Coronary Artery DiseasePhase 4SORT-OUTIINCT00388934
Comparison of Cypher Select and Taxus Express Coronary Stents
A Phase 4 study testing Drug eluting stent in people with Coronary Artery Disease and Angina Pectoris, run by Aarhus University Hospital Skejby.
Trial summary
Randomized nine months clinical comparison of implantation of Taxol eluting (Taxus Express) and Sirolimus eluting (Cypher Select) stents in non-selected patients with coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Angina Pectoris
- What is being tested?
- Drug eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,095 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Jan 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned implantation of drug eluting stent
- Written informed consent
Who cannot join
- Planned intervention with other stents than study stents
About this study
Official title: Randomized Clinical Comparison of Cypher Select and Taxus Express Stent Implantation in Unselected Patients With Coronary Artery Disease.
Randomized nine months clinical comparison of implantation of Taxol eluting (Taxus Express) and Sirolimus eluting (Cypher Select) stents in non-selected patients with coronary artery disease.
Read the detailed description
Design:
- Randomized open multicentre trial.
Patients:
- 1800 patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation.
Inclusion criteria:
- Patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation.
- Signed informed consent.
Exclusion criteria:
- Participation in other stent studies.
Randomization:
- Implantation of Taxus Express og Cypher Select stents.
Primary end-point:
- Combined end-point of cardiac death, new revascularization (PCI or CABG) or myocardial infarction after nine months.
Secondary end-points:
- Total death after nine months
- Cardiac death after nine months
- Myocardial infarction after nine months
- Index vessel myocardial infarction after nine months
- Target lesion revascularization
- Target vessel revascularization
- Stent thrombosis after nine months
End-point evaluation:
- End-points will be adjudicated by an independent end-point committee
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Being tested
- Drug eluting stent
- Keywords
- Percutaneous coronary intervention, 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.
Drug eluting stentDevice
Also called DES, Cypher, Taxus
percutaneous intervention with implantation of drug eluting coronary stent
| Study group | Role | What they receive |
|---|---|---|
| Drug eluting stent (Cypher) | Experimental | Percutaneous coronary intervention with implantation of drug eluting coronary stent (Cypher) Receives: Device: Drug eluting stent |
| Drug eluting stent (Taxus) | Experimental | Percutaneous coronary intervention with implantation of drug eluting coronary stent (Taxus) Receives: Device: Drug eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF)
Measured: during 9 months
Secondary outcomes (5)
Total death
Measured: after 9 months, 2 and 3 years
Cardiac death
Measured: after 9 months, 2 and 3 years
Myocardial infarction
Measured: after 9 months, 2 and 3 years
Target vessel revascularisation, target lesion revascularisation, TVF
Measured: after 9 months, 2 and 3 years
Stent thrombosis
Measured: after 9 months, 2 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study startAug 2004
- Primary completionJan 2006
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 2,095 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Investigators
- Anders Galloe, MD, Principal investigator, Gentofte Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388934
- Sponsor's protocol ID
- SORT-OUT II
- Acronym
- SORT-OUTII
- Status last verified
- May 2007
- First submitted
- 16 Oct 2006
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Galloe AM, Kelbaek H, Thuesen L, Hansen HS, Ravkilde J, Hansen PR, Christiansen EH, Abildgaard U, Stephansen G, Lassen JF, Engstrom T, Jensen JS, Jeppesen JL, Bligaard N; SORT OUT II Investigators. 10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents. J Am Coll Cardiol. 2017 Feb 14;69(6):616-624. doi: 10.1016/j.jacc.2016.11.055.
PubMed 28183505Galloe AM, Thuesen L, Kelbaek H, Thayssen P, Rasmussen K, Hansen PR, Bligaard N, Saunamaki K, Junker A, Aaroe J, Abildgaard U, Ravkilde J, Engstrom T, Jensen JS, Andersen HR, Botker HE, Galatius S, Kristensen SD, Madsen JK, Krusell LR, Abildstrom SZ, Stephansen GB, Lassen JF; SORT OUT II Investigators. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA. 2008 Jan 30;299(4):409-16. doi: 10.1001/jama.299.4.409.
PubMed 18230778
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Comparison of Cypher Select and Taxus Express Stent Implantation in Unselected Patients With Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT00388934
- Acronym / sponsor ID
- SORT-OUTII / SORT-OUT II
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Keywords
- Percutaneous coronary intervention, Angina pectoris, Stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,095 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- University of Aarhus, University of Copenhagen, Odense University Hospital
- Study start
- Aug 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 17 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized nine months clinical comparison of implantation of Taxol eluting (Taxus Express) and Sirolimus eluting (Cypher Select) stents in non-selected patients with coronary artery disease.
Detailed description
Design:
- Randomized open multicentre trial.
Patients:
- 1800 patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation.
Inclusion criteria:
- Patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation.
- Signed informed consent.
Exclusion criteria:
- Participation in other stent studies.
Randomization:
- Implantation of Taxus Express og Cypher Select stents.
Primary end-point:
- Combined end-point of cardiac death, new revascularization (PCI or CABG) or myocardial infarction after nine months.
Secondary end-points:
- Total death after nine months
- Cardiac death after nine months
- Myocardial infarction after nine months
- Index vessel myocardial infarction after nine months
- Target lesion revascularization
- Target vessel revascularization
- Stent thrombosis after nine months
End-point evaluation:
- End-points will be adjudicated by an independent end-point committee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug eluting stent (Cypher) | Experimental | Device: Drug eluting stentPercutaneous coronary intervention with implantation of drug eluting coronary stent (Cypher) |
| Drug eluting stent (Taxus) | Experimental | Device: Drug eluting stentPercutaneous coronary intervention with implantation of drug eluting coronary stent (Taxus) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned implantation of drug eluting stent
- Written informed consent
Key exclusion criteria (1 listed)
- Planned intervention with other stents than study stents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug eluting stentAlso: DES, Cypher, Taxuspercutaneous intervention with implantation of drug eluting coronary stent | Device | Drug eluting stent (Cypher), Drug eluting stent (Taxus) |
Primary outcome
MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF)
Time frame: during 9 months
5 secondary outcomes
Total death
Time frame: after 9 months, 2 and 3 years
Cardiac death
Time frame: after 9 months, 2 and 3 years
Myocardial infarction
Time frame: after 9 months, 2 and 3 years
Target vessel revascularisation, target lesion revascularisation, TVF
Time frame: after 9 months, 2 and 3 years
Stent thrombosis
Time frame: after 9 months, 2 and 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
- Derived from this study: PubMed 28183505Galloe AM, Kelbaek H, Thuesen L, Hansen HS, Ravkilde J, Hansen PR, Christiansen EH, Abildgaard U, Stephansen G, Lassen JF, Engstrom T, Jensen JS, Jeppesen JL, Bligaard N; SORT OUT II Investigators. 10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents. J Am Coll Cardiol. 2017 Feb 14;69(6):616-624. doi: 10.1016/j.jacc.2016.11.055.
- Derived from this study: PubMed 18230778Galloe AM, Thuesen L, Kelbaek H, Thayssen P, Rasmussen K, Hansen PR, Bligaard N, Saunamaki K, Junker A, Aaroe J, Abildgaard U, Ravkilde J, Engstrom T, Jensen JS, Andersen HR, Botker HE, Galatius S, Kristensen SD, Madsen JK, Krusell LR, Abildstrom SZ, Stephansen GB, Lassen JF; SORT OUT II Investigators. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA. 2008 Jan 30;299(4):409-16. doi: 10.1001/jama.299.4.409.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Galloe, MD principal investigator
Gentofte Hospital, Copenhagen
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Drug eluting stent in people with Coronary Artery Disease and Angina Pectoris, run by Aarhus University Hospital Skejby.
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 1 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 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF) (time frame: during 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 NCT00388934, which also lists 2 linked publications.
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 30 Jul 2013.