Coronary Artery DiseasePhase 4NCT01514227
Nobori Dual Antiplatelet Therapy as Appropriate Duration
A Phase 4 study testing Aspirin or thienopyridine and Aspirin and thienopyridine in people with Coronary Artery Disease, run by Associations for Establishment of Evidence in Interventions at 1 site in Japan.
Trial summary
NIPPON trial is a prospective, randomized, trial comparing 6 and 18 months Dual Antiplatelet Therapy (DAPT) following Nobori stent deployment. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Aspirin or thienopyridine and Aspirin and thienopyridine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,773 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2011to Jun 2016
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects > 20 years old
- Undergoing percutaneous intervention with Nobori deployment
- No contraindication to prolonged DAPT
Who cannot join
- Subjects absolutely necessitating continuous DAPT
- Planned surgery necessitating discontinuation of antiplatelet therapy after enrollment.
- Active pathological bleeding
- Status of cardiogenic shock at enrollment
- Pregnant women
- Life expectancy of < 1.5 years
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- Subjects unable to give informed consent
- Episode of stroke < 6 months
- Subjects with allergies or hypersensitivity to material of coating, Biolimus A9, and antiplatelet drugs.
- Subjects treated with other kind of DES or BMS during the index procedure
- Previous intervention with DES < 6 months.
- Study participation impractical per investigator judgment
Trial locations and contacts
1 site in 1 country.
Japan1 site
Non-profit organization Associations for Establishment of Evidence in Interventions
Minato-ku, Tokyo, 105-0013
About this study
Official title: Nobori Dual Antiplatelet Therapy as Appropriate Duration.
NIPPON trial is a prospective, randomized, trial comparing 6 and 18 months Dual Antiplatelet Therapy (DAPT) following Nobori stent deployment.
- Conditions
- Coronary Artery Disease
- Being tested
- Aspirin or thienopyridine, Aspirin and thienopyridine
- 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.
Aspirin or thienopyridineDrug
Subjects randomized 6 month DAPT will be prescribed either aspirin or thienopyridine (clopidogrel or ticlopidine) following 6 months DAPT for the duration of study, which is left on the physician's discretion.
Aspirin and thienopyridineDrug
Subjects randomized 18 month DAPT will be prescribed both aspirin and thienopyridine (clopidogrel or ticlopidine) for 18 month after stenting.
| Study group | Role | What they receive |
|---|---|---|
| Short-term DAPT (6 months) group | Experimental | 6 months DAPT (aspirin and thienopyridine) prescription following Nobori stent Receives: Drug: Aspirin or thienopyridine |
| Long-term DAPT (18 months) group | Experimental | 18 months DAPT (aspirin and thienopyridine) prescription following Nobori stent Receives: Drug: Aspirin and thienopyridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net adverse clinical and cerebral event (NACCE)
NACCE include all-cause death, non-fatal myocardial infarction, cerebrovascular events, and major bleeding.
Measured: 18 months
Secondary outcomes (6)
All-cause death
Measured: 18 months
Non-fatal myocardial infarction
Measured: 18 months
Cerebrovascular events
Measured: 18 months
Major bleeding
Measured: 18 months
Rate of target lesion revascularization
Measured: 18 months
Minor bleeding
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,773 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associations for Establishment of Evidence in Interventions
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514227
- Sponsor's protocol ID
- NIPPON 5.0
- Status last verified
- Jan 2017
- First submitted
- 22 Dec 2011
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nakamura M, Iijima R, Ako J, Shinke T, Okada H, Ito Y, Ando K, Anzai H, Tanaka H, Ueda Y, Takiuchi S, Nishida Y, Ohira H, Kawaguchi K, Kadotani M, Niinuma H, Omiya K, Morita T, Zen K, Yasaka Y, Inoue K, Ishiwata S, Ochiai M, Hamasaki T, Yokoi H; NIPPON Investigators. Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation. JACC Cardiovasc Interv. 2017 Jun 26;10(12):1189-1198. doi: 10.1016/j.jcin.2017.04.019.
PubMed 28641838
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nobori Dual Antiplatelet Therapy as Appropriate Duration.
- ClinicalTrials.gov ID
- NCT01514227
- Acronym / sponsor ID
- NIPPON 5.0
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,773 participants (actual)
- Lead sponsor
- Associations for Establishment of Evidence in InterventionsUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 Jan 2012 (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.
NIPPON trial is a prospective, randomized, trial comparing 6 and 18 months Dual Antiplatelet Therapy (DAPT) following Nobori stent deployment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-term DAPT (6 months) group | Experimental | Drug: Aspirin or thienopyridine6 months DAPT (aspirin and thienopyridine) prescription following Nobori stent |
| Long-term DAPT (18 months) group | Experimental | Drug: Aspirin and thienopyridine18 months DAPT (aspirin and thienopyridine) prescription following Nobori stent |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects > 20 years old
- Undergoing percutaneous intervention with Nobori deployment
- No contraindication to prolonged DAPT
Key exclusion criteria (12 listed)
- Subjects absolutely necessitating continuous DAPT
- Planned surgery necessitating discontinuation of antiplatelet therapy after enrollment.
- Active pathological bleeding
- Status of cardiogenic shock at enrollment
- Pregnant women
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 |
|---|---|---|
| Aspirin or thienopyridineSubjects randomized 6 month DAPT will be prescribed either aspirin or thienopyridine (clopidogrel or ticlopidine) following 6 months DAPT for the duration of study, which is left on the physician's discretion. | Drug | Short-term DAPT (6 months) group |
| Aspirin and thienopyridineSubjects randomized 18 month DAPT will be prescribed both aspirin and thienopyridine (clopidogrel or ticlopidine) for 18 month after stenting. | Drug | Long-term DAPT (18 months) group |
Primary outcome
Net adverse clinical and cerebral event (NACCE)
Time frame: 18 months
NACCE include all-cause death, non-fatal myocardial infarction, cerebrovascular events, and major bleeding.
6 secondary outcomes
All-cause death
Time frame: 18 months
Non-fatal myocardial infarction
Time frame: 18 months
Cerebrovascular events
Time frame: 18 months
Major bleeding
Time frame: 18 months
Rate of target lesion revascularization
Time frame: 18 months
Minor bleeding
Time frame: 18 months
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 27 Jan 2017.
- Derived from this study: PubMed 28641838Nakamura M, Iijima R, Ako J, Shinke T, Okada H, Ito Y, Ando K, Anzai H, Tanaka H, Ueda Y, Takiuchi S, Nishida Y, Ohira H, Kawaguchi K, Kadotani M, Niinuma H, Omiya K, Morita T, Zen K, Yasaka Y, Inoue K, Ishiwata S, Ochiai M, Hamasaki T, Yokoi H; NIPPON Investigators. Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation. JACC Cardiovasc Interv. 2017 Jun 26;10(12):1189-1198. doi: 10.1016/j.jcin.2017.04.019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin or thienopyridine and Aspirin and thienopyridine in people with Coronary Artery Disease, run by Associations for Establishment of Evidence in Interventions 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 12 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 27 Jan 2017. 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.
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?
Net adverse clinical and cerebral event (NACCE) (time frame: 18 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 NCT01514227, 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 27 Jan 2017.