Study of ARC1779 in Patients With Acute Myocardial Infarction Undergoing PCI

Phase 2TerminatedNCT00507338

Archemix Corp.300 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

300

Conditions

Acute Myocardial Infarction

Interventions

PCIPROCEDURE

early PCI for NSTEMI; primary PCI for STEMI

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Archemix Investigational Site

Saint Petersburg, Russia, Russia

Outcomes

Primary Outcomes

adequacy of reperfusion

Time frame: 48 hours post-PCI

Secondary Outcomes

bleeding

Time frame: PCI to hospital discharge

Data from ClinicalTrials.gov

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