SORT-OUT V - Randomised Clinical Comparative Study of the Nobori and the Cypher Stent.
NCT ID: NCT01254981
Last Updated: 2013-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
2504 participants
INTERVENTIONAL
2009-07-31
2011-12-31
Brief Summary
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Detailed Description
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The study is designed as a non-inferiority study, where the objective is to prove that Nobori is Δ0 poorer as a maximum than Cypher select+. The nine-month event rate (cardiac death, MI and/or TVR) in the Cypher stent group of SORT OUT 3 was 3.0%
The calculation of power below has been made under the following assumptions:
P (Cypher) = 0.03
There is no good estimate for the event rate related to the Nobori stent. α = 0.05 - one-sided
1-β = 0.80
Based on the various values of Δ0 the necessary number of patients, N, in each group can be calculated (StudySize Version 2.0.4, Creostat):
* Δ0 \*N in each group
* 0.0025 \*57,589
* 0.005 \*14,397
* 0.010 \*3,599
* 0.015 \*1,599
* 0.020 \*900
According to the above assumptions, a total of 900 patients must be included in each group in order to reject a null hypothesis that the event rate in the Nobori group is more than 2 percentage points (0.02) poorer than the event rate in the Cypher group or that Nobori is inferior to Cypher, (H0: pNobori - pCypher ≥ Δ0 = 0.02). The alternative hypothesis (HA: pN - pS \< Δ0) provides that Nobori is non-inferior to Cypher - with the selected limit for non-inferiority.
Assuming an inclusion rate of 200 patients per month, it will be possible to include 2000 patients in 10 months.
Power is almost 0.9 if the inclusion is increased to a little over 2400.
Organization
The study is headed by a steering committee, in which PCI operators will participate from each of the participating sites.
Evald Høj Christiansen, Aarhus, will be Principal Investigator. At present, the other members of the steering committee are: Jens Flensted Lassen (chairman), Leif Thuesen, Jan Ravkilde, Hans-Henrik Tilsted, Per Thayssen and Lisette Okkels Jensen. All members of the steering committee will be given full access to the database and will take part in the interpretation of data.
The study secretariat and the randomization computer are localized at the Department of Cardiology, \[Hjertemedicinsk Afdeling\], Aarhus University Hospital, Skejby.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nobori
Percutaneous coronary intervention with implantation of coronary stent (Nobori)
Percutaneous coronary intervention (PCI)
Implantation of coronary stent
Cypher
Percutaneous coronary intervention with implantation of coronary stent (Cypher)
Percutaneous coronary intervention (PCI)
Implantation of coronary stent
Interventions
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Percutaneous coronary intervention (PCI)
Implantation of coronary stent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
The patients will be treated in accordance with the criteria applicable at the individual sites. The indication for using DES varies slightly between the four sites, as the indication for implantation of DES is based on clinical and angiographic criteria with the financial constraints applying at the individual site. Basically, DES will be chosen instead of BMS in patients with an estimated increased risk of restenosis, in patients with the following stenosis types: Long lesions, lesions in small vessels, bifurcations, ostial lesions, in-stent restenoses and stenosis in the proximal segment of the anterior descending branch. Furthermore, DES will also be chosen for diabetics and in the left main.
Exclusion Criteria
* The patient is participating in other randomized stent studies
* Life expectancy \< 1 year
* Allergic to Aspirin, clopidogrel, prasugrel or ticlopidin
* Allergic to sirolimus or biolimus
ALL
No
Sponsors
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Terumo Europe N.V.
INDUSTRY
Johnson & Johnson
INDUSTRY
Aarhus University Hospital Skejby
OTHER
Responsible Party
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Evald Hoej Christiansen
MD. DMSc
Principal Investigators
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Evald H Christiansen, MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital Skejby
Locations
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Aalborg Universitetshospital
Aalborg, , Denmark
Aarhus University Hospital, Skejby
Aarhus N, , Denmark
Odense University Hospital
Odense, , Denmark
Countries
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References
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Christiansen EH, Jensen LO, Thayssen P, Tilsted HH, Krusell LR, Hansen KN, Kaltoft A, Maeng M, Kristensen SD, Botker HE, Terkelsen CJ, Villadsen AB, Ravkilde J, Aaroe J, Madsen M, Thuesen L, Lassen JF; Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) V investigators. Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial. Lancet. 2013 Feb 23;381(9867):661-9. doi: 10.1016/S0140-6736(12)61962-X. Epub 2013 Jan 30.
Other Identifiers
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M-20090103
Identifier Type: -
Identifier Source: org_study_id