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

NCT02594501 | Unknown DMC FDA Device

• 1 other identifier: COBRA 2015-01
• Study Type: interventional
• Target: 996
• Locations: 8 countries
• Sites: 48

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.

Conditions

Angina, Stable; Angina, Unstable; Anticoagulants

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Composite of all cause death, myocardial infarction, definite and probable stent thrombosis, ischemia-driven target lesion revascularization or ischemic stroke

  12 months

• Composite of cardiac death and myocardial infarction

  12 months

• Ischemia driven target lesion revascularization

  12 months

• Definite and probable stent thrombosis

  12 months

• Ischemic stroke

  12 months

Study Arms (2)

COBRA PzF

EXPERIMENTAL

Cobra PzF plus 14-day DAPT (dual antiplatelet therapy)

Device: COBRA PzF

Drug Eluting Stent

ACTIVE COMPARATOR

standard FDA-approved DES (Xience/Promus or Resolute) plus 3 or 6-month DAPT (dual anti-platelet therapy)

Device: Drug Eluting Stent

Interventions

COBRA PzF DEVICE

COBRA PzF

Drug Eluting Stent DEVICE

Also known as: Xience/Promus, Resolute or Synergy

Drug Eluting Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• CeloNova BioSciences, Inc.: lead

Study Sites (48)

Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

University of Florida

Jacksonville, Florida, 32209, United States

Location

Memorial Hospital Jacksonville

Jacksonville, Florida, 32216, United States

Location

Sebastian River Medical Center

Melbourne, Florida, 32901, United States

Location

Mt Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

University of Maryland St. Joseph Medical Center

Towson, Maryland, 21204, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Rutgers Robert Wood Johnson Medical Schoo

New Brunswick, New Jersey, 08901, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

North Ohio Heart Center

Elyria, Ohio, 44035, United States

Location

Cleveland Clinic

Fairview Park, Ohio, 44126, United States

Location

Mercy St. Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Texas Cardiac Center

Lubbock, Texas, 79410, United States

Location

Tyler Cardiovascular Consultants

Tyler, Texas, 75701, United States

Location

Sentara Heart Hospital (Sentara Cardiovascular Research Institute)

Norfolk, Virginia, 23507, United States

Location

Carilion Medical Center

Roanoke, Virginia, 24014, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

ZNA Middelheim

Antwerp, 2020, Belgium

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Clinique Axium

Aix, France

Location

Clinique Du Pont De Chaumes

Montauban, France

Location

Clinique du Millénaire

Montpellier, 34000, France

Location

Hopital Pitie-Salpitierre

Paris, 75013, France

Location

Höpital George Pompidou

Paris, France

Location

Clinique Pasteur

Toulouse, 31300, France

Location

Institut Lorrain du Coeur et Vaisseaux, CHU Nancy-Barbois

Vandœuvre-lès-Nancy, France

Location

Universitats Herzzentrum Freibourg

Bad Krozingen, 79819, Germany

Location

Charité - Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Uni-Klinikum Erlangen

Erlangen, Germany

Location

St. Josefskrankenhaus

Freiburg im Breisgau, Germany

Location

Klinikum Fürth

Fürth, Germany

Location

University of Jena

Jena, Germany

Location

MediClin Herzzentrum

Lahr, Germany

Location

Klinikum Landshut-Achdorf

Landshut, Germany

Location

Deutsches Herzzentrum München

Munich, Germany

Location

Klinikum Rechts der Isar München

Munich, Germany

Location

Universitätsklinikum Regensburg

Regensburg, Germany

Location

Hegau Bodensee Klinikum Singen

Singen, Germany

Location

Univesitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Ospedale Spaziani

Frosinone, Italy

Location

Paula Stradins Clinical University Hospital

Riga, LV-1002, Latvia

Location

Hopital Cantonal Fribourg

Fribourg, Switzerland

Location

Kantonspital St Galen

Sankt Gallen, Switzerland

Location

Related Publications (2)

• Byrne RA, Colleran R, Coughlan JJ, Jauhar R, Maillard L, De Labriolle A, Maeng M, Croft C, Brunner M, Leistner D, Zrenner B, Kollum M, Laugwitz KL, Xhepa E, Mayer K, Lahu S, Joner M, Kirtane A, Mehran R, Barakat M, Urban P, Cutlip DE, Kastrati A; COBRA-REDUCE Investigators. Randomized Trial of COBRA PzF Stenting to Reduce the Duration of Triple Therapy: The COBRA-REDUCE Trial. Circ Cardiovasc Interv. 2024 Oct;17(10):e013735. doi: 10.1161/CIRCINTERVENTIONS.123.013735. Epub 2024 Oct 15.

  PMID: 39405373 DERIVED

• Colleran R, Joner M, Cutlip D, Urban P, Maeng M, Jauhar R, Barakat M, Michel JM, Mehran R, Kirtane AJ, Maillard L, Kastrati A, Byrne RA; COBRA-REDUCE investigators. Design and Rationale of a Randomized Trial of COBRA PzF Stenting to REDUCE Duration of Triple Therapy (COBRA-REDUCE). Cardiovasc Revasc Med. 2022 Jan;34:17-24. doi: 10.1016/j.carrev.2021.01.022. Epub 2021 Jan 22.

  PMID: 33608239 DERIVED

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Adnan Kastrati

  ISAResearch Center Deutsches Herzzentrum München

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 3, 2015
• Study Start: February 5, 2016
• Primary Completion: May 1, 2021
• Study Completion: November 1, 2021
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); CH (2); DK (1); DE (13); LA (1); US (22); FR (7); IT (1)