Study of ARC1779 in Patients With Acute Myocardial Infarction Undergoing PCI

Phase 2

Terminated

• Conditions: Acute Myocardial Infarction
• Interventions: Procedure: PCI

• Registration Number: NCT00507338
• Lead Sponsor: Archemix Corp.

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 Timeline

• Study First Submitted: 2007-07-24
• Study First Submitted QC: 2007-07-24
• Study First Posted: 2007-07-26
• Study Start: 2007-10
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-08
• Last Update Posted: 2009-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARC1779 low dose	PCI	0.1 mg/kg
ARC1779 mid dose	PCI	0.3 mg/kg
ARC1779 high dose	PCI	1.0 mg/kg
abciximab	PCI	labeled regimen for primary PCI

Primary Outcome Measures

Name	Time	Method
adequacy of reperfusion	48 hours post-PCI

Secondary Outcome Measures

Name	Time	Method
bleeding	PCI to hospital discharge

Trial Locations

Locations (1)

Archemix Investigational Site; 🇷🇺 St. Petersburg, Russia, Russian Federation