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.
The purpose of this study is to assess the safety of INO-1001, an intravenous PARP (poly-[ADP ribose] polymerase) inhibitor, in patients undergoing heart surgery. The study also measures whether INO-1001 reduces the side effects caused by heart-lung bypass machines.
Heart-lung bypass during heart surgery sometimes leads to side effects or complications
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.
The following information will be collected: symptoms, vital signs, physical examination, blood and urine tests, electrocardiograms, and other information from medical charts.
The information provided in this listing is disclosed solely to comply with regulatory requirements. The drug INO-1001 has not yet been approved for marketing and is only available to patients who participate in a clinical trial and are chosen for the treatment group.
|Gender||Minimum Age||Maximum Age||Healthy Volunteers?|
|Both||18 Years||90 Years||False|
- Patients scheduled to undergo cardiopulmonary bypass for coronary revascularization and/or valve surgery
- Males and non-pregnant, non-lactating females
- 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
Interventions & Outcomes
Study Interventions & Types
Measure: Reduction in serious post-operative complications occurring in the first thirty days after surgery.
Research Study Facility Map
Facility is not yet recruiting
Clinical Research Study Facility Locations
Wolfson Medical Centre
Holon, 58100 Israel
Escorts Heart Institute and Research Centre
New Delhi, 110029 India
Royal Perth Hospital
Perth, Western Australia 6000 Australia
St. Vincent's Hospital
Melbourne, Victoria 3065 Australia
Ashford Cardiac Clinic / Adelaide Cardiac
Adelaide, South Australia Australia
Sydney, New South Wales Australia
Houston, Texas 77030 United States
Rapid City Regional Hospital
Rapid City, South Dakota United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104 United States
University of Oklahoma
Oklahoma, Oklahoma 73152 United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215 United States