Brief description of trial (Data source: BASEC)
Untersuchung ob Patienten unter Blutverdünnungstherapie von einer Angioplastie (Einsetzen eines Stents um die Verengung eines Herzkranzgefässes offen zu halten) mit einem Polyzene-F-Plymer-beschichtetem Stent und auf 14 Tage verkürzter dualer Plättchenhemmungstherapie verglichen mit Medikamente-freisetzenden Stents und standardgemässer 6 Monate dauernder dualer Plättchenhemmungstherapie profitieren.
Health conditions investigated(Data source: BASEC)
Patienten mit behandlungsbedürftiger koronarer Herzkrankheit, die aus anderen medizinischen Gründen orale Blutverdünnungsmedikamente einnehmen müssen.
Health conditions
(Data source: WHO)
Angina, Stable;Angina, Unstable;Anticoagulants
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Vergleich des Cobra-PzF-Stent mit 14 Tage dauernder dualer Plättchenhemmungstherapie gegenüber Medikamenten-beschichtetem Stent mit Standard-Therapie-Dauer der dualen Plättchenhemmung von 6 Monaten bei Patienten mit zusätzlicher oraler Blutverdünnung.
Interventions
(Data source: WHO)
Device: COBRA PzF;Device: Drug Eluting Stent
Criteria for participation in trial
(Data source: BASEC)
- >= 18 Jahre mit ischämischen Symptomen
- Einnahme von Blutverdünnungsmedikamenten
- schriftliche Studieneinwilligung
Exclusion criteria
(Data source: BASEC)
- Kardiogenischer Schock
- Hauptstammläsion
- Bifurkationsläsion mit 2-Stent Strategie
Inclusion/Exclusion Criteria
(Data source: WHO)
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
-
Further information on trial
Date trial registered
Oct 30, 2015
Incorporation of the first participant
Feb 5, 2016
Recruitment status
Active, not recruiting
Academic title
(Data source: WHO)
COBRA PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
BARC class >=2 bleeding after hospital discharge (or beyond 14 days, whichever is later).;Composite of all cause death, myocardial infarction, definite and probable stent thrombosis or ischemic stroke
Secundary end point
(Data source: WHO)
Composite of all cause death, myocardial infarction, definite and probable stent thrombosis, ischemia-driven target lesion revascularization or ischemic stroke;Composite of cardiac death and myocardial infarction;Ischemia driven target lesion revascularization;Definite and probable stent thrombosis;Ischemic stroke;BARC class 3-5 bleeding;TIMI major bleeding; TIMI major and minor bleeding;Acute Success Rates;Health economic utility
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
No
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Freiburg, St. Gallen
Countries
(Data source: WHO)
Belgium, Denmark, France, Germany, Italy, Latvia, Switzerland, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Dr. Daniel Weilenmann
+41 71 494 11 11
daniel.weilenmann@kssg.ch
Contact for general information
(Data source: WHO)
Adnan Kastrati
ISAResearch Center Deutsches Herzzentrum München
Contact for scientific information
(Data source: WHO)
Adnan Kastrati
ISAResearch Center Deutsches Herzzentrum München
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Ostschweiz (EKOS)
Date of authorisation by the ethics committee
24.05.2016
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-00712
Secondary ID (Data source: WHO)
COBRA 2015-01
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