Study of ARC1779 in Patients With Acute Myocardial Infarction Undergoing PCI
NCT ID: NCT00507338
Last Updated: 2009-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
300 participants
INTERVENTIONAL
2007-10-31
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ARC1779 low dose
0.1 mg/kg
PCI
early PCI for NSTEMI; primary PCI for STEMI
ARC1779 mid dose
0.3 mg/kg
PCI
early PCI for NSTEMI; primary PCI for STEMI
ARC1779 high dose
1.0 mg/kg
PCI
early PCI for NSTEMI; primary PCI for STEMI
abciximab
labeled regimen for primary PCI
PCI
early PCI for NSTEMI; primary PCI for STEMI
Interventions
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PCI
early PCI for NSTEMI; primary PCI for STEMI
Eligibility Criteria
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Inclusion Criteria
* STEMI, with planned primary PCI
Exclusion Criteria
* Received treatment with fibrinolytic or GPIIb/IIIa antagonist drugs within the preceding 72 hours
* Received anticoagulant therapy with a low molecular weight heparin within the preceding 8 hours
* Severe hypertension (systolic blood pressure \>200 mmHg or diastolic blood pressure \>110 mmHg) not adequately controlled on antihypertensive therapy
* Major surgery or trauma within the preceding 6 weeks
* History of stroke within 30 days or any history of hemorrhagic stroke
* End-stage renal disease (ESRD) with dependency on renal dialysis
18 Years
75 Years
ALL
No
Sponsors
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Archemix Corp.
INDUSTRY
Responsible Party
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Archemix, Corp.
Principal Investigators
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Michael Gibson, MD
Role: STUDY_CHAIR
Harvard Medical School, Beth Israel Deaconess Medical Center
Franz-Josef Neumann, MD
Role: PRINCIPAL_INVESTIGATOR
Herz-Zentrum Bad Krozingen
Locations
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Archemix Investigational Site
Saint Petersburg, Russia, Russia
Countries
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References
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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.
Other Identifiers
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ARC1779-003
Identifier Type: -
Identifier Source: org_study_id
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