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

Primary Purpose

Acute Myocardial Infarction

Status
Terminated
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
PCI
Sponsored by
Archemix Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring percutaneous coronary intervention

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Archemix Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

ARC1779 low dose

ARC1779 mid dose

ARC1779 high dose

abciximab

Arm Description

0.1 mg/kg

0.3 mg/kg

1.0 mg/kg

labeled regimen for primary PCI

Outcomes

Primary Outcome Measures

adequacy of reperfusion

Secondary Outcome Measures

bleeding

Full Information

First Posted
July 24, 2007
Last Updated
January 8, 2009
Sponsor
Archemix Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT00507338
Brief Title
Study of ARC1779 in Patients With Acute Myocardial Infarction Undergoing PCI
Acronym
vITAL-1
Official Title
A Phase 2 Study of an Aptameric Von Willebrand Factor Antagonist, ARC1779, in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Terminated
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Archemix Corp.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
percutaneous coronary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARC1779 low dose
Arm Type
Experimental
Arm Description
0.1 mg/kg
Arm Title
ARC1779 mid dose
Arm Type
Experimental
Arm Description
0.3 mg/kg
Arm Title
ARC1779 high dose
Arm Type
Experimental
Arm Description
1.0 mg/kg
Arm Title
abciximab
Arm Type
Active Comparator
Arm Description
labeled regimen for primary PCI
Intervention Type
Procedure
Intervention Name(s)
PCI
Intervention Description
early PCI for NSTEMI; primary PCI for STEMI
Primary Outcome Measure Information:
Title
adequacy of reperfusion
Time Frame
48 hours post-PCI
Secondary Outcome Measure Information:
Title
bleeding
Time Frame
PCI to hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gibson, MD
Organizational Affiliation
Harvard Medical School, Beth Israel Deaconess Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Franz-Josef Neumann, MD
Organizational Affiliation
Herz-Zentrum Bad Krozingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Archemix Investigational Site
City
St. Petersburg
State/Province
Russia
ZIP/Postal Code
199106
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
30957581
Citation
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.
Results Reference
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Study of ARC1779 in Patients With Acute Myocardial Infarction Undergoing PCI

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