Study of ARC1779 in Patients With Acute Myocardial Infarction Undergoing PCI

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

Detailed Description
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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.

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

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Procedure: PCI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARC1779 low dose<br>0.1 mg/kg | Procedure: PCI<br>* early PCI for NSTEMI; primary PCI for STEMI<br>|
| Experimental: ARC1779 mid dose<br>0.3 mg/kg | Procedure: PCI<br>* early PCI for NSTEMI; primary PCI for STEMI<br>|
| Experimental: ARC1779 high dose<br>1.0 mg/kg | Procedure: PCI<br>* early PCI for NSTEMI; primary PCI for STEMI<br>|
| Active Comparator: abciximab<br>labeled regimen for primary PCI | Procedure: PCI<br>* early PCI for NSTEMI; primary PCI for STEMI<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding |  | PCI to hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous coronary intervention