Study of ARC1779 in Patients With Acute Myocardial Infarction Undergoing PCI

Acute Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00507338
• Other study ID #: ARC1779-003
• Status: Terminated
• Phase: Phase 2
• First received: July 24, 2007
• Last updated: January 8, 2009
• Start date: October 2007
• Est. completion date: February 2008

Study information

• Verified date: January 2009
• Source: Archemix Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesRussia: Pharmacological Committee, Ministry of HealthPoland: Ministry of HealthAustria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Procedure:
• PCI
early PCI for NSTEMI; primary PCI for STEMI

Locations

Country	Name	City	State
Russian Federation	Archemix Investigational Site	St. Petersburg	Russia

Sponsors (1)

Lead Sponsor	Collaborator
Archemix Corp.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adequacy of reperfusion		48 hours post-PCI	No
Secondary	bleeding		PCI to hospital discharge	Yes