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



Status:Recruiting
Conditions:Angina, Angina
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/16/2018
Start Date:February 5, 2016
End Date:December 2020
Contact:Dirk Pauwels
Email:dpauwels@celonova.com
Phone:+41 152 6588 4291

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

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.


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
We found this trial at
28
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New York, New York 10029
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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1 Lindendreef
Antwerp, 2020
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Augusta, Georgia 30912
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Beverly Hills, California 90211
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Browns Mills, New Jersey 08015
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Camp Hill, PA
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Charleston, West Virginia 25304
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Elyria, Ohio 44035
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Fairview Park, Ohio 44126
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Fort Worth, Texas 76104
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Jacksonville, Florida 32209
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Jacksonville, Florida 32216
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Lubbock, Texas 79410
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Manhasset, New York 11030
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Melbourne, Florida 32901
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Miami Beach, Florida 33140
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259 1st Street
Mineola, New York 11501
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Minneapolis, Minnesota 55407
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New Brunswick, New Jersey 08901
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Newark, Delaware 19713
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Philadelphia, Pennsylvania 19141
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Roanoke, Virginia 24014
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