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

This study has suspended participant recruitment.
(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: July 9, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: pegnivacogin/anivamersen
Drug: Bivalirudin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Regado Biosciences, Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 13200
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bivalirudin
Bivalirudin bolus and infusion
Drug: Bivalirudin
Other Name: Angiox, Angiomax
Experimental: Reg 1 (pegnivacogin/anivamersen)
Bolus pegnivacogin plus anivamersen active control agent
Drug: pegnivacogin/anivamersen
Other Name: Reg 1 Anticoagulation System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848106

Locations
United States, South Dakota
Black Hills Cardiovascular Research
Rapid City, South Dakota, United States, 57701
Sponsors and Collaborators
Regado Biosciences, Inc.
The Cleveland Clinic
Duke Clinical Research Institute
Canadian VIGOUR Centre
Mount Sinai School of Medicine
Parexel
Investigators
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
  More Information

No publications provided

Responsible Party: Regado Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01848106     History of Changes
Other Study ID Numbers: REG1-CLIN310, 2013-001384-23
Study First Received: May 2, 2013
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Regado Biosciences, Inc.:
Percutaneous Coronary Intervention
Coronary Artery Disease
Acute Coronary Syndrome
Regado
Reg 1
bivalirudin

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Bivalirudin
Hirudins
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 26, 2014