SORT-OUT V - Randomised Clinical Comparative Study of the Nobori and the Cypher Stent.

Coronary Artery Disease Clinical Trial

— SORT-OUT V  

Official title:

Randomized Clinical Comparative Study of the Nobori and the Cypher Stents in Unselected Subjects With Ischemic Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254981
• Other study ID #: M-20090103
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2010
• Last updated: August 28, 2013
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2013
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

To perform a randomized comparison between the Cypher Select+ stent and the Nobori stent in the treatment of unselected patients with ischaemic heart disease.

Description:

All patients to be treated with one or several drug-eluting coronary stents at one of the four heart centers in Odense, Skejby, Aalborg and Varde can be included in the study. All patients enrolled in the study will be hospitalized at one of the heart centers mentioned. Patients will not be recruited via advertisements.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2504
• Est. completion date: December 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

All patients eligible for treatment with one or several drug-eluting coronary stents at one of the four heart centers in Odense, Skejby, Aalborg or Varde can be included in the study.

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 does not wish to participate

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Percutaneous coronary intervention (PCI)
Implantation of coronary stent

Locations

Country	Name	City	State
Denmark	Aalborg Universitetshospital	Aalborg
Denmark	Aarhus University Hospital, Skejby	Aarhus N
Denmark	Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Johnson & Johnson, Terumo Europe N.V.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome	Major Adverse Cardiac Events, such as cardiac death, myocardial infarction, stent thrombosis or target lesion revascularisation: repeated revascularisation of an index lesion at PCI or bypass surgery	Within 9 months	Yes
Secondary	Secondary outcome	Device success rate defined as the frequency of a successful implantation of the study stent in all the stenoses scheduled to be treated with residual stenosis < 20; Procedural success rate defined as the frequency of successful implantation of the study stent in all the stenoses scheduled to be treated with residual stenosis < 20% and without serious complications (MACE = Major Adverse Coronary Events)); Procedural time defined as time from guiding catheter in to guiding catheter out; X-ray time; Use of contrast medium		Yes
Secondary	Major Adverse Coronary Events	Cardiac death, myocardial infarction, target vessel revascularisation: repeated revascularisation of an index lesion at PCI or bypass surgery	30 days	Yes
Secondary	Target lesion revascularisation defined as repeated revascularisation of an index lesion at PCI or bypass surgery.		9 and 12 months and 3 years	Yes
Secondary	Death		30 days and 9 months	Yes
Secondary	Acute Myocardial Infarction		30 days and 9 months	Yes
Secondary	Stent thrombosis	Defined in accordance with the ARC definition of stent thrombosis	12, 24 and 36 months	Yes