Clinical trial NCT02594501: Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy
Official title: COBRA PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Angina, Stable
Angina, Unstable
Anticoagulants
Lead sponsor: CeloNova BioSciences, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-03
Enrollment: 996
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: BARC class >=2 bleeding after hospital discharge (or beyond 14 days, whichever is "later").
timeFrame: 6 months
measure: Composite of all cause death, myocardial infarction, definite and probable stent thrombosis or ischemic stroke
timeFrame: 6 months
Secondary outcomes:
measure: Composite of all cause death, myocardial infarction, definite and probable stent thrombosis, ischemia-driven target lesion revascularization or ischemic stroke
timeFrame: 12 months
measure: Composite of cardiac death and myocardial infarction
timeFrame: 12 months
measure: Ischemia driven target lesion revascularization
timeFrame: 12 months
measure: Definite and probable stent thrombosis
timeFrame: 12 months
measure: Ischemic stroke
timeFrame: 12 months
measure: BARC class 3-5 bleeding
timeFrame: 6 months
measure: TIMI major bleeding; TIMI major and minor bleeding
timeFrame: 6 months
measure: Acute Success Rates
timeFrame: procedure
measure: Health economic utility
timeFrame: 12 months
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Memorial Hospital Jacksonville
state: Florida
city: Melbourne
country: United States
facility: Sebastian River Medical Center
state: Florida
city: Miami Beach
country: United States
facility: Mt Sinai Medical Center
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Towson
country: United States
facility: University of Maryland St. Joseph Medical Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical Schoo
state: New Jersey
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Hospital
state: New York
city: Elyria
country: United States
facility: North Ohio Heart Center
state: Ohio
city: Fairview Park
country: United States
facility: Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: Mercy St. Vincent Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: Lubbock
country: United States
facility: Texas Cardiac Center
state: Texas
city: Tyler
country: United States
facility: Tyler Cardiovascular Consultants
state: Texas
city: Norfolk
country: United States
facility: Sentara Heart Hospital (Sentara Cardiovascular Research Institute)
state: Virginia
city: Roanoke
country: United States
facility: Carilion Medical Center
state: Virginia
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Aix
country: France
facility: Clinique Axium
city: Montauban
country: France
facility: Clinique Du Pont De Chaumes
city: Montpellier
country: France
facility: Clinique du Millénaire
city: Paris
country: France
facility: Hopital Pitie-Salpitierre
city: Paris
country: France
facility: Höpital George Pompidou
city: Toulouse
country: France
facility: Clinique Pasteur
city: Vandœuvre-lès-Nancy
country: France
facility: Institut Lorrain du Coeur et Vaisseaux, CHU Nancy-Barbois
city: Bad Krozingen
country: Germany
facility: Universitats Herzzentrum Freibourg
city: Berlin
country: Germany
facility: Charité - Campus Benjamin Franklin
city: Erlangen
country: Germany
facility: Uni-Klinikum Erlangen
city: Freiburg
country: Germany
facility: St. Josefskrankenhaus
city: Fürth
country: Germany
facility: Klinikum Fürth
city: Jena
country: Germany
facility: University of Jena
city: Lahr
country: Germany
facility: MediClin Herzzentrum
city: Landshut
country: Germany
facility: Klinikum Landshut-Achdorf
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
city: Munich
country: Germany
facility: Klinikum Rechts der Isar München
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Singen
country: Germany
facility: Hegau Bodensee Klinikum Singen
city: Tübingen
country: Germany
facility: Univesitätsklinikum Tübingen
city: Frosinone
country: Italy
facility: Ospedale Spaziani
city: Riga
country: Latvia
facility: Paula Stradins Clinical University Hospital
city: Fribourg
country: Switzerland
facility: Hopital Cantonal Fribourg
city: St Gallen
country: Switzerland
facility: Kantonspital St Galen
Study officials:
affiliation: ISAResearch Center Deutsches Herzzentrum München
name: Adnan Kastrati
role: STUDY_CHAIR
References:
citation: 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.