Angina, Stable, Angina, Unstable, Anticoagulants
Conditions
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.
Interventions
DEVICECOBRA PzF
DEVICEDrug Eluting Stent
Sponsors
CeloNova BioSciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Ischemia driven target lesion revascularization | 12 months | — |
| Definite and probable stent thrombosis | 12 months | — |
| Ischemic stroke | 12 months | — |
| Composite of all cause death, myocardial infarction, definite and probable stent thrombosis, ischemia-driven target lesion revascularization or ischemic stroke | 12 months | — |
| TIMI major bleeding; TIMI major and minor bleeding | 6 months | — |
| Acute Success Rates | procedure | Device success; Lesion success; Procedure success |
| Health economic utility | 12 months | Total cardiovascular and bleeding related costs with cost effectiveness based on events avoided |
| BARC class 3-5 bleeding | 6 months | — |
| Composite of cardiac death and myocardial infarction | 12 months | — |
Countries
Belgium, Denmark, France, Germany, Italy, Latvia, Switzerland, United States
Outcome results
None listed