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ISRCTN
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ISRCTN01837376
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ClinicalTrials.gov identifier
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NCT00507338
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Public title
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Study of ARC1779 in patients with acute myocardial infarction undergoing percutaneous coronary intervention (PCI) (vITAL-1)
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Scientific title
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A phase 2 study of an aptameric von Willebrand Factor antagonist, ARC1779, in patients with acute myocardial infarction undergoing percutaneous coronary intervention
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Acronym
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vITAL-1
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Serial number at source
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ARC1779-003
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Study hypothesis
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Adjunctive anti-thrombotic therapy for PCI of Acute Myocardial Infarction (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 GP1b 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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Lay summary
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Ethics approval
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Ethics Committee of the Medical University of Vienna and the General Hospital of the City of Vienna. Date of approval: 27 November 2007
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Study design
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Randomized, double-blind (subject, caregiver, investigator, outcomes assessor), active control, parallel assignment, multi-center, safety/efficacy study.
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Countries of recruitment
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Austria, Canada, Germany, Israel, Poland, Russian Federation, United States of America
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Disease/condition/study domain
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Acute myocardial infarction
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Participants - inclusion criteria
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1. Troponin-positive Non-ST-segment Elevation Myocardial Infarction (NSTEMI), with diagnostic symptoms and/or electrocardiogram (ECG) abnormalities present within the preceding 24 hours, and a planned "early invasive" management strategy
2. ST-Segment Elevation Myocardial Infarction (STEMI), with planned primary PCI
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Participants - exclusion criteria
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1. History of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days
2. Received treatment with fibrinolytic or GPIIb/IIIa antagonist drugs within the preceding 72 hours
3. Received anticoagulant therapy with a low molecular weight heparin within the preceding 8 hours
4. Severe hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg) not adequately controlled on antihypertensive therapy
5. Major surgery or trauma within the preceding 6 weeks
6. History of stroke within 30 days or any history of hemorrhagic stroke
7. End-Stage Renal Disease (ESRD) with dependency on renal dialysis
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Anticipated start date
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01/10/2007
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Anticipated end date
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31/10/2008
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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300
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Interventions
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Please note that as of 14/05/2008 this trial was terminated.
Procedure: Primary PCI
Study Drugs: Active control - Abciximab (ReoPro®) labeled regimen for primary PCI. Investigational agent - ARC1779 Injection 0.1 mg/kg, 0.3 mg/kg, or 1.0 mg
Duration: Bolus + 12 hr infusion
Frequency: 1 x treatment
Mode of Administration: Intravenous
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Primary outcome measure(s)
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Adequacy of reperfusion (Time frame: 48 hours post-PCI)
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Secondary outcome measure(s)
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Bleeding (Time frame: PCI to hospital discharge)
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Sources of funding
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Archemix Corp (USA)
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Trial website
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Publications
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Contact name
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Dr
Michael
Gibson
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Address
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350 Longwood Avenue
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City/town
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Boston
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Zip/Postcode
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02115
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Country
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United States of America
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Sponsor
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Archemix Corp (USA)
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Address
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300 3rd Street
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City/town
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Cambridge
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Zip/Postcode
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02142
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Country
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United States of America
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Tel
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+1 617 621 7700
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Email
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jgilbert@archemix.com
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Date applied
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10/01/2008
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Last edited
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08/08/2008
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Date ISRCTN assigned
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28/02/2008
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