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

This study has been completed.
Sponsor:
Collaborators:
Terumo Europe N.V.
Johnson & Johnson
Information provided by (Responsible Party):
Evald Hoej Christiansen, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT01254981
First received: December 6, 2010
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Angina Pectoris
Procedure: Percutaneous coronary intervention (PCI)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Comparative Study of the Nobori and the Cypher Stents in Unselected Subjects With Ischemic Heart Disease

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • Primary outcome [ Time Frame: Within 9 months ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Secondary outcome [ Designated as safety issue: Yes ]
    • 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

  • Major Adverse Coronary Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Cardiac death, myocardial infarction, target vessel revascularisation: repeated revascularisation of an index lesion at PCI or bypass surgery

  • Target lesion revascularisation defined as repeated revascularisation of an index lesion at PCI or bypass surgery. [ Time Frame: 9 and 12 months and 3 years ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 30 days and 9 months ] [ Designated as safety issue: Yes ]
  • Acute Myocardial Infarction [ Time Frame: 30 days and 9 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Defined in accordance with the ARC definition of stent thrombosis


Enrollment: 2504
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nobori
Percutaneous coronary intervention with implantation of coronary stent (Nobori)
Procedure: Percutaneous coronary intervention (PCI)
Implantation of coronary stent
Other Names:
  • PCI
  • PTCA
Experimental: Cypher
Percutaneous coronary intervention with implantation of coronary stent (Cypher)
Procedure: Percutaneous coronary intervention (PCI)
Implantation of coronary stent
Other Names:
  • PCI
  • PTCA

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01254981

Locations
Denmark
Aalborg Universitetshospital
Aalborg, Denmark, 9000
Aarhus University Hospital, Skejby
Aarhus N, Denmark, 8200
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Aarhus University Hospital Skejby
Terumo Europe N.V.
Johnson & Johnson
Investigators
Principal Investigator: Evald H Christiansen, MD Aarhus University Hospital Skejby
  More Information

No publications provided by Aarhus University Hospital Skejby

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Evald Hoej Christiansen, MD. DMSc, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT01254981     History of Changes
Other Study ID Numbers: M-20090103
Study First Received: December 6, 2010
Last Updated: August 28, 2013
Health Authority: Denmark: National Board of Health

Keywords provided by Aarhus University Hospital Skejby:
Percutaneous coronary intervention
DES
Angina pectoris
Stent

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 01, 2014