A Trial of INO-1001 in Patients Undergoing Heart Surgery That Involves Heart-Lung Bypass - Full Text View

Sponsored by:	Inotek Pharmaceuticals Corporation
Information provided by:	Inotek Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:	NCT00271167

Purpose

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	Intervention	Phase
Heart Diseases Postoperative Complications	Drug: INO-1001	Phase II

MedlinePlus related topics: Heart Diseases Heart Surgery

Drug Information available for: INO 1001

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Inotek Pharmaceuticals Corporation:

Primary Outcome Measures:

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

Estimated Enrollment:	162
Study Start Date:	October 2005
Estimated Study Completion Date:	June 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271167

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Oklahoma
University of Oklahoma
Oklahoma, Oklahoma, United States, 73152
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States
United States, Texas
Methodist Hospital
Houston, Texas, United States, 77030
Australia, New South Wales

Sydney, New South Wales, Australia
Australia, South Australia
Ashford Cardiac Clinic / Adelaide Cardiac
Adelaide, South Australia, Australia
Australia, Victoria
St. Vincent's Hospital
Melbourne, Victoria, Australia, 3065
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
India
Escorts Heart Institute and Research Centre
New Delhi, India, 110029
Care Hospital
Hyderabad, India
Israel
Wolfson Medical Centre
Holon, Israel, 58100

Jerusalem, Israel

Sponsors and Collaborators

Inotek Pharmaceuticals Corporation

More Information

Publications:

Khan TA, Ruel M, Bianchi C, Voisine P, Komjati 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.

Virag L, Szabo C. The therapeutic potential of poly(ADP-ribose) polymerase inhibitors. Pharmacol Rev. 2002 Sep;54(3):375-429. Review.

Szabo C. Pharmacological inhibition of poly(ADP-ribose) polymerase in cardiovascular disorders: future directions. Curr Vasc Pharmacol. 2005 Jul;3(3):301-3. Review.

Study ID Numbers:	IPC-05-2004
Study First Received:	December 29, 2005
Last Updated:	December 11, 2006
ClinicalTrials.gov Identifier:	NCT00271167
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Israel: Ministry of Health; India: Ministry of Health

Keywords provided by Inotek Pharmaceuticals Corporation:

Cardiac surgery
PARP inhibitor
PARP inhibition
Bypass surgery

CPB surgery
Cardiopulmonary bypass
Coronary revascularization
Cardiac valve replacement

Study placed in the following topic categories:

Heart Diseases
Postoperative Complications

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009