Heart Diseases Clinical Trial
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.
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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