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

Not Applicable

• Conditions: Angina, Stable; Anticoagulants; Angina, Unstable

• Registration Number: NCT02594501
• Lead Sponsor: CeloNova BioSciences, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-03
• Study Start: 2016-02-05
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-26
• Primary Completion: 2021-05
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 996

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Ischemic stroke	12 months
Composite of cardiac death and myocardial infarction	12 months
Ischemia driven target lesion revascularization	12 months
TIMI major bleeding; TIMI major and minor bleeding	6 months
Health economic utility	12 months	Total cardiovascular and bleeding related costs with cost effectiveness based on events avoided
Composite of all cause death, myocardial infarction, definite and probable stent thrombosis, ischemia-driven target lesion revascularization or ischemic stroke	12 months
Definite and probable stent thrombosis	12 months
Acute Success Rates	procedure	Device success; Lesion success; Procedure success
BARC class 3-5 bleeding	6 months

Trial Locations

Locations (48)

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

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