Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02594501
• Date of registration: 30/10/2015
• Prospective Registration: Yes
• Primary sponsor: CeloNova BioSciences, Inc.
• Public title: Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy COBRA-REDUCE
• Scientific title: COBRA PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention
• Date of first enrolment: February 5, 2016
• Target sample size: 996
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02594501
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belgium, Denmark, France, Germany, Italy, Latvia, Switzerland, United States

Contacts

• Name: Adnan Kastrati
• Affiliation: ISAResearch Center Deutsches Herzzentrum München

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Angina, Unstable

Anticoagulants

Angina, Stable

Intervention(s)

Device: COBRA PzF

Device: Drug Eluting Stent

Primary Outcome(s)

Composite of all cause death, myocardial infarction, definite and probable stent thrombosis or ischemic stroke [Time Frame: 6 months]

BARC class >=2 bleeding after hospital discharge (or beyond 14 days, whichever is "later"). [Time Frame: 6 months]

Secondary Outcome(s)

BARC class 3-5 bleeding [Time Frame: 6 months]

Ischemia driven target lesion revascularization [Time Frame: 12 months]

Composite of cardiac death and myocardial infarction [Time Frame: 12 months]

Composite of all cause death, myocardial infarction, definite and probable stent thrombosis, ischemia-driven target lesion revascularization or ischemic stroke [Time Frame: 12 months]

Health economic utility [Time Frame: 12 months]

Ischemic stroke [Time Frame: 12 months]

TIMI major bleeding; TIMI major and minor bleeding [Time Frame: 6 months]

Acute Success Rates [Time Frame: procedure]

Definite and probable stent thrombosis [Time Frame: 12 months]

Secondary ID(s)

COBRA 2015-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors