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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INO-1001 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of INO-1001 will be measured by evaluation of symptoms, vital signs, physical examination, laboratory data, electrocardiograms, etc. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States | ||
| Porter Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11498530 | Background | 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. | |
| 9463632 | Background |
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| Valparaiso |
| Indiana |
| 46383 |
| United States |
| St. Paul Heart Clinic | Saint Paul | Minnesota | 55102 | United States |
| 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 |
| 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 |
| Rehovot | Israel |
| Assaf Harofe Medical Centre | Ẕerifin | Israel |
| Zingarelli 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. |
| 9670921 | Background | Zingarelli 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. |
| 10072736 | Background | Grupp 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. |
| 18535785 | Derived | Morrow 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. |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| C491685 | INO 1001 |
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