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

NCTId: NCT00271167

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.

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.

Eligibility

Eligibility Criteria

Gender Minimum Age Maximum Age Healthy Volunteers?
Both 18 Years 90 Years False

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

Interventions & Outcomes

Study Interventions & Types

Drug Intervention(s)

INO-1001

Study Outcomes

Primary Outcome(s)

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

Facility Locations

Research Study Facility Map

Map of facility locations for this research study.

Facility is recruiting
Facility is not yet recruiting
Unknown status

Clinical Research Study Facility Locations


Jerusalem, Israel

Wolfson Medical Centre
Holon, 58100 Israel

Escorts Heart Institute and Research Centre
New Delhi, 110029 India

Care Hospital
Hyderabad, India

Royal Perth Hospital
Perth, Western Australia 6000 Australia

St. Vincent's Hospital
Melbourne, Victoria 3065 Australia

Ashford Cardiac Clinic / Adelaide Cardiac
Adelaide, South Australia Australia


Sydney, New South Wales Australia

Methodist Hospital
Houston, Texas 77030 United States

Rapid City Regional Hospital
Rapid City, South Dakota United States

University of Pennsylvania
Philadelphia, Pennsylvania 19104 United States

University of Oklahoma
Oklahoma, Oklahoma 73152 United States

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215 United States

Related Keywords & Studies

Conditions and Diseases with Related Research Studies

  1. Heart Diseases
  2. Postoperative Complications

Related Heart Diseases Research

  1. A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients With Dual-Chamber Pacemakers or Defibrillators
  2. A Quality Ensuring Project With Focus On Patients With Cardiovascular Diseases As Well As Type 2 Diabetes.
  3. A Study of the Effect of Blinding in a Trial of Blood Filtration During Heart Surgery
  4. A Trial to Evaluate a New Strategy in the Functional Assessment of 3-vessel Disease Using the SYNTAX II Score in Patients Treated With PCI
  5. Acute Cardiac Ischemia in Women in the ACI/TIPI Trial
  6. Adiposity and Fat Patterning in Black Americans
  7. AIDS-Associated Heart Disease -- Incidence and Etiology
  8. Anaesthetic Management of Women With Heart Disease For Labor and Delivery
  9. Angiotensin-II Blockade in Mitral Regurgitation
  10. APPROPRIATE - Rate Adaptive Pacing Sensor