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

NCT00271167 | Terminated Phase 2

• 1 other identifier: IPC-05-2004
• Study Type: interventional
• Target: 162
• Locations: 4 countries
• Sites: 13

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.

Conditions

Heart Diseases; Postoperative Complications

Keywords

Cardiac surgery; PARP inhibitor; PARP inhibition; Bypass surgery; CPB surgery; Cardiopulmonary bypass; Coronary revascularization; Cardiac valve replacement

Outcome Measures

Primary Outcomes (1)

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

Interventions

INO-1001 DRUG

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo cardiopulmonary bypass for coronary revascularization and/or valve surgery
• Males and non-pregnant, non-lactating females

You may not qualify if:

• 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

Sponsors & Collaborators

• Inotek Pharmaceuticals Corporation: lead

Study Sites (13)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73152, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Unknown Facility

Sydney, New South Wales, Australia

Location

Ashford Cardiac Clinic / Adelaide Cardiac

Adelaide, South Australia, Australia

Location

St. Vincent's Hospital

Melbourne, Victoria, 3065, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Care Hospital

Hyderabad, India

Location

Escorts Heart Institute and Research Centre

New Delhi, 110029, India

Location

Wolfson Medical Centre

Holon, 58100, Israel

Location

Unknown Facility

Jerusalem, Israel

Location

Related Publications (3)

• 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. doi: 10.1016/S1072-7515(03)00538-6.

  PMID: 12892811 BACKGROUND

• Virag L, Szabo C. The therapeutic potential of poly(ADP-ribose) polymerase inhibitors. Pharmacol Rev. 2002 Sep;54(3):375-429. doi: 10.1124/pr.54.3.375.

  PMID: 12223530 BACKGROUND

• Szabo C. Pharmacological inhibition of poly(ADP-ribose) polymerase in cardiovascular disorders: future directions. Curr Vasc Pharmacol. 2005 Jul;3(3):301-3. doi: 10.2174/1570161054368553.

  PMID: 16026326 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Postoperative Complications

Interventions

INO 1001

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 29, 2005
• First Posted: December 30, 2005
• Study Start: October 1, 2005
• Study Completion: June 1, 2006
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

AU (4); IL (2); US (5); IN (2)