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

Archemix

Status and phase: Terminated; Phase 2

Conditions: Acute Myocardial Infarction

Treatments: Procedure: PCI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00507338

ARC1779-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 4 patient groups

ARC1779 low dose

Experimental group

Description:

0.1 mg/kg

Treatment:

Procedure: PCI

ARC1779 mid dose

Experimental group

Description:

0.3 mg/kg

Treatment:

Procedure: PCI

ARC1779 high dose

Experimental group

Description:

1.0 mg/kg

Treatment:

Procedure: PCI

abciximab

Active Comparator group

Description:

labeled regimen for primary PCI

Treatment:

Procedure: PCI