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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by CeloNova BioSciences, Inc.
Sponsor:
Information provided by (Responsible Party):
CeloNova BioSciences, Inc.
ClinicalTrials.gov Identifier:
NCT02594501
First received: October 30, 2015
Last updated: June 6, 2017
Last verified: June 2017
  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 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 ]
  • BARC class 3-5 bleeding or death [ Time Frame: 6 months ]
  • TIMI major bleeding [ Time Frame: 6 months ]
  • TIMI major and minor bleeding [ Time Frame: 6 months ]
  • Health economic utility [ Time Frame: 12 months ]
    Total cardiovascular and bleeding related costs with cost effectiveness based on events avoided


Estimated Enrollment: 844
Study Start Date: February 2016
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: April 2018 (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 6-month DAPT (dual anti-platelet therapy)
Device: Drug Eluting Stent
Other Name: Xience/Promus, Resolute or Synergy

  Eligibility

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

Inclusion Criteria:

  • Ischemic symptoms (stable or unstable angina) or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02594501

Contacts
Contact: Dirk Pauwels +41 152 6588 4291 dpauwels@celonova.com
Contact: Deborah-Ann Schuster schuster@dhm.mhn.de

  Show 30 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
Study First Received: October 30, 2015
Last Updated: June 6, 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

ClinicalTrials.gov processed this record on September 19, 2017