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

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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.

Tracking Information
First Submitted Date  ICMJE October 30, 2015
First Posted Date  ICMJE November 3, 2015
Last Update Posted Date December 14, 2018
Study Start Date  ICMJE February 5, 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2015)
BARC class >=2 bleeding after hospital discharge [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT02594501 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2015)
  • Composite of death, myocardial infarction, definite 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 ]
  • Target lesion revascularization [ Time Frame: 12 months ]
  • Definite 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy
Official Title  ICMJE COBRA PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Angina, Stable
  • Angina, Unstable
  • Anticoagulants
Intervention  ICMJE
  • Device: COBRA PzF
  • Device: Drug Eluting Stent
    Other Name: Xience/Promus, Resolute or Synergy
Study Arms  ICMJE
  • Experimental: COBRA PzF
    Cobra PzF plus 14-day DAPT (dual antiplatelet therapy)
    Intervention: 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)
    Intervention: Device: Drug Eluting Stent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 16, 2017)
996
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2015)
840
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dirk Pauwels +41 152 6588 4291 dpauwels@celonova.com
Contact: Diana Sanchez-Garcia dgarcia@celonova.com
Listed Location Countries  ICMJE Belgium,   Denmark,   France,   Germany,   Italy,   Latvia,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02594501
Other Study ID Numbers  ICMJE COBRA 2015-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CeloNova BioSciences, Inc.
Study Sponsor  ICMJE CeloNova BioSciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Adnan Kastrati ISAResearch Center Deutsches Herzzentrum München
PRS Account CeloNova BioSciences, Inc.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP