Trials / Completed
CompletedNCT00932100
A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 640 (actual)
- Sponsor
- Regado Biosciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | REG1 | IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention |
| DRUG | Heparin | IV dose per standard of care at the local institution |
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2011-01-01
- Completion
- 2011-01-01
- First posted
- 2009-07-03
- Last updated
- 2012-03-02
Locations
43 sites across 4 countries: United States, Canada, France, Germany
Source: ClinicalTrials.gov record NCT00932100. Inclusion in this directory is not an endorsement.