At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 640 enrolled
Drug / intervention
REG1 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
In Brief
A Phase 2 clinical trial evaluating REG1 and Heparin for Acute Coronary Syndrome (ACS). Completed, enrolled 640 participants across 43 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Coronary Syndrome (ACS)
CountriesCanada, France, Germany, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedJul 2009
Primary CompletionJan 2011
TodayJul 2026
First PostedJul 3, 2009
Enrollment StartJul 1, 2009
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.0 years ago
Interventions
REG1drug
IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
Heparindrug
IV dose per standard of care at the local institution