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

• Sponsor: Inotek Pharmaceuticals Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00271167
• Collaborator: (none)
• Enrollment: 162
• Locations: 13
• Duration (Months): 8
• Patients Per Site: 12.5
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases; Postoperative Complications	Drug: INO-1001	Phase 2

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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.
• Study Start Date: Oct 1, 2005
• Actual Study Completion Date: Jun 1, 2006

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
2	University of Oklahoma	Oklahoma	Oklahoma	United States	73152
3	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
4	Rapid City Regional Hospital	Rapid City	South Dakota	United States
5	Methodist Hospital	Houston	Texas	United States	77030
6		Sydney	New South Wales	Australia
7	Ashford Cardiac Clinic / Adelaide Cardiac	Adelaide	South Australia	Australia
8	St. Vincent's Hospital	Melbourne	Victoria	Australia	3065
9	Royal Perth Hospital	Perth	Western Australia	Australia	6000
10	Care Hospital	Hyderabad		India
11	Escorts Heart Institute and Research Centre	New Delhi		India	110029
12	Wolfson Medical Centre	Holon		Israel	58100
13		Jerusalem		Israel

Sponsors and Collaborators

• Inotek Pharmaceuticals Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Khan TA, Ruel M, Bianchi C, Voisine P, Komjáti K, Szabo C, Sellke FW. Poly(ADP-ribose) polymerase inhibition improves postischemic myocardial function after cardioplegia-cardiopulmonary bypass. J Am Coll Surg. 2003 Aug;197(2):270-7.
• Szabó C. Pharmacological inhibition of poly(ADP-ribose) polymerase in cardiovascular disorders: future directions. Curr Vasc Pharmacol. 2005 Jul;3(3):301-3. Review.
• Virág L, Szabó C. The therapeutic potential of poly(ADP-ribose) polymerase inhibitors. Pharmacol Rev. 2002 Sep;54(3):375-429. Review.

• ClinicalTrials.gov Identifier: NCT00271167
• Other Study ID Numbers: IPC-05-2004
• First Posted: Dec 30, 2005
• Last Update Posted: Mar 25, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by , ,: Cardiac surgery; PARP inhibitor; PARP inhibition; Bypass surgery; CPB surgery; Cardiopulmonary bypass; Coronary revascularization; Cardiac valve replacement
• Additional relevant MeSH terms: Heart Diseases; Postoperative Complications

Study Results

No Results Posted as of Mar 25, 2015