A Trial of INO-1001 in Patients Undergoing Heart Surgery That Involves Heart-lung Bypass

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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
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Heart Diseases, Postoperative Complications

Intervention / Treatment
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* Drug: INO-1001


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: INO-1001|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in serious post-operative complications occurring in the first thirty days after surgery. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, PARP inhibitor, PARP inhibition, Bypass surgery, CPB surgery, Cardiopulmonary bypass, Coronary revascularization, Cardiac valve replacement