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SNCTP000001901 | NCT02594501 | BASEC2016-00712

Verkürzung der Dauer der Triple Therapie mit Hilfe des Cobra PzF Stents bei Patienten mit oraler Antikoagulation, die mit einer perkutanen Koronarintervention und zugelassenen Koronar-Stents behandelt wurden.

Data source: BASEC (Imported from 29.03.2024), WHO (Imported from 29.03.2024)
Changed: Dec 23, 2023, 4:31 PM
Disease category: Coronary Heart disease

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 the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02594501

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02594501
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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