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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01848106
Recruitment Status : Terminated (Clinical Hold)
First Posted : May 7, 2013
Last Update Posted : October 23, 2014
The Cleveland Clinic
Duke Clinical Research Institute
Canadian VIGOUR Centre
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Regado Biosciences, Inc.

May 2, 2013
May 7, 2013
October 23, 2014
September 2013
August 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01848106 on Archive Site
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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.

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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Lincoff AM, Mehran R, Povsic TJ, Zelenkofske SL, Huang Z, Armstrong PW, Steg PG, Bode C, Cohen MG, Buller C, Laanmets P, Valgimigli M, Marandi T, Fridrich V, Cantor WJ, Merkely B, Lopez-Sendon J, Cornel JH, Kasprzak JD, Aschermann M, Guetta V, Morais J, Sinnaeve PR, Huber K, Stables R, Sellers MA, Borgman M, Glenn L, Levinson AI, Lopes RD, Hasselblad V, Becker RC, Alexander JH; REGULATE-PCI Investigators. Effect of the REG1 anticoagulation system versus bivalirudin on outcomes after percutaneous coronary intervention (REGULATE-PCI): a randomised clinical trial. Lancet. 2016 Jan 23;387(10016):349-356. doi: 10.1016/S0140-6736(15)00515-2. Epub 2015 Nov 5. Erratum in: Lancet. 2016 Mar 19;387(10024):1162. Boudoulas, Dean [corrected to Boudoulas, Konstantinos D.].

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
2013-001384-23 ( EudraCT Number )
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Regado Biosciences, Inc.
Regado Biosciences, Inc.
  • The Cleveland Clinic
  • Duke Clinical Research Institute
  • Canadian VIGOUR Centre
  • Icahn School of Medicine at Mount Sinai
  • Parexel
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
Regado Biosciences, Inc.
October 2014

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