Acute Coronary Syndrome (ACS)
Conditions
Keywords
ACS, Acute Coronary Syndrome, Catheterization
Brief summary
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
Primary Outcome Bleeding Secondary Outcome Ischemia
Interventions
DRUGREG1
IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
DRUGHeparin
IV dose per standard of care at the local institution
Sponsors
Regado Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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: 1. 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; 2. Elevated troponin I, T, or creatine phosphokinase-MB isoenzyme level within 24 hours of signing consent as defined by the universal MI definition 3. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite incidence of major and minor bleeding | Through Day 30 |
Countries
Canada, France, Germany, United States
Outcome results
None listed