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

January 8, 2009 updated by: Archemix Corp.

A Phase 2 Study of an Aptameric Von Willebrand Factor Antagonist, ARC1779, in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Russia
      • St. Petersburg, Russia, Russian Federation, 199106
        • Archemix Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
adequacy of reperfusion
Time Frame: 48 hours post-PCI
48 hours post-PCI

Secondary Outcome Measures

Outcome Measure
Time Frame
bleeding
Time Frame: PCI to hospital discharge
PCI to hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

July 24, 2007

First Submitted That Met QC Criteria

July 24, 2007

First Posted (Estimate)

July 26, 2007

Study Record Updates

Last Update Posted (Estimate)

January 9, 2009

Last Update Submitted That Met QC Criteria

January 8, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARC1779-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myocardial Infarction

Clinical Trials on PCI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe