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

This study has been terminated.
Sponsor:
Information provided by:
Archemix Corp.
ClinicalTrials.gov Identifier:
NCT00507338
First received: July 24, 2007
Last updated: January 8, 2009
Last verified: January 2009
  Purpose

ARC1779 is a novel drug being tested in patients undergoing angioplasty and stenting as their primary treatment for heart attack.


Condition Intervention Phase
Acute Myocardial Infarction
Procedure: PCI
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of an Aptameric Von Willebrand Factor Antagonist, ARC1779, in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by Archemix Corp.:

Primary Outcome Measures:
  • adequacy of reperfusion [ Time Frame: 48 hours post-PCI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • bleeding [ Time Frame: PCI to hospital discharge ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: October 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARC1779 low dose
0.1 mg/kg
Procedure: PCI
early PCI for NSTEMI; primary PCI for STEMI
Experimental: ARC1779 mid dose
0.3 mg/kg
Procedure: PCI
early PCI for NSTEMI; primary PCI for STEMI
Experimental: ARC1779 high dose
1.0 mg/kg
Procedure: PCI
early PCI for NSTEMI; primary PCI for STEMI
Active Comparator: abciximab
labeled regimen for primary PCI
Procedure: PCI
early PCI for NSTEMI; primary PCI for STEMI

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507338

Locations
Russian Federation
Archemix Investigational Site
St. Petersburg, Russia, Russian Federation, 199106
Sponsors and Collaborators
Archemix Corp.
Investigators
Study Chair: Michael Gibson, MD Harvard Medical School, Beth Israel Deaconess Medical Center
Principal Investigator: Franz-Josef Neumann, MD Herz-Zentrum Bad Krozingen
  More Information

No publications provided

Responsible Party: James Gilbert, MD/Chief Medical Officer, Archemix, Corp.
ClinicalTrials.gov Identifier: NCT00507338     History of Changes
Other Study ID Numbers: ARC1779-003
Study First Received: July 24, 2007
Last Updated: January 8, 2009
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Russia: Pharmacological Committee, Ministry of Health
Poland: Ministry of Health
Austria: Agency for Health and Food Safety

Keywords provided by Archemix Corp.:
percutaneous coronary intervention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014