A Trial of INO-1001 in Patients Undergoing Heart Surgery That Involves Heart-lung Bypass
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|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.|
- Reduction in serious post-operative complications occurring in the first thirty days after surgery.
|Study Start Date:||October 2005|
|Study Completion Date:||June 2006|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271167
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Oklahoma|
|University of Oklahoma|
|Oklahoma, Oklahoma, United States, 73152|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, South Dakota|
|Rapid City Regional Hospital|
|Rapid City, South Dakota, United States|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Australia, New South Wales|
|Sydney, New South Wales, Australia|
|Australia, South Australia|
|Ashford Cardiac Clinic / Adelaide Cardiac|
|Adelaide, South Australia, Australia|
|St. Vincent's Hospital|
|Melbourne, Victoria, Australia, 3065|
|Australia, Western Australia|
|Royal Perth Hospital|
|Perth, Western Australia, Australia, 6000|
|Escorts Heart Institute and Research Centre|
|New Delhi, India, 110029|
|Wolfson Medical Centre|
|Holon, Israel, 58100|