Study of ARC1779 in Patients With Acute Myocardial Infarction Undergoing PCI
vITAL-1
A Phase 2 Study of an Aptameric Von Willebrand Factor Antagonist, ARC1779, in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention
1 other identifier
interventional
300
1 country
1
Brief Summary
ARC1779 is a novel drug being tested in patients undergoing angioplasty and stenting as their primary treatment for heart attack.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2007
CompletedFirst Posted
Study publicly available on registry
July 26, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedJanuary 9, 2009
January 1, 2009
4 months
July 24, 2007
January 8, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
adequacy of reperfusion
48 hours post-PCI
Secondary Outcomes (1)
bleeding
PCI to hospital discharge
Study Arms (4)
ARC1779 low dose
EXPERIMENTAL0.1 mg/kg
ARC1779 mid dose
EXPERIMENTAL0.3 mg/kg
ARC1779 high dose
EXPERIMENTAL1.0 mg/kg
abciximab
ACTIVE COMPARATORlabeled regimen for primary PCI
Interventions
early PCI for NSTEMI; primary PCI for STEMI
Eligibility Criteria
You may qualify if:
- troponin-positive NSTEMI, with diagnostic symptoms and/or ECG abnormalities present within the preceding 24 hours, and a planned "early invasive" management strategy
- STEMI, with planned primary PCI
You may not qualify if:
- History of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Archemix Corp.lead
Study Sites (1)
Archemix Investigational Site
Saint Petersburg, Russia, 199106, Russia
Related Publications (1)
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.
PMID: 30957581DERIVED
Study Officials
- STUDY CHAIR
Michael Gibson, MD
Harvard Medical School, Beth Israel Deaconess Medical Center
- PRINCIPAL INVESTIGATOR
Franz-Josef Neumann, MD
Herz-Zentrum Bad Krozingen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 24, 2007
First Posted
July 26, 2007
Study Start
October 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
January 9, 2009
Record last verified: 2009-01