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Third dose group not recruited due to slow enrollment.
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Males and females aged 18-80 years who present with ACS (unstable angina and non ST-elevation MI) defined as one or more episodes of angina lasting at least 5 minutes in the last 24 hours before admission and greater than 0.05 mV of presumed new ST-segment depression in at least 2 contiguous ECG leads OR, angina and per confirmatory angiogram, has been scheduled for percutaneous coronary angioplasty. The primary objective of this study is to evaluate the safety of Serp-1 injection when administered in 3 daily doses to patients undergoing conventional therapy for Acute Coronary Syndrome (ACS) requiring early intervention.
A total of 72 subjects will be enrolled, separated into 3 dose groups and centrally randomized in a 3:1 ratio of Serp-1 injection to placebo control.Subjects will receive Serp-1 by intravenous (IV) bolus injection daily for 3 days, at dose levels of 5.0, 15, and 50 ug/kg/dose or placebo (0.9% normal saline) added to any prescribed therapy for ACS. Serp-1 will be administered as a single IV bolus injection. The initial IV bolus dose is administered immediately preceding the PCI procedure with subsequent doses administered 24 and 48 hours later.Subjects will be evaluated for adverse events, serum inflammatory markers and restenosis rates at 6 months post-dose.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serine proteinase-1 (Serp-1) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Adverse events collected until 6 months post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory marker analysis | ||
| MACE | ||
| Restenosis at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Lucas, MD | Chief Clinical Officer- Viron Therapeutics | Study Director |
| Jean-Claude Tardif, MD | Director- Montreal Heart Institute Research Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| University of Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21062996 | Derived | Tardif JC, L'Allier PL, Gregoire J, Ibrahim R, McFadden G, Kostuk W, Knudtson M, Labinaz M, Waksman R, Pepine CJ, Macaulay C, Guertin MC, Lucas A. A randomized controlled, phase 2 trial of the viral serpin Serp-1 in patients with acute coronary syndromes undergoing percutaneous coronary intervention. Circ Cardiovasc Interv. 2010 Dec;3(6):543-8. doi: 10.1161/CIRCINTERVENTIONS.110.953885. Epub 2010 Nov 9. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 9, 2011 | |
| Reset | Jul 7, 2011 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 9, 2011 | Jul 7, 2011 |
| ID | Term |
|---|---|
| D000789 | Angina, Unstable |
| D003324 | Coronary Artery Disease |
| D023903 | Coronary Restenosis |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Gainesville |
| Florida |
| 32610-0277 |
| United States |
| Spectrum Health | Grand Rapids | Michigan | 49525 | United States |
| Victoria Heart Institute | Vicotria | British Columbia | V8R 4R2 | Canada |
| Foothills Medical Center | Calgary | Ontario | T2N 2T9 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5C1 | Canada |
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D023921 | Coronary Stenosis |