Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy (COBRA-REDUCE)

October 23, 2020 updated by: CeloNova BioSciences, Inc.

COBRA PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention

The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
996

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2020
        • ZNA Middelheim
  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital
  • France
      • Aix, France
        • Clinique Axium
      • Montauban, France
        • Clinique Du Pont De Chaumes
      • Montpellier, France, 34000
        • Clinique du Millénaire
      • Paris, France, 75013
        • Hopital Pitie-Salpitierre
      • Paris, France
        • hôpital george Pompidou
      • Toulouse, France, 31300
        • Clinique Pasteur
      • Vandœuvre-lès-Nancy, France
        • Institut Lorrain du Coeur et Vaisseaux, CHU Nancy-Barbois
  • Germany
      • Bad Krozingen, Germany, 79819
        • Universitats Herzzentrum Freibourg
      • Berlin, Germany, 12203
        • Charite - Campus Benjamin Franklin
      • Erlangen, Germany
        • Uni-Klinikum Erlangen
      • Freiburg, Germany
        • St. Josefskrankenhaus
      • Fürth, Germany
        • Klinikum Fürth
      • Jena, Germany
        • University of Jena
      • Lahr, Germany
        • MediClin Herzzentrum
      • Landshut, Germany
        • Klinikum Landshut-Achdorf
      • Munich, Germany
        • Deutsches Herzzentrum München
      • Munich, Germany
        • Klinikum rechts der Isar München
      • Regensburg, Germany
        • Universitätsklinikum Regensburg
      • Singen, Germany
        • Hegau Bodensee Klinikum Singen
      • Tübingen, Germany, 72076
        • Univesitätsklinikum Tübingen
  • Italy
      • Frosinone, Italy
        • Ospedale Spaziani
  • Latvia
      • Riga, Latvia, LV-1002
        • Paula Stradins Clinical University Hospital
  • Switzerland
      • Fribourg, Switzerland
        • Hopital cantonal Fribourg
      • St Gallen, Switzerland
        • Kantonspital St Galen
  • United States
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health Services
    • Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida
      • Jacksonville, Florida, United States, 32216
        • Memorial Hospital Jacksonville
      • Melbourne, Florida, United States, 32901
        • Sebastian River Medical Center
      • Miami Beach, Florida, United States, 33140
        • Mt Sinai Medical Center
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University
    • Maryland
      • Towson, Maryland, United States, 21204
        • University of Maryland St. Joseph Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Robert Wood Johnson Medical Schoo
    • New York
      • Manhasset, New York, United States, 11030
        • Northwell Health
      • Mineola, New York, United States, 11501
        • NYU Winthrop Hospital
    • Ohio
      • Elyria, Ohio, United States, 44035
        • North Ohio Heart Center
      • Fairview Park, Ohio, United States, 44126
        • Cleveland Clinic
      • Toledo, Ohio, United States, 43608
        • Mercy St. Vincent Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Einstein Medical Center
    • Texas
      • Lubbock, Texas, United States, 79410
        • Texas Cardiac Center
      • Tyler, Texas, United States, 75701
        • Tyler Cardiovascular Consultants
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Heart Hospital (Sentara Cardiovascular Research Institute)
      • Roanoke, Virginia, United States, 24014
        • Carilion Medical Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Area Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than age 18 with ischemic symptoms (stable or unstable angina or NSTEMI without thrombosis of the target lesion on coronary angiography) or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary vessels (max. 2 lesions in one or 2 separate vessels).
  • Patient receiving or with an indication for new treatment with long-term oral anticoagulation with a coumadin derivatives or non-vitamin K oral anticoagulants.
  • Written, informed consent

Exclusion Criteria:

  • Cardiogenic shock
  • Target lesion located in left main trunk
  • Bifurcation interventions with a planned 2-stent strategy
  • Vessel size too small for implantation of a 2.5 mm stent by visual estimation
  • Patient requiring staging PCI procedure within 6 months after the index procedure
  • Patients requiring DAPT for more than 2 weeks after the index procedure
  • Contraindications or allergy to cobalt, chromium, platinum, polyzene-F, everolimus, zotarolimus or the inability to take triple therapy for at least 6 months
  • Relevant hematologic deviations: platelet count <100x10^9 cells/L or >600x10^9 cells/L
  • Active bleeding; bleeding diathesis; recent trauma or major surgery in the last month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection
  • Malignancies or other co-morbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance
  • Pregnancy, present (positive pregnancy test), suspected or planned, breast feeding
  • Known allergy or intolerance to the study medications: ASA, clopidogrel, coumadin and its derivatives
  • Patient's inability to fully cooperate with the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: COBRA PzF
Cobra PzF plus 14-day DAPT (dual antiplatelet therapy)
Device: COBRA PzF
Active Comparator: Drug Eluting Stent
standard FDA-approved DES (Xience/Promus or Resolute) plus 3 or 6-month DAPT (dual anti-platelet therapy)
Device: Drug Eluting Stent
Other Names:
  • Xience/Promus, Resolute or Synergy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
BARC class >=2 bleeding after hospital discharge (or beyond 14 days, whichever is "later").
Time Frame: 6 months
6 months
Composite of all cause death, myocardial infarction, definite and probable stent thrombosis or ischemic stroke
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ischemic stroke
Time Frame: 12 months
12 months
Composite of all cause death, myocardial infarction, definite and probable stent thrombosis, ischemia-driven target lesion revascularization or ischemic stroke
Time Frame: 12 months
12 months
Composite of cardiac death and myocardial infarction
Time Frame: 12 months
12 months
Ischemia driven target lesion revascularization
Time Frame: 12 months
12 months
Definite and probable stent thrombosis
Time Frame: 12 months
12 months
BARC class 3-5 bleeding
Time Frame: 6 months
6 months
TIMI major bleeding; TIMI major and minor bleeding
Time Frame: 6 months
6 months
Acute Success Rates
Time Frame: procedure
Device success; Lesion success; Procedure success
procedure
Health economic utility
Time Frame: 12 months
Total cardiovascular and bleeding related costs with cost effectiveness based on events avoided
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CeloNova BioSciences, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Adnan Kastrati, ISAResearch Center Deutsches Herzzentrum München

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COBRA 2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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