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Coronary Artery DiseasePhase 3RegulateNCT01848106

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

A Phase 3 study testing pegnivacogin/anivamersen and Bivalirudin in people with Coronary Artery Disease, run by Regado Biosciences, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
pegnivacogin/anivamersen and Bivalirudin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,232 participants
Where
1 siteUnited States
Study dates
Sep 2013to Aug 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Black Hills Cardiovascular Research

    Rapid City, South Dakota, 57701

Other trials in United States

About this study

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

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.

Being tested
pegnivacogin/anivamersen, Bivalirudin
Keywords
Percutaneous Coronary Intervention, Coronary Artery Disease, Acute Coronary Syndrome, Regado, Reg 1, bivalirudin
Medical subject headings
Coronary Artery Disease, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pegnivacogin/anivamersenDrug

    Also called Reg 1 Anticoagulation System

  • BivalirudinDrug

    Also called Angiox, Angiomax

Study groups in NCT01848106
Study groupRoleWhat they receive
BivalirudinActive comparatorBivalirudin bolus and infusion
Receives: Drug: Bivalirudin
Reg 1 (pegnivacogin/anivamersen)ExperimentalBolus pegnivacogin plus anivamersen active control agent
Receives: Drug: pegnivacogin/anivamersen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ischemic composite

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

    Measured: Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionAug 2014
  4. Study completionAug 2014

Why it stopped: Clinical Hold

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,232 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01848106
Sponsor's protocol ID
REG1-CLIN310
Other IDs
2013-001384-23
Acronym
Regulate
Status last verified
Oct 2014
First submitted
2 May 2013
Last updated
23 Oct 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Marquis-Gravel G, Boivin-Proulx LA, Huang Z, Zelenkofske SL, Lincoff AM, Mehran R, Steg PG, Bode C, Alexander JH, Povsic TJ. Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary Intervention. J Am Heart Assoc. 2023 Jan 3;12(1):e025666. doi: 10.1161/JAHA.122.025666. Epub 2022 Dec 30.

    PubMed 36583436

  • 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.

    PubMed 30957581

  • 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.

    PubMed 26547100

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pegnivacogin/anivamersen and Bivalirudin in people with Coronary Artery Disease, run by Regado Biosciences, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Clinical Hold). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ischemic composite (time frame: Day 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01848106, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2014.

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