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

Phase 2

Terminated

• Conditions: Heart Diseases; Postoperative Complications

• Registration Number: NCT00271167
• Lead Sponsor: Inotek Pharmaceuticals Corporation

Brief Summary

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

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 Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-12-29
• Study First Submitted QC: 2005-12-29
• Study First Posted: 2005-12-30
• Study Completion: 2006-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (11)

University of Oklahoma; 🇺🇸 Oklahoma, Oklahoma, United States

Royal Perth Hospital; 🇦🇺 Perth, Western Australia, Australia

St. Vincent's Hospital; 🇦🇺 Melbourne, Victoria, Australia

Care Hospital; 🇮🇳 Hyderabad, India

Methodist Hospital; 🇺🇸 Houston, Texas, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Rapid City Regional Hospital; 🇺🇸 Rapid City, South Dakota, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Ashford Cardiac Clinic / Adelaide Cardiac; 🇦🇺 Adelaide, South Australia, Australia

Escorts Heart Institute and Research Centre; 🇮🇳 New Delhi, India

Wolfson Medical Centre; 🇮🇱 Holon, Israel