A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of the REG1 anticoagulation System in Acute Coronary Syndrome (ACS) patients undergoing cardiac catheterization.

Detailed Description
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Primary Outcome Bleeding Secondary Outcome Ischemia

Official Title
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A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome

Conditions
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Acute Coronary Syndrome (ACS)

Intervention / Treatment
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* Drug: REG1
* Drug: Heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chest pain or other ischemic symptoms a minimum of 10 minutes in duration within 72 hours before anticipated cardiac catheterization; At least one of the following criteria are met: New or presumably new ST-segment depression of at least 1 mm or transient (30 minutes) ST-segment elevation of at least 1 mm in 2 contiguous leads; Elevated troponin I, T, or creatine phosphokinase-MB isoenzyme level within 24 hours of signing consent as defined by the universal MI definition Documented coronary artery disease as evidenced on prior angiography, or by prior angioplasty, bypass graft surgery, or myocardial infarction Exclusion Criteria: Acute ST-segment elevation myocardial infarct Anticipated inability to perform angiography within 24 hours of dosing Evidence of clinical instability Contraindications to anticoagulant use Recent cardiac intervention Clinically abnormal laboratory or test findings during screening Subject is pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: REG1-a<br>Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent) | Drug: REG1<br>* IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention<br>|
| Experimental: REG1-b<br>Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent) | Drug: REG1<br>* IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention<br>|
| Experimental: REG1-c<br>Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent) | Drug: REG1<br>* IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention<br>|
| Experimental: REG1-d<br>Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent) | Drug: REG1<br>* IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention<br>|
| Active Comparator: Heparin<br>Heparin per standard of care at the local institution | Drug: Heparin<br>* IV dose per standard of care at the local institution<br>* Other names: low molecular weight heparin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite incidence of major and minor bleeding |  | Through Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACS, Acute Coronary Syndrome, Catheterization