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A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI (Regulate)

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ClinicalTrials.gov Identifier: NCT01848106
Recruitment Status : Terminated (Clinical Hold)
First Posted : May 7, 2013
Last Update Posted : October 23, 2014
Sponsor:
Collaborators:
The Cleveland Clinic
Duke Clinical Research Institute
Canadian VIGOUR Centre
Icahn School of Medicine at Mount Sinai
Parexel
Information provided by (Responsible Party):
Regado Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE May 2, 2013
First Posted Date  ICMJE May 7, 2013
Last Update Posted Date October 23, 2014
Study Start Date  ICMJE September 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2013)
Ischemic composite [ Time Frame: Day 3 ]
The primary efficacy endpoint is the composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 3.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI
Official Title  ICMJE A Randomized, Open-Label, Multi-Center, Active-Controlled, Parallel Group Study To Determine the Efficacy and Safety of the REG1 Anticoagulation System Compared to Bivalirudin in Patients Undergoing Percutaneous Coronary Intervention
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: pegnivacogin/anivamersen
    Other Name: Reg 1 Anticoagulation System
  • Drug: Bivalirudin
    Other Name: Angiox, Angiomax
Study Arms  ICMJE
  • Active Comparator: Bivalirudin
    Bivalirudin bolus and infusion
    Intervention: Drug: Bivalirudin
  • Experimental: Reg 1 (pegnivacogin/anivamersen)
    Bolus pegnivacogin plus anivamersen active control agent
    Intervention: Drug: pegnivacogin/anivamersen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 22, 2014)
3232
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2013)
13200
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The study population will consist of patients with CAD undergoing PCI. Three key subgroups will be included
  2. Willing and able to sign an Institutional Review Board/Ethics Committee (IRB/EC) approved informed consent prior to any study-related activities;
  3. Male or female age 18 or greater;
  4. If female of childbearing potential, must have a negative urine or serum pregnancy test or be post-menopausal for at least 1 year prior to randomization. Females of childbearing potential must be practicing adequate birth control to be eligible. It is the Investigator's responsibility for determining whether the patient has adequate birth control for study participation;
  5. Subject is able and willing to comply with the protocol and all study procedures

Exclusion Criteria:

  1. Acute ST-segment elevation myocardial infarction within 48 hours of randomization;
  2. Evidence of current clinical instability
  3. Evidence of a contraindication to anticoagulation or increased risk of bleeding
  4. Use of any investigational drug or device within 30 days of randomization or the planned use of an investigational drug or device through EOS (Day 30 follow-up);
  5. Use of the select antithrombotic agents
  6. Baseline hemoglobin (Hgb) <9 g/dL or equivalent;
  7. Baseline estimated glomerular filtration rate (GFR) ≤ 10 mL/min/1.73m² or currently undergoing renal replacement therapy (hemodialysis or peritoneal dialysis);
  8. Baseline platelet count <100,000/mm3;
  9. Known allergy or intolerance to aspirin, to all available ADP/P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor), or to bivalirudin or REG1 (or any of their respective components);
  10. The following planned procedures: a. Planned staged PCI procedure within 3 days after randomization; b. Planned CABG or valve surgery within 30 days after randomization;
  11. Any other medical or psychiatric condition that in the Investigator's judgment precludes participation in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01848106
Other Study ID Numbers  ICMJE REG1-CLIN310
2013-001384-23 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regado Biosciences, Inc.
Study Sponsor  ICMJE Regado Biosciences, Inc.
Collaborators  ICMJE
  • The Cleveland Clinic
  • Duke Clinical Research Institute
  • Canadian VIGOUR Centre
  • Icahn School of Medicine at Mount Sinai
  • Parexel
Investigators  ICMJE
Study Director: Steven L Zelenkofske, DO, FACC Regado Biosciences
Principal Investigator: A. Michael Lincoff, MD The Cleveland Clinic
Principal Investigator: Roxana Mehran, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: John H Alexander, MD, MHS Duke Clinical Research Institute
PRS Account Regado Biosciences, Inc.
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP