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

This study is currently recruiting participants.
Verified October 2017 by CeloNova BioSciences, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02594501
First Posted: November 3, 2015
Last Update Posted: October 18, 2017
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.
Information provided by (Responsible Party):
CeloNova BioSciences, Inc.
  Purpose
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 Intervention
Angina, Stable Angina, Unstable Anticoagulants Device: COBRA PzF Device: Drug Eluting Stent

Study Type: Interventional
Study Design: 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

Further study details as provided by CeloNova BioSciences, Inc.:

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

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

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


Estimated Enrollment: 996
Study Start Date: February 5, 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
Contact: Dirk Pauwels +41 152 6588 4291 dpauwels@celonova.com
Contact: Elke Haun Haun@dhm.mhn.de

  Show 45 Study Locations
Sponsors and Collaborators
CeloNova BioSciences, Inc.
Investigators
Study Chair: Adnan Kastrati ISAResearch Center Deutsches Herzzentrum München
  More Information

Responsible Party: CeloNova BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT02594501     History of Changes
Other Study ID Numbers: COBRA 2015-01
First Submitted: October 30, 2015
First Posted: November 3, 2015
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Angina Pectoris
Angina, Unstable
Angina, Stable
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms