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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
pegnivacogin/anivamersen
Bivalirudin
Sponsored by
Regado Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous Coronary Intervention, Coronary Artery Disease, Acute Coronary Syndrome, Regado, Reg 1, bivalirudin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Black Hills Cardiovascular Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bivalirudin

Reg 1 (pegnivacogin/anivamersen)

Arm Description

Bivalirudin bolus and infusion

Bolus pegnivacogin plus anivamersen active control agent

Outcomes

Primary Outcome Measures

Ischemic composite
The primary efficacy endpoint is the composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 3.

Secondary Outcome Measures

Full Information

First Posted
May 2, 2013
Last Updated
October 22, 2014
Sponsor
Regado Biosciences, Inc.
Collaborators
The Cleveland Clinic, Duke Clinical Research Institute, Canadian VIGOUR Centre, Icahn School of Medicine at Mount Sinai, Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT01848106
Brief Title
A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI
Acronym
Regulate
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
Clinical Hold
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regado Biosciences, Inc.
Collaborators
The Cleveland Clinic, Duke Clinical Research Institute, Canadian VIGOUR Centre, Icahn School of Medicine at Mount Sinai, Parexel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Percutaneous Coronary Intervention, Coronary Artery Disease, Acute Coronary Syndrome, Regado, Reg 1, bivalirudin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bivalirudin
Arm Type
Active Comparator
Arm Description
Bivalirudin bolus and infusion
Arm Title
Reg 1 (pegnivacogin/anivamersen)
Arm Type
Experimental
Arm Description
Bolus pegnivacogin plus anivamersen active control agent
Intervention Type
Drug
Intervention Name(s)
pegnivacogin/anivamersen
Other Intervention Name(s)
Reg 1 Anticoagulation System
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Other Intervention Name(s)
Angiox, Angiomax
Primary Outcome Measure Information:
Title
Ischemic composite
Description
The primary efficacy endpoint is the composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 3.
Time Frame
Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The study population will consist of patients with CAD undergoing PCI. Three key subgroups will be included Willing and able to sign an Institutional Review Board/Ethics Committee (IRB/EC) approved informed consent prior to any study-related activities; Male or female age 18 or greater; 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; Subject is able and willing to comply with the protocol and all study procedures Exclusion Criteria: Acute ST-segment elevation myocardial infarction within 48 hours of randomization; Evidence of current clinical instability Evidence of a contraindication to anticoagulation or increased risk of bleeding 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); Use of the select antithrombotic agents Baseline hemoglobin (Hgb) <9 g/dL or equivalent; Baseline estimated glomerular filtration rate (GFR) ≤ 10 mL/min/1.73m² or currently undergoing renal replacement therapy (hemodialysis or peritoneal dialysis); Baseline platelet count <100,000/mm3; 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); 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; Any other medical or psychiatric condition that in the Investigator's judgment precludes participation in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven L Zelenkofske, DO, FACC
Organizational Affiliation
Regado Biosciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
A. Michael Lincoff, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roxana Mehran, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John H Alexander, MD, MHS
Organizational Affiliation
Duke Clinical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Black Hills Cardiovascular Research
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30957581
Citation
Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
Results Reference
derived
PubMed Identifier
26547100
Citation
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.].
Results Reference
derived

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

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