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NCT01848106 · ClinicalTrials.gov registry record · Phase 3
A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI
A Phase 3 study, sponsored by Regado Biosciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 3,232
- Enrollment target
NCT01848106: Clinical Trial Phase 3 study, sponsored by Regado Biosciences.
NCT01848106 is a Phase 3 study that was terminated before completion, run by Regado Biosciences. The registered enrollment target is 3,232 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (319% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01848106, a Phase 3 study, was terminated before completion, sponsored by Regado Biosciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 3,232 participants
- Enrollment target
Study Summary
This study is designed to determine the efficacy of REG1 compared to bivalirudin in preventing periprocedural ischemic complications and major bleeding in patients undergoing PCI as a treatment for CAD. Bivalirudin has been studied in patients undergoing PCI in both ACS (NSTEMI and unstable angina \[UA\]) and elective PCI. In comparison to UFH, bivalirudin has shown similar rates of ischemic events while demonstrating a significant reduction in bleeding and an improved net clinical benefit. Evidence from previous studies indicates that pegnivacogin represents an extremely potent, chemically unique anticoagulant that can be reversed by anivamersen across multiple populations (refer to Section 1.2.2). The question that still remains is whether Factor IX (FIX) inhibition by pegnivacogin can result in fewer ischemic events than a previously studied agent while active control with anivamersen can preserve the benefit of reduced bleeding. The purpose of this study is to evaluate REG1 in an adequately powered definitive study with an open-label, multi-center, active-controlled, randomized design to answer that question.
Primary Outcome
The primary efficacy endpoint is the composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 3.
Interventions
- DRUG Bivalirudin
- DRUG pegnivacogin/anivamersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,232 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-08 |
| Phase | Phase 3 |
Why NCT01848106 stopped before completion
NCT01848106 is an interventional study that assigns participants to a tested intervention. Its 3,232 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (319% higher).
The record links to 0 conditions, and to 2 interventions - of which Bivalirudin is the first listed.
NCT01848106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01848106 about?
NCT01848106 is a clinical study titled "A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI". This study is designed to determine the efficacy of REG1 compared to bivalirudin in preventing periprocedural ischemic complications and major bleeding in patients undergoing PCI as a treatment for CAD. Bivalirudin has been studied in patients undergoing PCI in both ACS (NSTEMI and unstable angina \...
What is the current status of trial NCT01848106?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 3,232 participants. The study started on 2013-09. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01848106?
The interventions under investigation include: Bivalirudin (DRUG), pegnivacogin/anivamersen (DRUG).
Who is sponsoring clinical trial NCT01848106?
This trial is sponsored by Regado Biosciences, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01848106's enrollment target sits among peer trials
3,232 73rd of 2000 higher than 1,928 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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