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

Phase 2TerminatedNCT00271167

Inotek Pharmaceuticals Corporation162 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

162

Conditions

Heart Diseases Postoperative Complications

Interventions

INO-1001DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (13)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Reduction in serious post-operative complications occurring in the first thirty days after surgery.

Data from ClinicalTrials.gov

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