Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy (COBRA-REDUCE)

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.

Study Overview

• Status: Unknown
• Conditions: Angina, Stable; Angina, Unstable; Anticoagulants
• Intervention / Treatment: Device: COBRA PzF; Device: Drug Eluting Stent

• Study Type: Interventional
• Enrollment (Actual): 996
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
• Denmark
  • Aarhus, Denmark
    • Aarhus University Hospital
• France
  • Aix, France
    • Clinique Axium
  • Montauban, France
    • Clinique Du Pont De Chaumes
  • Montpellier, France, 34000
    • Clinique du Millénaire
  • Paris, France, 75013
    • Hopital Pitie-Salpitierre
  • Paris, France
    • hôpital george Pompidou
  • Toulouse, France, 31300
    • Clinique Pasteur
  • Vandœuvre-lès-Nancy, France
    • Institut Lorrain du Coeur et Vaisseaux, CHU Nancy-Barbois
• Germany
  • Bad Krozingen, Germany, 79819
    • Universitats Herzzentrum Freibourg
  • Berlin, Germany, 12203
    • Charite - Campus Benjamin Franklin
  • Erlangen, Germany
    • Uni-Klinikum Erlangen
  • Freiburg, Germany
    • St. Josefskrankenhaus
  • Fürth, Germany
    • Klinikum Fürth
  • Jena, Germany
    • University of Jena
  • Lahr, Germany
    • MediClin Herzzentrum
  • Landshut, Germany
    • Klinikum Landshut-Achdorf
  • Munich, Germany
    • Deutsches Herzzentrum München
  • Munich, Germany
    • Klinikum rechts der Isar München
  • Regensburg, Germany
    • Universitätsklinikum Regensburg
  • Singen, Germany
    • Hegau Bodensee Klinikum Singen
  • Tübingen, Germany, 72076
    • Univesitätsklinikum Tübingen
• Italy
  • Frosinone, Italy
    • Ospedale Spaziani
• Latvia
  • Riga, Latvia, LV-1002
    • Paula Stradins Clinical University Hospital
• Switzerland
  • Fribourg, Switzerland
    • Hopital cantonal Fribourg
  • St Gallen, Switzerland
    • Kantonspital St Galen
• United States
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health Services
  • Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida
    • Jacksonville, Florida, United States, 32216
      • Memorial Hospital Jacksonville
    • Melbourne, Florida, United States, 32901
      • Sebastian River Medical Center
    • Miami Beach, Florida, United States, 33140
      • Mt Sinai Medical Center
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Maryland
    • Towson, Maryland, United States, 21204
      • University of Maryland St. Joseph Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart and Lung Center
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Robert Wood Johnson Medical Schoo
  • New York
    • Manhasset, New York, United States, 11030
      • Northwell Health
    • Mineola, New York, United States, 11501
      • NYU Winthrop Hospital
  • Ohio
    • Elyria, Ohio, United States, 44035
      • North Ohio Heart Center
    • Fairview Park, Ohio, United States, 44126
      • Cleveland Clinic
    • Toledo, Ohio, United States, 43608
      • Mercy St. Vincent Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Einstein Medical Center
  • Texas
    • Lubbock, Texas, United States, 79410
      • Texas Cardiac Center
    • Tyler, Texas, United States, 75701
      • Tyler Cardiovascular Consultants
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Heart Hospital (Sentara Cardiovascular Research Institute)
    • Roanoke, Virginia, United States, 24014
      • Carilion Medical Center
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COBRA PzF; Cobra PzF plus 14-day DAPT (dual antiplatelet therapy)	Device: COBRA PzF
Active Comparator: Drug Eluting Stent; standard FDA-approved DES (Xience/Promus or Resolute) plus 3 or 6-month DAPT (dual anti-platelet therapy)	Device: Drug Eluting Stent; Other Names: Xience/Promus, Resolute or Synergy

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Composite of cardiac death and myocardial infarction		12 months
Ischemia driven target lesion revascularization		12 months
Definite and probable stent thrombosis		12 months
BARC class 3-5 bleeding		6 months
TIMI major bleeding; TIMI major and minor bleeding		6 months
Acute Success Rates	Device success; Lesion success; Procedure success	procedure
Health economic utility	Total cardiovascular and bleeding related costs with cost effectiveness based on events avoided	12 months

Collaborators and Investigators

• Sponsor: CeloNova BioSciences, Inc.
• Investigators: Study Chair: Adnan Kastrati, ISAResearch Center Deutsches Herzzentrum München

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 5, 2016
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: October 30, 2015
• First Submitted That Met QC Criteria: October 30, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 23, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable; Angina, Unstable
• Other Study ID Numbers: COBRA 2015-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes