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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02594501
Recruitment Status : Recruiting
First Posted : November 3, 2015
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Angina, Stable Angina, Unstable Anticoagulants Device: COBRA PzF Device: Drug Eluting Stent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 996 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COBRA PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention
Study Start Date : February 5, 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

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 Name: Xience/Promus, Resolute or Synergy




Primary Outcome Measures :
  1. BARC class >=2 bleeding after hospital discharge [ Time Frame: 6 months ]
  2. Composite of all cause death, myocardial infarction, definite and probable stent thrombosis or ischemic stroke [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Composite of all cause death, myocardial infarction, definite and probable stent thrombosis, ischemia-driven target lesion revascularization or ischemic stroke [ Time Frame: 12 months ]
  2. Composite of cardiac death and myocardial infarction [ Time Frame: 12 months ]
  3. Ischemia driven target lesion revascularization [ Time Frame: 12 months ]
  4. Definite and probable stent thrombosis [ Time Frame: 12 months ]
  5. Ischemic stroke [ Time Frame: 12 months ]
  6. BARC class 3-5 bleeding [ Time Frame: 6 months ]
  7. TIMI major bleeding; TIMI major and minor bleeding [ Time Frame: 6 months ]
  8. Acute Success Rates [ Time Frame: procedure ]
    Device success; Lesion success; Procedure success

  9. Health economic utility [ Time Frame: 12 months ]
    Total cardiovascular and bleeding related costs with cost effectiveness based on events avoided



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594501


Contacts
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Contact: Dirk Pauwels +41 152 6588 4291 dpauwels@celonova.com
Contact: Diana Sanchez-Garcia dgarcia@celonova.com

  Hide Study Locations
Locations
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United States, California
Cedars Sinai Medical Center Withdrawn
Beverly Hills, California, United States, 90211
United States, Delaware
Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19718
United States, Florida
University of Florida Recruiting
Jacksonville, Florida, United States, 32209
Memorial Hospital Jacksonville Recruiting
Jacksonville, Florida, United States, 32216
Contact: Sumant Lamba, MD         
Sebastian River Medical Center Recruiting
Melbourne, Florida, United States, 32901
Mt Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
United States, Georgia
Augusta University Not yet recruiting
Augusta, Georgia, United States, 30912
United States, Maryland
University of Maryland St. Joseph Medical Center Recruiting
Towson, Maryland, United States, 21204
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
United States, Minnesota
Minneapolis Heart Institute Active, not recruiting
Minneapolis, Minnesota, United States, 55407
United States, New Jersey
Deborah Heart and Lung Center Recruiting
Browns Mills, New Jersey, United States, 08015
Rutgers Robert Wood Johnson Medical Schoo Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Bobby Gosh, MD         
United States, New York
Northwell Health Recruiting
Manhasset, New York, United States, 11030
NYU Winthrop Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Stephen Green, MD         
Mt Sinai Medical Center Withdrawn
New York, New York, United States, 10029
United States, Ohio
North Ohio Heart Center Recruiting
Elyria, Ohio, United States, 44035
Cleveland Clinic Recruiting
Fairview Park, Ohio, United States, 44126
Mercy St. Vincent Medical Center Recruiting
Toledo, Ohio, United States, 43608
United States, Pennsylvania
Geisinger Holy Spirit (Capital Area Research, LLC) Withdrawn
Camp Hill, Pennsylvania, United States, 17011
Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
United States, Texas
Baylor Heart and Vascular Hospital Withdrawn
Dallas, Texas, United States, 75226
Plaza Medical Center Withdrawn
Fort Worth, Texas, United States, 76104
Texas Cardiac Center Recruiting
Lubbock, Texas, United States, 79410
Tyler Cardiovascular Consultants Recruiting
Tyler, Texas, United States, 75701
United States, Virginia
Sentara Heart Hospital (Sentara Cardiovascular Research Institute) Recruiting
Norfolk, Virginia, United States, 23507
Carilion Medical Center Recruiting
Roanoke, Virginia, United States, 24014
Contact: Mohd Mirza, MD         
United States, West Virginia
Charleston Area Medical Center Recruiting
Charleston, West Virginia, United States, 25304
Belgium
ZNA Middelheim Recruiting
Antwerp, Belgium, 2020
Denmark
Aalborg Universitetshospital Withdrawn
Aalborg, Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark
France
Clinique Axium Recruiting
Aix, France
Clinique Du Pont De Chaumes Recruiting
Montauban, France
Clinique du Millénaire Recruiting
Montpellier, France, 34000
Contact: Christophe Piot         
Hopital Pitie-Salpitierre Recruiting
Paris, France, 75013
Contact: Gilles Montalescot         
Höpital George Pompidou Recruiting
Paris, France
Clinique St Hilaire Withdrawn
Rouen, France
Clinique Pasteur Not yet recruiting
Toulouse, France, 31300
Contact: Jean Fajadet         
Institut Lorrain du Coeur et Vaisseaux, CHU Nancy-Barbois Recruiting
Vandœuvre-lès-Nancy, France
Germany
Universitats Herzzentrum Freibourg Recruiting
Bad Krozingen, Germany, 79819
Contact: Christian Valina         
Charité - Campus Benjamin Franklin Recruiting
Berlin, Germany, 12203
Contact: David Lesitner         
Uni-Klinikum Erlangen Recruiting
Erlangen, Germany
St. Josefskrankenhaus Recruiting
Freiburg, Germany
Klinikum Fürth Recruiting
Fürth, Germany
Universitätsklinikum Gießen Withdrawn
Gießen, Germany
University of Jena Recruiting
Jena, Germany
MediClin Herzzentrum Recruiting
Lahr, Germany
Klinikum Landshut-Achdorf Recruiting
Landshut, Germany
Deutsches Herzzentrum München Recruiting
Munich, Germany
Klinikum Rechts der Isar München Recruiting
Munich, Germany
Universitätsklinikum Regensburg Recruiting
Regensburg, Germany
Hegau Bodensee Klinikum Singen Recruiting
Singen, Germany
Univesitätsklinikum Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Tobias Geisler         
Helios Herzzentrum Withdrawn
Wuppertal, Germany
Italy
Ospedale Spaziani Recruiting
Frosinone, Italy
Ospedale S. Eugenio Withdrawn
Rome, Italy
Latvia
Paula Stradins Clinical University Hospital Recruiting
Riga, Latvia, LV-1002
Switzerland
Universitätsspital Basel Withdrawn
Basel, Switzerland, 4031
Hopital Cantonal Fribourg Active, not recruiting
Fribourg, Switzerland
Kantonspital St Galen Active, not recruiting
St Gallen, Switzerland
Sponsors and Collaborators
CeloNova BioSciences, Inc.
Investigators
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Study Chair: Adnan Kastrati ISAResearch Center Deutsches Herzzentrum München

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Responsible Party: CeloNova BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT02594501     History of Changes
Other Study ID Numbers: COBRA 2015-01
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Chest Pain
Pain
Angina Pectoris
Angina, Unstable
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Neurologic Manifestations
Signs and Symptoms