Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy
NCT ID: NCT02594501
Last Updated: 2020-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
996 participants
INTERVENTIONAL
2016-02-05
2021-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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COBRA PzF
Cobra PzF plus 14-day DAPT (dual antiplatelet therapy)
COBRA PzF
Drug Eluting Stent
standard FDA-approved DES (Xience/Promus or Resolute) plus 3 or 6-month DAPT (dual anti-platelet therapy)
Drug Eluting Stent
Interventions
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COBRA PzF
Drug Eluting Stent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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CeloNova BioSciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Adnan Kastrati
Role: STUDY_CHAIR
ISAResearch Center Deutsches Herzzentrum München
Locations
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Christiana Care Health Services
Newark, Delaware, United States
University of Florida
Jacksonville, Florida, United States
Memorial Hospital Jacksonville
Jacksonville, Florida, United States
Sebastian River Medical Center
Melbourne, Florida, United States
Mt Sinai Medical Center
Miami Beach, Florida, United States
Augusta University
Augusta, Georgia, United States
University of Maryland St. Joseph Medical Center
Towson, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Rutgers Robert Wood Johnson Medical Schoo
New Brunswick, New Jersey, United States
Northwell Health
Manhasset, New York, United States
NYU Winthrop Hospital
Mineola, New York, United States
North Ohio Heart Center
Elyria, Ohio, United States
Cleveland Clinic
Fairview Park, Ohio, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, United States
Einstein Medical Center
Philadelphia, Pennsylvania, United States
Texas Cardiac Center
Lubbock, Texas, United States
Tyler Cardiovascular Consultants
Tyler, Texas, United States
Sentara Heart Hospital (Sentara Cardiovascular Research Institute)
Norfolk, Virginia, United States
Carilion Medical Center
Roanoke, Virginia, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
ZNA Middelheim
Antwerp, , Belgium
Aarhus University Hospital
Aarhus, , Denmark
Clinique Axium
Aix, , France
Clinique Du Pont De Chaumes
Montauban, , France
Clinique du Millénaire
Montpellier, , France
Hopital Pitie-Salpitierre
Paris, , France
Höpital George Pompidou
Paris, , France
Clinique Pasteur
Toulouse, , France
Institut Lorrain du Coeur et Vaisseaux, CHU Nancy-Barbois
Vandœuvre-lès-Nancy, , France
Universitats Herzzentrum Freibourg
Bad Krozingen, , Germany
Charité - Campus Benjamin Franklin
Berlin, , Germany
Uni-Klinikum Erlangen
Erlangen, , Germany
St. Josefskrankenhaus
Freiburg im Breisgau, , Germany
Klinikum Fürth
Fürth, , Germany
University of Jena
Jena, , Germany
MediClin Herzzentrum
Lahr, , Germany
Klinikum Landshut-Achdorf
Landshut, , Germany
Deutsches Herzzentrum München
Munich, , Germany
Klinikum Rechts der Isar München
Munich, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
Hegau Bodensee Klinikum Singen
Singen, , Germany
Univesitätsklinikum Tübingen
Tübingen, , Germany
Ospedale Spaziani
Frosinone, , Italy
Paula Stradins Clinical University Hospital
Riga, , Latvia
Hopital Cantonal Fribourg
Fribourg, , Switzerland
Kantonspital St Galen
Sankt Gallen, , Switzerland
Countries
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References
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Byrne RA, Colleran R, Coughlan JJ, Jauhar R, Maillard L, De Labriolle A, Maeng M, Croft C, Brunner M, Leistner D, Zrenner B, Kollum M, Laugwitz KL, Xhepa E, Mayer K, Lahu S, Joner M, Kirtane A, Mehran R, Barakat M, Urban P, Cutlip DE, Kastrati A; COBRA-REDUCE Investigators. Randomized Trial of COBRA PzF Stenting to Reduce the Duration of Triple Therapy: The COBRA-REDUCE Trial. Circ Cardiovasc Interv. 2024 Oct;17(10):e013735. doi: 10.1161/CIRCINTERVENTIONS.123.013735. Epub 2024 Oct 15.
Colleran R, Joner M, Cutlip D, Urban P, Maeng M, Jauhar R, Barakat M, Michel JM, Mehran R, Kirtane AJ, Maillard L, Kastrati A, Byrne RA; COBRA-REDUCE investigators. Design and Rationale of a Randomized Trial of COBRA PzF Stenting to REDUCE Duration of Triple Therapy (COBRA-REDUCE). Cardiovasc Revasc Med. 2022 Jan;34:17-24. doi: 10.1016/j.carrev.2021.01.022. Epub 2021 Jan 22.
Other Identifiers
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COBRA 2015-01
Identifier Type: -
Identifier Source: org_study_id