Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy

Not Applicable

• Conditions: Angina, Stable; Anticoagulants; Angina, Unstable
• Interventions: Device: Drug Eluting Stent; Device: COBRA PzF

• Registration Number: NCT02594501
• Lead Sponsor: CeloNova BioSciences, Inc.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-03
• Study Start: 2016-02-05
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-26
• Primary Completion: 2021-05
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 996

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug Eluting Stent	Drug Eluting Stent	standard FDA-approved DES (Xience/Promus or Resolute) plus 3 or 6-month DAPT (dual anti-platelet therapy)
COBRA PzF	COBRA PzF	Cobra PzF plus 14-day DAPT (dual antiplatelet therapy)

Primary Outcome Measures

Name	Time	Method
BARC class >=2 bleeding after hospital discharge (or beyond 14 days, whichever is "later").	6 months
Composite of all cause death, myocardial infarction, definite and probable stent thrombosis or ischemic stroke	6 months

Secondary Outcome Measures

Name	Time	Method
BARC class 3-5 bleeding	6 months
Ischemic stroke	12 months
Composite of cardiac death and myocardial infarction	12 months
Ischemia driven target lesion revascularization	12 months
TIMI major bleeding; TIMI major and minor bleeding	6 months
Health economic utility	12 months	Total cardiovascular and bleeding related costs with cost effectiveness based on events avoided
Composite of all cause death, myocardial infarction, definite and probable stent thrombosis, ischemia-driven target lesion revascularization or ischemic stroke	12 months
Definite and probable stent thrombosis	12 months
Acute Success Rates	procedure	Device success; Lesion success; Procedure success

Trial Locations

Locations (48)

Clinique du Millénaire; 🇫🇷 Montpellier, France

University of Jena; 🇩🇪 Jena, Germany

Christiana Care Health Services; 🇺🇸 Newark, Delaware, 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

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Maryland St. Joseph Medical Center; 🇺🇸 Towson, Maryland, 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

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

Tyler Cardiovascular Consultants; 🇺🇸 Tyler, Texas, United States

Texas Cardiac Center; 🇺🇸 Lubbock, Texas, United States

Charleston Area Medical Center; 🇺🇸 Charleston, West Virginia, United States

Sentara Heart Hospital (Sentara Cardiovascular Research Institute); 🇺🇸 Norfolk, Virginia, United States

Carilion Medical Center; 🇺🇸 Roanoke, Virginia, United States

ZNA Middelheim; 🇧🇪 Antwerp, Belgium

Clinique Axium; 🇫🇷 Aix, France

Clinique Du Pont De Chaumes; 🇫🇷 Montauban, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Institut Lorrain du Coeur et Vaisseaux, CHU Nancy-Barbois; 🇫🇷 Vandœuvre-lès-Nancy, France

Höpital George Pompidou; 🇫🇷 Paris, France

Charité - Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Universitats Herzzentrum Freibourg; 🇩🇪 Bad Krozingen, Germany

Uni-Klinikum Erlangen; 🇩🇪 Erlangen, Germany

Klinikum Fürth; 🇩🇪 Fürth, Germany

St. Josefskrankenhaus; 🇩🇪 Freiburg, 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

Univesitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

Ospedale Spaziani; 🇮🇹 Frosinone, Italy

Hopital Cantonal Fribourg; 🇨🇭 Fribourg, Switzerland

Kantonspital St Galen; 🇨🇭 St Gallen, Switzerland

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

NYU Winthrop Hospital; 🇺🇸 Mineola, New York, United States

Paula Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

Minneapolis Heart Institute; 🇺🇸 Minneapolis, Minnesota, United States

University of Florida; 🇺🇸 Jacksonville, Florida, United States

Augusta University; 🇺🇸 Augusta, Georgia, United States

Hopital Pitie-Salpitierre; 🇫🇷 Paris, France

Hegau Bodensee Klinikum Singen; 🇩🇪 Singen, Germany