The purpose of this study is to assess the safety of INO-1001, an intravenous PARP (poly-polymerase) inhibitor, in patients undergoing heart surgery. The study also measures whether INO-1001 reduces the side effects caused by heart-lung bypass machines.
Official Title
A Phase II Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Tolerability, Safety, Pharmacokinetics and Efficacy of Intravenous INO-1001 in High Risk Subjects Undergoing Cardiopulmonary Bypass for Coronary Revascularization and/or Valve Surgery.
Conditions
Heart Diseases, Postoperative Complications
Study Type
Interventional
Study Design
Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Further Details
- Primary Outcome Measures: Reduction in serious post-operative complications occurring in the first thirty days after surgery.
Heart-lung bypass during heart surgery sometimes leads to side effects or complications after surgery.Studies have shown that PARP inhibitors protect cells from damage due to lack of oxygen. Heart-lung bypass during heart surgery can result in cells being deprived of oxygen. INO-1001 may be able to protect these cells and reduce complications following surgery. A total of 162 patients will be randomly assigned to either INO-1001 or placebo (sugar water). Treatment will begin on the day of heart surgery and continue for 36 hours. A total of 4 doses of INO-1001 will be given. Patients will be followed up until 30 days after surgery.
Study Start
October 2005; Study completion: June 2006
Eligibility & Criteria
- Ages Eligible for Study: 18 Years – 90 Years
- Genders Eligible for Study: Both
Inclusion Criteria:
- Patients scheduled to undergo cardiopulmonary bypass for coronary revascularization and/or valve surgery
- Males and non-pregnant, non-lactating females
Exclusion Criteria:
- Subjects will be required to undergo a full medical review in order to exclude serious medical or psychological illness prior to inclusion
- History of a hypersensitivity reaction to more than three drugs or to mannitol
- Participation in any other investigational study within 30 days of the screening phase
- Known alcohol or drug abuse within the last year
- Treatment with certain restricted medications within a specified time prior to participation in the study
Total Enrolment
162
Contact Details
Australian Locations
- Sydney, New South Wales, Australia
- Ashford Cardiac Clinic / Adelaide Cardiac, Adelaide, South Australia, Australia
- St. Vincent’s Hospital, Melbourne, Victoria, 3065, Australia
- Royal Perth Hospital, Perth, Western Australia, 6000, Australia
Publication of Results:
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