A Study of INO-1001, an Intravenous PARP (Poly [ADP Ribose] Polymerase) Inhibitor in Acute Heart Attack Patients Undergoing Primary Percutaneous Coronary Intervention
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
1 other identifier
interventional
40
2 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2004
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 3, 2006
CompletedFirst Posted
Study publicly available on registry
January 4, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedNovember 29, 2006
November 1, 2006
January 3, 2006
November 27, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The safety of INO-1001 will be measured by evaluation of symptoms, vital signs, physical examination, laboratory data, electrocardiograms, etc.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
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:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Porter Hospital
Valparaiso, Indiana, 46383, United States
St. Paul Heart Clinic
Saint Paul, Minnesota, 55102, United States
Unknown Facility
Newark, New Jersey, United States
Toledo Hospital
Toledo, Ohio, 43606, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Black Hills Cardiovascular Research
Rapid City, South Dakota, 57701, United States
Unknown Facility
Burlington, Vermont, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Rambam Medical Center
Haifa, 31096, Israel
Meir Medical Center
Kfar Saba, 95847, Israel
Hasharon Medical Center
Petah Tikva, 49100, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Unknown Facility
Rehovot, Israel
Assaf Harofe Medical Centre
Ẕerifin, Israel
Related Publications (5)
Liaudet L, Szabo E, Timashpolsky L, Virag L, Cziraki A, Szabo C. Suppression of poly (ADP-ribose) polymerase activation by 3-aminobenzamide in a rat model of myocardial infarction: long-term morphological and functional consequences. Br J Pharmacol. 2001 Aug;133(8):1424-30. doi: 10.1038/sj.bjp.0704185.
PMID: 11498530BACKGROUNDZingarelli B, Cuzzocrea S, Zsengeller Z, Salzman AL, Szabo C. Protection against myocardial ischemia and reperfusion injury by 3-aminobenzamide, an inhibitor of poly (ADP-ribose) synthetase. Cardiovasc Res. 1997 Nov;36(2):205-15. doi: 10.1016/s0008-6363(97)00137-5.
PMID: 9463632BACKGROUNDZingarelli B, Salzman AL, Szabo C. Genetic disruption of poly (ADP-ribose) synthetase inhibits the expression of P-selectin and intercellular adhesion molecule-1 in myocardial ischemia/reperfusion injury. Circ Res. 1998 Jul 13;83(1):85-94. doi: 10.1161/01.res.83.1.85.
PMID: 9670921BACKGROUNDGrupp IL, Jackson TM, Hake P, Grupp G, Szabo C. Protection against hypoxia-reoxygenation in the absence of poly (ADP-ribose) synthetase in isolated working hearts. J Mol Cell Cardiol. 1999 Jan;31(1):297-303. doi: 10.1006/jmcc.1998.0864.
PMID: 10072736BACKGROUNDMorrow DA, Brickman CM, Murphy SA, Baran K, Krakover R, Dauerman H, Kumar S, Slomowitz N, Grip L, McCabe CH, Salzman AL. A randomized, placebo-controlled trial to evaluate the tolerability, safety, pharmacokinetics, and pharmacodynamics of a potent inhibitor of poly(ADP-ribose) polymerase (INO-1001) in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of the TIMI 37 trial. J Thromb Thrombolysis. 2009 May;27(4):359-64. doi: 10.1007/s11239-008-0230-1. Epub 2008 Jun 6.
PMID: 18535785DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 3, 2006
First Posted
January 4, 2006
Study Start
January 1, 2004
Study Completion
June 1, 2006
Last Updated
November 29, 2006
Record last verified: 2006-11