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

Angina, Unstable Clinical Trial

— COBRA-REDUCE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02594501
• Other study ID #: COBRA 2015-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 5, 2016
• Est. completion date: November 2021

Study information

• Verified date: October 2020
• Source: CeloNova BioSciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 996
• Est. completion date: November 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Anticoagulants

Intervention

Device:
• COBRA PzF

• Drug Eluting Stent

Locations

Country	Name	City	State
Belgium	ZNA Middelheim	Antwerp
Denmark	Aarhus University Hospital	Aarhus
France	Clinique Axium	Aix
France	Clinique Du Pont De Chaumes	Montauban
France	Clinique du Millénaire	Montpellier
France	Höpital George Pompidou	Paris
France	Hopital Pitie-Salpitierre	Paris
France	Clinique Pasteur	Toulouse
France	Institut Lorrain du Coeur et Vaisseaux, CHU Nancy-Barbois	Vandœuvre-lès-Nancy
Germany	Universitats Herzzentrum Freibourg	Bad Krozingen
Germany	Charite´ - Campus Benjamin Franklin	Berlin
Germany	Uni-Klinikum Erlangen	Erlangen
Germany	St. Josefskrankenhaus	Freiburg
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
Italy	Ospedale Spaziani	Frosinone
Latvia	Paula Stradins Clinical University Hospital	Riga
Switzerland	Hopital Cantonal Fribourg	Fribourg
Switzerland	Kantonspital St Galen	St Gallen
United States	Augusta University	Augusta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Deborah Heart and Lung Center	Browns Mills	New Jersey
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	North Ohio Heart Center	Elyria	Ohio
United States	Cleveland Clinic	Fairview Park	Ohio
United States	Memorial Hospital Jacksonville	Jacksonville	Florida
United States	University of Florida	Jacksonville	Florida
United States	Texas Cardiac Center	Lubbock	Texas
United States	Northwell Health	Manhasset	New York
United States	Sebastian River Medical Center	Melbourne	Florida
United States	Mt Sinai Medical Center	Miami Beach	Florida
United States	NYU Winthrop Hospital	Mineola	New York
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Rutgers Robert Wood Johnson Medical Schoo	New Brunswick	New Jersey
United States	Christiana Care Health Services	Newark	Delaware
United States	Sentara Heart Hospital (Sentara Cardiovascular Research Institute)	Norfolk	Virginia
United States	Einstein Medical Center	Philadelphia	Pennsylvania
United States	Carilion Medical Center	Roanoke	Virginia
United States	Mercy St. Vincent Medical Center	Toledo	Ohio
United States	University of Maryland St. Joseph Medical Center	Towson	Maryland
United States	Tyler Cardiovascular Consultants	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
CeloNova BioSciences, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Germany,  Italy,  Latvia,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BARC class >=2 bleeding after hospital discharge (or beyond 14 days, whichever is "later").		6 months
Primary	Composite of all cause death, myocardial infarction, definite and probable stent thrombosis or ischemic stroke		6 months
Secondary	Composite of all cause death, myocardial infarction, definite and probable stent thrombosis, ischemia-driven target lesion revascularization or ischemic stroke		12 months
Secondary	Composite of cardiac death and myocardial infarction		12 months
Secondary	Ischemia driven target lesion revascularization		12 months
Secondary	Definite and probable stent thrombosis		12 months
Secondary	Ischemic stroke		12 months
Secondary	BARC class 3-5 bleeding		6 months
Secondary	TIMI major bleeding; TIMI major and minor bleeding		6 months
Secondary	Acute Success Rates	Device success; Lesion success; Procedure success	procedure
Secondary	Health economic utility	Total cardiovascular and bleeding related costs with cost effectiveness based on events avoided	12 months