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Coronary Artery DiseasePhase 4SORT-OUT VNCT01254981

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

A Phase 4 study testing Percutaneous coronary intervention (PCI) in people with Coronary Artery Disease and Angina Pectoris, run by Aarhus University Hospital Skejby at 3 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Coronary Artery Disease, Angina Pectoris
What is being tested?
Percutaneous coronary intervention (PCI)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,504 participants
Where
3 sitesDenmark
Study dates
Jul 2009to Dec 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Denmark3 sites

  • Aalborg Universitetshospital

    Aalborg, 9000

  • Aarhus University Hospital, Skejby

    Aarhus N, 8200

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

About this study

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

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

Read the 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.

Being tested
Percutaneous coronary intervention (PCI)
Keywords
Percutaneous coronary intervention, DES, Angina pectoris, Stent
Medical subject headings
Coronary Artery Disease, Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous coronary intervention (PCI)Procedure or surgery

    Also called PCI, PTCA

    Implantation of coronary stent

Study groups in NCT01254981
Study groupRoleWhat they receive
NoboriExperimentalPercutaneous coronary intervention with implantation of coronary stent (Nobori)
Receives: Procedure: Percutaneous coronary intervention (PCI)
CypherExperimentalPercutaneous coronary intervention with implantation of coronary stent (Cypher)
Receives: Procedure: Percutaneous coronary intervention (PCI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Within 9 months

Secondary outcomes (6)

  1. 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

  2. Major Adverse Coronary Events

    Cardiac death, myocardial infarction, target vessel revascularisation: repeated revascularisation of an index lesion at PCI or bypass surgery

    Measured: 30 days

  3. Target lesion revascularisation defined as repeated revascularisation of an index lesion at PCI or bypass surgery.

    Measured: 9 and 12 months and 3 years

  4. Death

    Measured: 30 days and 9 months

  5. Acute Myocardial Infarction

    Measured: 30 days and 9 months

  6. Stent thrombosis

    Defined in accordance with the ARC definition of stent thrombosis

    Measured: 12, 24 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2010 (estimated)
  2. Study startJul 2009
  3. Primary completionJan 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,504 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01254981
Sponsor's protocol ID
M-20090103
Acronym
SORT-OUT V
Status last verified
Aug 2013
First submitted
6 Dec 2010
Last updated
29 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23374649

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Percutaneous coronary intervention (PCI) in people with Coronary Artery Disease and Angina Pectoris, run by Aarhus University Hospital Skejby at 3 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary outcome (time frame: Within 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01254981, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2013.

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