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

This study has been terminated.
(Clinical Hold)
Sponsor:
Collaborators:
The Cleveland Clinic
Duke Clinical Research Institute
Canadian VIGOUR Centre
Mount Sinai School of Medicine
Parexel
Information provided by (Responsible Party):
Regado Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01848106
First received: May 2, 2013
Last updated: October 22, 2014
Last verified: October 2014

May 2, 2013
October 22, 2014
September 2013
August 2014   (final data collection date for primary outcome measure)
Ischemic composite [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
The primary efficacy endpoint is the composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 3.
Same as current
Complete list of historical versions of study NCT01848106 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Drug: pegnivacogin/anivamersen
    Other Name: Reg 1 Anticoagulation System
  • Drug: Bivalirudin
    Other Name: Angiox, Angiomax
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3232
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01848106
REG1-CLIN310, 2013-001384-23
Yes
Regado Biosciences, Inc.
Regado Biosciences, Inc.
  • The Cleveland Clinic
  • Duke Clinical Research Institute
  • Canadian VIGOUR Centre
  • Mount Sinai School of Medicine
  • Parexel
Study Director: Steven L Zelenkofske, DO, FACC Regado Biosciences
Principal Investigator: A. Michael Lincoff, MD The Cleveland Clinic
Principal Investigator: Roxana Mehran, MD Mount Sinai School of Medicine
Principal Investigator: John H Alexander, MD, MHS Duke Clinical Research Institute
Regado Biosciences, Inc.
October 2014

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