Status:
COMPLETED
A Study of INO-1001, an Intravenous PARP (Poly [ADP Ribose] Polymerase) Inhibitor in Acute Heart Attack Patients Undergoing Primary Percutaneous Coronary Intervention
Lead Sponsor:
Inotek Pharmaceuticals Corporation
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00271765
Start Date
January 1 2004
End Date
June 1 2006
Last Update
November 29 2006
Active Locations (16)
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1
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
2
Porter Hospital
Valparaiso, Indiana, United States, 46383
3
St. Paul Heart Clinic
Saint Paul, Minnesota, United States, 55102
4
Newark, New Jersey, United States