Acute Myocardial InfarctionNCT01401036
Nobori And Uncoated Stent In Coronary Attack
A study testing Biolimus A9 eluting stents and uncoated stent in people with Acute Myocardial Infarction, run by Shigeru Saito at 50 sites in Japan.
Trial summary
Drug-eluting stents reduce rates of restenosis and reintervention, as compared with uncoated stents. Data are limited regarding the safety and efficacy of Nobori (Biolimus A9 Eluting Stent) in primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Biolimus A9 eluting stents and uncoated stent
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,537 participants
- Where
- 50 sitesJapan
- Study dates
- Jul 2011to 7 Dec 2017
- Phase
- Interventional
- 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
Who may be able to join
- age more than 20 years old
- chest pain lasting more than 20 min
- symptoms beginning within 12 hours before characterization
- electrocardiogram showing ST-segment elevation or new appearance of left bundle branch block
- increase in cardiac enzymes to more than 5-fold the normal laboratory values
- infarct-related vessel are anatomically suitable for percutaneous revascularization
- patients gave their signed, informed consent
Who cannot join
- previous stent implantation within 30 days
- allergy to any of the followings : aspirin, heparin, clopidogrel, biolimus A9 or its derivatives, stainless steel 316L, PLA (Poly-Lactic Acid) Polymer or its derivatives, and contrast media
- elective surgery scheduled within 6 months
- renal insufficiency with creatinine level of more than 2.5 mg/dL
- patients associated with bleeding and/or clotting disorders, and those refusing blood transfusion
- history of massive gastrointestinal or urinary tract bleeding within 6 months
- patients currently enrolled in other clinical trials
- pregnancy
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
Japan50 sites
Tokyo nishi tokusyukai hospital
Akishima
Shonan Atsugi Hospital
Atsugi, Kanagawa, 243-0033
Shonan Atsugi hospital
Atsugi
Tokai University Hachioji Hospital
Hachiōji
Hakodate Municipal Hospital
Hakodate
Hiratsuka kyosai hospital
Hiratsuka
Tokai University Hospital
Isehara
Ishikawa Prefectural Central Hospital
Ishikawa
Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533
Kanazawa Cardiovascular Hospital
Kanazawa
Kasukabe chuo general Hospital
Kasukabe
St.Marianna University School of Medicine Hospital
Kawasaki
Chikamori Hospital
Kochi
Komaki Municipal Hospital
Komaki
Saitama Tobu Junkanki Hospital
Koshigoe
Kurashiki Sentral Hospital
Kurashiki
Kyoto Katsura Hospital
Kyoto
Hayama Heart Center
Miura
Omuta Tenryo Hospital
Omuta
Osaki citizen hospital
Ōsaki
Saga Medical University Hospital
Saga
Saga-ken Medical Center Koseikan
Saga
Toshiba Rinkan Hospital
Sagamihara
Hokkaido Syakaihoken Hospital
Sapporo
Sapporo Hogashi Tokusyukai Hospital
Sapporo
Sapporo Tokusyukai Hospital
Sapporo
Sasebo Chuo hospital
Sasebo
Tosei General Hospital
Seto
Jichi Medical University Hospital
Shimotsuke
Sakurakai Takahashi Hospital
Suma
Taoka Hospital
Tokushima
Tokushima medical university hospital
Tokushima
Imus Katsushika Heart Center
Tokyo
Showa University Fujigaoka Hospital
Tokyo
Showa University Hospital
Tokyo
The Cardiovascular Institute
Tokyo
Toho University Hospital
Tokyo
Toho university ohashi medical center
Tokyo
Tokyo Medical and Dental Universtity Hospital
Tokyo
Tokyo medical University hospital
Tokyo
Toyama Prefectural Central Hospital
Toyama
Izumikawa Hospital
Unzen
Urazoe general hospital
Urazoe
Shonai Amarume Hospital
Yamagata, 9997782
Saiseikai Yamaguchi General Hospital
Yamaguchi
Yamato Seiwa Hospital
Yamato
Yao General Hospital
Yao
Kanagawa Cardiovascular and Respiratory Center
Yokohama
Saiseikai Yokohama Tobu Hospital
Yokohama
Yokohama Medical University Hospital
Yokohama
About this study
Official title: Clinical Trial of Nobori Versus Uncoated Stents In Acute Myocardial Infarction
Drug-eluting stents reduce rates of restenosis and reintervention, as compared with uncoated stents. Data are limited regarding the safety and efficacy of Nobori (Biolimus A9 Eluting Stent) in primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). Accordingly, the investigators will compare the outcomes of primary PCI for AMI between patients receiving Nobori versus uncoated stents.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Biolimus A9 eluting stents, uncoated stent
- Keywords
- acute myocardial infarction, stents, angioplasty, thrombosis
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biolimus A9 eluting stentsDevice
Also called Nobori® Drug Eluting Stent made by Terumo Corporation
implantation of Biolimus A9 eluting stents
uncoated stentProcedure or surgery
implantation of any uncoated bare metal stents currently available in Japan
| Study group | Role | What they receive |
|---|---|---|
| Nobori | Active comparator | subjects receiving Biolimus A9 eluting stent implantation Receives: Device: Biolimus A9 eluting stents |
| Uncoated stents | Sham comparator | subjects receiving uncoated stent implantation Receives: Procedure: uncoated stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiac and cerebrovascular events (MACE)
MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization
Measured: 1 year
Secondary outcomes (3)
major adverse cardiac and cerebrovascular events (MACE)
MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization
Measured: 1 week
stent thrombosis
Measured: 1 week and 1 year
target lesion revascularization
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startJul 2011
- Primary completion5 Aug 2015
- Study completion7 Dec 2017
Why it stopped: Insufficient data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,537 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shigeru Saito
- Sponsor type
- Research network
- Collaborators
- NPO International TRI Network
- Responsible party
- Sponsor-investigator, Shigeru Saito, NAUSICA Investigators
- Investigators
- Shigeru Saito, MD, Principal investigator, NPO International TRI Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401036
- Sponsor's protocol ID
- 20110629
- Status last verified
- Aug 2018
- First submitted
- 20 Jul 2011
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Nobori Versus Uncoated Stents In Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01401036
- Acronym / sponsor ID
- 20110629
- Conditions
- Acute Myocardial Infarction
- Keywords
- acute myocardial infarction, stents, angioplasty, thrombosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient data collection
- Enrolment
- 1,537 participants (actual)
- Lead sponsor
- Shigeru SaitoResearch network
- Collaborators
- NPO International TRI Network
- Study start
- Jul 2011 (actual)
- Primary completion
- 5 Aug 2015 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 25 Jul 2011 (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.
Drug-eluting stents reduce rates of restenosis and reintervention, as compared with uncoated stents. Data are limited regarding the safety and efficacy of Nobori (Biolimus A9 Eluting Stent) in primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). Accordingly, the investigators will compare the outcomes of primary PCI for AMI between patients receiving Nobori versus uncoated stents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nobori | Active comparator | Device: Biolimus A9 eluting stentssubjects receiving Biolimus A9 eluting stent implantation |
| Uncoated stents | Sham comparator | Procedure: uncoated stentsubjects receiving uncoated stent implantation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age more than 20 years old
- chest pain lasting more than 20 min
- symptoms beginning within 12 hours before characterization
- electrocardiogram showing ST-segment elevation or new appearance of left bundle branch block
- increase in cardiac enzymes to more than 5-fold the normal laboratory values
Key exclusion criteria (8 listed)
- previous stent implantation within 30 days
- allergy to any of the followings : aspirin, heparin, clopidogrel, biolimus A9 or its derivatives, stainless steel 316L, PLA (Poly-Lactic Acid) Polymer or its derivatives, and contrast media
- elective surgery scheduled within 6 months
- renal insufficiency with creatinine level of more than 2.5 mg/dL
- patients associated with bleeding and/or clotting disorders, and those refusing blood transfusion
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 |
|---|---|---|
| Biolimus A9 eluting stentsAlso: Nobori® Drug Eluting Stent made by Terumo Corporationimplantation of Biolimus A9 eluting stents | Device | Nobori |
| uncoated stentimplantation of any uncoated bare metal stents currently available in Japan | Procedure or surgery | Uncoated stents |
Primary outcome
major adverse cardiac and cerebrovascular events (MACE)
Time frame: 1 year
MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization
3 secondary outcomes
major adverse cardiac and cerebrovascular events (MACE)
Time frame: 1 week
stent thrombosis
Time frame: 1 week and 1 year
target lesion revascularization
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Insufficient data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
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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.
Shigeru Saito, MD principal investigator
NPO International TRI Network
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biolimus A9 eluting stents and uncoated stent in people with Acute Myocardial Infarction, run by Shigeru Saito at 50 sites 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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Insufficient data collection). Results are not available in the source record.
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?
major adverse cardiac and cerebrovascular events (MACE) (time frame: 1 year). 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 27 Aug 2018.