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

Status unconfirmed · Not applicable

Conditions studied: Angina, Stable, Angina, Unstable, Anticoagulants

In brief

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.

Key facts

Study ID

NCT02594501

Run by

CeloNova BioSciences, Inc.

People needed

996

Starts

2016-02-05

Expected to finish

2021-11-01

Last updated by the study team

2020-10-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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