYHAssociation CHF Class III or IV) • Renal dysfunction (creatinine clearance = 30mL/min, but 65 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known sulfite allergy or sulphur drug allergy. 2. Myocardial infarction occurring 9.0%) 9. Planned concomitant valve or other surgery 10. All females of child bearing potential as determined by medical history and Principal Investigator evaluation 11. Ongoing alcohol -or drug abuse 12. Any underlying medical or psychiatric condition that, in the opinion of the investigator, makes the subject an unsuitable candidate for the study 13. Subject has participated in another investigational drug or device study within 30 days prior to enrollment to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to evaluate safety, pharmacokinetics (PK) and proof-of-concept (POC) therapeutic efficacy of IK-1001, measured as a reduction (25% compared to placebo) in serum levels of CK-MB and Cradiac Troponin T at 24 hours, and area under concentration-time curve (AUC) at 72 hours post-end of infusion (EOI) when administered intravenously during coronary artery bypass surgery in subjects with coronary artery atherosclerosis who are at an increased risk for ischemia-reperfusion (I/R) mediated cardiac tissued damage.;Secondary Objective: The secondary objectives of this study are to assess the impact of IK-1001 as compared to placebo in subjects undergoing coronary artery bypass graft (CABG) on: 1 Mortality 2. Incidence of nonfatal MI 3. The composite of cardiovascular death, nonfatal MI, nonfatal stroke, and renal insufficiency 4. Incidence of nonfatal stroke 5. Renal insufficiency 6. Incidence of unstable angina 7. Incidence of new atrial fibrillation 8. Change in LV function 9. Need for vasopressor and inotropes during study drug infusion 10.Need for intra-aortic balloon pump (IABP) post surgery 11. Re-admission and subsequent re-intervention for coronary artery disease, (percutaneous coronary intervention 12.Length of intubation 13.Length of stay in cardiac surgery intensive care unit (ICU) or equivalent 14.Length of hospital stay 15.The markers of oxidative stress and inflammation ;Primary end point(s): There are four potential primary endpoints: 1. A 25% reduction in the release of CK-MB in IK-1001 treated subjects compared with placebo treated subjects, measured at 24 hours post EOI. 2. A 25% reduction in the release of CK-MB in IK-1001 treated subjects compared with placebo treated subjects, measured as AUC during 72 hours post EOI. 3. A 25% reduction in the release of Cardiac Troponin T in IK-1001 treated subjects compared with placebo treated subjects, measured at 24 hours p | — |
Countries
Germany
Outcome results
None listed