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Study of ARC1779 in Patients With Acute Myocardial Infarction Undergoing PCI (vITAL-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00507338
Recruitment Status : Terminated
First Posted : July 26, 2007
Last Update Posted : January 9, 2009
Sponsor:
Information provided by:
Archemix Corp.

Tracking Information
First Submitted Date  ICMJE July 24, 2007
First Posted Date  ICMJE July 26, 2007
Last Update Posted Date January 9, 2009
Study Start Date  ICMJE October 2007
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2007)
adequacy of reperfusion [ Time Frame: 48 hours post-PCI ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2007)
bleeding [ Time Frame: PCI to hospital discharge ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ARC1779 in Patients With Acute Myocardial Infarction Undergoing PCI
Official Title  ICMJE A Phase 2 Study of an Aptameric Von Willebrand Factor Antagonist, ARC1779, in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention
Brief Summary ARC1779 is a novel drug being tested in patients undergoing angioplasty and stenting as their primary treatment for heart attack.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE Procedure: PCI
early PCI for NSTEMI; primary PCI for STEMI
Study Arms  ICMJE
  • Experimental: ARC1779 low dose
    0.1 mg/kg
    Intervention: Procedure: PCI
  • Experimental: ARC1779 mid dose
    0.3 mg/kg
    Intervention: Procedure: PCI
  • Experimental: ARC1779 high dose
    1.0 mg/kg
    Intervention: Procedure: PCI
  • Active Comparator: abciximab
    labeled regimen for primary PCI
    Intervention: Procedure: PCI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: July 24, 2007)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00507338
Other Study ID Numbers  ICMJE ARC1779-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James Gilbert, MD/Chief Medical Officer, Archemix, Corp.
Study Sponsor  ICMJE Archemix Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Michael Gibson, MD Harvard Medical School, Beth Israel Deaconess Medical Center
Principal Investigator: Franz-Josef Neumann, MD Herz-Zentrum Bad Krozingen
PRS Account Archemix Corp.
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP