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ARC1779 is a novel drug being tested in patients undergoing angioplasty and stenting as their primary treatment for heart attack.
Adjunctive anti-thrombotic therapy for PCI of AMI may be improved by incorporation of a novel anti-platelet therapeutic principle, von Willebrand Factor antagonism. ARC1779 is a therapeutic oligonucleotide ("aptamer") which blocks the binding of the A1 domain of vWF to the platelet GPIb receptor, and thereby modulates platelet adhesion, activation, and aggregation under the high shear conditions of coronary arterial stenosis and plaque rupture. This study is intended to provide dose-ranging and clinical proof of concept for ARC1779 in a primary PCI population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARC1779 low dose | Experimental | 0.1 mg/kg |
|
| ARC1779 mid dose | Experimental | 0.3 mg/kg |
|
| ARC1779 high dose | Experimental | 1.0 mg/kg |
|
| abciximab | Active Comparator | labeled regimen for primary PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI | Procedure | early PCI for NSTEMI; primary PCI for STEMI |
|
| Measure | Description | Time Frame |
|---|---|---|
| adequacy of reperfusion | 48 hours post-PCI |
| Measure | Description | Time Frame |
|---|---|---|
| bleeding | PCI to hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Gibson, MD | Harvard Medical School, Beth Israel Deaconess Medical Center | Study Chair |
| Franz-Josef Neumann, MD | Herz-Zentrum Bad Krozingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Archemix Investigational Site | Saint Petersburg | Russia | 199106 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30957581 | Derived | Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. |
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