Trial record 1 of 7 for:
COBRA REDUCE
Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy (COBRA-REDUCE)
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| ClinicalTrials.gov Identifier: NCT02594501 |
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Recruitment Status : Unknown
Verified October 2020 by CeloNova BioSciences, Inc..
Recruitment status was: Active, not recruiting
First Posted : November 3, 2015
Last Update Posted : October 26, 2020
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Sponsor:
CeloNova BioSciences, Inc.
Information provided by (Responsible Party):
CeloNova BioSciences, Inc.
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Actual 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 : | May 2021 |
| Estimated Study Completion Date : | November 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: COBRA PzF
Cobra PzF plus 14-day DAPT (dual antiplatelet therapy)
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Device: COBRA PzF |
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Active Comparator: Drug Eluting Stent
standard FDA-approved DES (Xience/Promus or Resolute) plus 3 or 6-month DAPT (dual anti-platelet therapy)
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Device: Drug Eluting Stent
Other Name: Xience/Promus, Resolute or Synergy |
Primary Outcome Measures :
- BARC class >=2 bleeding after hospital discharge (or beyond 14 days, whichever is "later"). [ 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
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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
Locations
Show 48 study locations
Sponsors and Collaborators
CeloNova BioSciences, Inc.
Investigators
| Study Chair: | Adnan Kastrati | ISAResearch Center Deutsches Herzzentrum München |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | CeloNova BioSciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT02594501 |
| Other Study ID Numbers: |
COBRA 2015-01 |
| First Posted: | November 3, 2015 Key Record Dates |
| Last Update Posted: | October 26, 2020 |
| Last Verified: | October 2020 |
| 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 |
Additional relevant MeSH terms:
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Angina Pectoris Angina, Unstable Angina, Stable Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Vascular Diseases Chest Pain Pain Neurologic Manifestations |