A Study of INO-1001, an Intravenous PARP (Poly [ADP Ribose] Polymerase) Inhibitor in Acute Heart Attack Patients Undergoing Primary Percutaneous Coronary Intervention
The primary purpose of this study is to assess the safety of INO-1001 in subjects who have experienced a heart attack and are to be treated with coronary angioplasty.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
|Official Title:||A Phase II Randomized, Placebo-Controlled, Single-Blind, Multi-Center Dose-Escalation Study to Evaluate Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Administration of INO-1001 in Subjects With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention|
- The safety of INO-1001 will be measured by evaluation of symptoms, vital signs, physical examination, laboratory data, electrocardiograms, etc.
- The effect of INO-1001 on heart muscle damage will be evaluated by blood tests. Other blood tests will measure how INO-1001 is absorbed and removed by the body after exposure to different doses.
|Study Start Date:||January 2004|
|Estimated Study Completion Date:||June 2006|
Currently, heart attacks may be treated with clot-dissolving medicines, coronary angioplasty, or a combination of both. Unblocking of blood flow to the heart following coronary angioplasty can cause side effects such as heart tissue and blood vessel damage, abnormal heart rhythms and death of heart muscle cells.
In animal studies, the PARP enzyme has been shown to be involved in damaging heart muscle after the sudden unblocking of coronary arteries. INO-1001 blocks the PARP enzyme, and so it may reduce heart damage in humans who have had their coronary arteries unblocked after a heart attack.
A total of 40 patients will be selected and randomly assigned to either INO-1001 or placebo (sugar water). One dose only of the drug will be given prior to coronary angioplasty. Patients will be followed until 30 days after surgery.
The following information will be gathered: vital signs, symptoms, 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.
|United States, Florida|
|Holy Cross Hospital|
|Fort Lauderdale, Florida, United States, 33308|
|United States, Indiana|
|Valparaiso, Indiana, United States, 46383|
|United States, Minnesota|
|St. Paul Heart Clinic|
|St. Paul, Minnesota, United States, 55102|
|United States, New Jersey|
|Newark, New Jersey, United States|
|United States, Ohio|
|Toledo, Ohio, United States, 43606|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States|
|United States, South Dakota|
|Black Hills Cardiovascular Research|
|Rapid City, South Dakota, United States, 57701|
|United States, Vermont|
|Burlington, Vermont, United States|
|United States, Virginia|
|Sentara Norfolk General Hospital|
|Norfolk, Virginia, United States|
|United States, West Virginia|
|West Virginia University|
|Morgantown, West Virginia, United States, 26506|
|Rambam Medical Center|
|Haifa, Israel, 31096|
|Meir Medical Center|
|Kfar Saba, Israel, 95847|
|Rabin Medical Center|
|Petach Tikva, Israel, 49100|
|Hasharon Medical Center|
|Petach Tikva, Israel, 49100|
|Assaf Harofe Medical Centre|