Coronary Artery DiseaseMODEL U-SESNCT02837003
3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation
An observational study of Coronary Artery Disease, run by Teikyo University at 1 site in Japan.
Trial summary
To evaluate safety of reduction of dual antiplatelet therapy period to three months after implantation of Ultimaster sirolimus-eluting stent (U-SES). Additionally to investigate appropriateness of thienopyridine monotherapy with discontinuation of aspirin. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Aspirin and Thienopyridine
- How many people
- 1,500 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2016to Mar 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The present study consisted of the following two study arms: the 3-month DAPT arm, a new registry arm in which 1,500 patients are consecutively recruite at 72 medical institutions; and the Longer DAPT arm, a historical control arm that consisted of 1,123 patients at 58 medical institutions.
Who may be able to join
- Patients with coronary artery lesion who received percutaneous coronary intervention using Ultimaster sirolimus-eluting stent.
- Patients considered appropriate to discontinue dual antiplatelet therapy at 3 months after stent implantation.
- Patients who have provided written informed consent.
Who cannot join
- Patients previously experienced stent thrombosis.
- Patients who are unable to clinical follow-up procedure specified in the protocal for the present study.
- Patients who are enrolled or planned to participate in another clinical trials of antiplatelet therapy.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Teikyo University Hospital
Tokyo, 173-8606
Ken Kozuma, MD, PhD, +81-3-3964-1211, PXE00364@nifty.com
About this study
To evaluate safety of reduction of dual antiplatelet therapy period to three months after implantation of Ultimaster sirolimus-eluting stent (U-SES).
Additionally to investigate appropriateness of thienopyridine monotherapy with discontinuation of aspirin.
- Conditions
- Coronary Artery Disease
- Being tested
- Aspirin, Thienopyridine
- Keywords
- Drug-Eluting Stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Discontinuation of aspirin at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.
ThienopyridineDrug
Discontinuation of thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Aspirin | Aspirin treatment for 3 months after the Ultimaster sirolimus-eluting stent implantation. Receives: Drug: Aspirin | |
| Experimental: Thienopyridine | Thienopyridine treatment for 3 months after the Ultimaster sirolimus-eluting Stent implantation. Receives: Drug: Thienopyridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of all cause death in 12 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5).
Measured: 12-month
Secondary outcomes (22)
Composite endpoint of all cause death in 3 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5).
Measured: 3-month
Major adverse cardiac event
Measured: 3-month
Major adverse cardiac event
Measured: 12-month
All cause death
Measured: 3-month
All cause death
Measured: 12-month
Cardiac death
Measured: 3-month
Cardiac death
Measured: 12-month
Myocardial infarction
Measured: 3-month
Myocardial infarction
Measured: 12-month
Stroke (ischemic and hemorrhagic)
Measured: 3-month
Stroke (ischemic and hemorrhagic)
Measured: 12-month
Target lesion revascularization
Measured: 3-month
Target lesion revascularization
Measured: 12-month
Target vessel revascularization
Measured: 3-month
Target vessel revascularization
Measured: 12-month
Readmission related to angina
Measured: 3-month
Readmission related to angina
Measured: 12-month
Stent thrombosis
Measured: 3-month
Stent thrombosis (ARC definition)
Measured: 12-month
Bleeding complications (BARC definition)
Measured: 3-month
Bleeding complications (BARC definition)
Measured: 12-month
Comparison of event rate by the type of antiplatelet agent
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Teikyo University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ken Kozuma, MD, PhD, Principal investigator, Teikyo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837003
- Sponsor's protocol ID
- MODEL U-SES
- Acronym
- MODEL U-SES
- Status last verified
- Jul 2016
- First submitted
- 8 Jul 2016
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation
- ClinicalTrials.gov ID
- NCT02837003
- Acronym / sponsor ID
- MODEL U-SES / MODEL U-SES
- Conditions
- Coronary Artery Disease
- Keywords
- Drug-Eluting Stent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Teikyo UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 19 Jul 2016 (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.
To evaluate safety of reduction of dual antiplatelet therapy period to three months after implantation of Ultimaster sirolimus-eluting stent (U-SES).
Additionally to investigate appropriateness of thienopyridine monotherapy with discontinuation of aspirin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Aspirin | – | Drug: AspirinAspirin treatment for 3 months after the Ultimaster sirolimus-eluting stent implantation. |
| Experimental: Thienopyridine | – | Drug: ThienopyridineThienopyridine treatment for 3 months after the Ultimaster sirolimus-eluting Stent implantation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The present study consisted of the following two study arms: the 3-month DAPT arm, a new registry arm in which 1,500 patients are consecutively recruite at 72 medical institutions; and the Longer DAPT arm, a historical control arm that consisted of 1,123 patients at 58 medical institutions.
Key inclusion criteria (3 listed)
- Patients with coronary artery lesion who received percutaneous coronary intervention using Ultimaster sirolimus-eluting stent.
- Patients considered appropriate to discontinue dual antiplatelet therapy at 3 months after stent implantation.
- Patients who have provided written informed consent.
Key exclusion criteria (3 listed)
- Patients previously experienced stent thrombosis.
- Patients who are unable to clinical follow-up procedure specified in the protocal for the present study.
- Patients who are enrolled or planned to participate in another clinical trials of antiplatelet therapy.
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 |
|---|---|---|
| AspirinDiscontinuation of aspirin at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion. | Drug | Experimental: Aspirin |
| ThienopyridineDiscontinuation of thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion. | Drug | Experimental: Thienopyridine |
Primary outcome
Composite endpoint of all cause death in 12 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5).
Time frame: 12-month
22 secondary outcomes
Composite endpoint of all cause death in 3 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5).
Time frame: 3-month
Major adverse cardiac event
Time frame: 3-month
Major adverse cardiac event
Time frame: 12-month
All cause death
Time frame: 3-month
All cause death
Time frame: 12-month
Cardiac death
Time frame: 3-month
Cardiac death
Time frame: 12-month
Myocardial infarction
Time frame: 3-month
Myocardial infarction
Time frame: 12-month
Stroke (ischemic and hemorrhagic)
Time frame: 3-month
Stroke (ischemic and hemorrhagic)
Time frame: 12-month
Target lesion revascularization
Time frame: 3-month
Target lesion revascularization
Time frame: 12-month
Target vessel revascularization
Time frame: 3-month
Target vessel revascularization
Time frame: 12-month
Readmission related to angina
Time frame: 3-month
Readmission related to angina
Time frame: 12-month
Stent thrombosis
Time frame: 3-month
Stent thrombosis (ARC definition)
Time frame: 12-month
Bleeding complications (BARC definition)
Time frame: 3-month
Bleeding complications (BARC definition)
Time frame: 12-month
Comparison of event rate by the type of antiplatelet agent
Time frame: 12-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
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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.
Ken Kozuma, MD, PhD principal investigator
Teikyo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Teikyo University at 1 site in Japan.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ken Kozuma, MD, PhD (+81-3-3964-1211, PXE00364@nifty.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of all cause death in 12 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5). (time frame: 12-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2016.