A Study of INO-1001, an Intravenous PARP (Poly [ADP Ribose] Polymerase) Inhibitor in Acute Heart Attack Patients Undergoing Primary Percutaneous Coronary Intervention

Completed · Phase 2

Conditions studied: Acute Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT00271765

Run by

Inotek Pharmaceuticals Corporation

People needed

40

Starts

2004-01-01

Expected to finish

2006-06-01

Last updated by the study team

2006-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with acute myocardial infarction (as defined in protocol) with onset within 24 hours prior to randomization.
• Scheduled for primary percutaneous coronary intervention within 3 hours of presentation at a hospital participating in this study.
• Males and non-pregnant, non-lactating females.

You may not qualify if…

• 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 mannitol.
• Participation in any investigational study within 30 days of randomization
• Treatment with certain restricted medications within a specified time prior to participation in the study.

Where it is running

• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Porter Hospital — Valparaiso, Indiana, United States
• St. Paul Heart Clinic — Saint Paul, Minnesota, United States
• Study site — Newark, New Jersey, United States
• Toledo Hospital — Toledo, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Black Hills Cardiovascular Research — Rapid City, South Dakota, United States
• Study site — Burlington, Vermont, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States
• West Virginia University — Morgantown, West Virginia, United States
• Rambam Medical Center — Haifa, Israel
• Meir Medical Center — Kfar Saba, Israel
• Hasharon Medical Center — Petah Tikva, Israel
• Rabin Medical Center — Petah Tikva, Israel
• Study site — Rehovot, Israel
• Assaf Harofe Medical Centre — Ẕerifin, Israel

Full record on ClinicalTrials.gov

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