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 |
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.
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
sites
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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