Coronary DiseasePhase 3NCT02348021
Leaders Free Japan
A Phase 3 study testing Percutaneous coronary intervention (PCI) and Dual Anti Platelet Therapy in people with Coronary Disease, run by Biosensors Europe SA at 1 site in Japan.
Trial summary
Prospective, multi-center, non-randomized, open-label trial designed to enroll 139 patients in Japan. All patients will receive a DCS and will be followed for 2 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Percutaneous coronary intervention (PCI) and Dual Anti Platelet Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2014to Jul 2017
- Phase
- Phase 3
- 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
- Any indication for PCI-S in patients deemed at high risk for bleeding and candidates for 1 month DAPT. This includes candidates with stable angina, silent ischemia, ACS (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.
- Reasons of unsuitability for > 1 month dual antiplatelet treatment must include one or MORE of the following:
- Adjunctive oral anticoagulation treatment planned to continue after PCI
- Age ≥ 75 years old
- Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to enrollment)
- Any prior intracerebral bleed
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- Any stroke in the last 12 months
- Hospital admission for bleeding during the prior 12 months
- Non skin cancer diagnosed or treated < 3 years
- Planned daily NSAID (other than aspirin) or steroids for >30 days after PCI
- Planned surgery that would require interruption of DAPT (within next 12 months)
- Renal failure defined as: Creatinine clearance <40 ml/min
- Thrombocytopenia (PLT <100,000/mm3)
- Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
- Expected non-compliance to prolonged DAPT for other medical reasons
Who cannot join
- Pregnant and breastfeeding women
- Patients expected not to comply with 30 days DAPT
- Patients requiring a planned staged PCI procedure more than one week after the index procedure
- Procedure planned to require non-study stents, or stand-alone POBA or stand-alone atherectomy
- Active bleeding at the time of inclusion
- Reference vessel diameter <2.25 ~ >4.0mm
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- Cardiogenic shock
- Compliance with long-term single anti-platelet therapy unlikely
- A known hypersensitivity or contraindication to aspirin, clopidogrel or other P2Y12 inhibitor (if applicable), stainless steel, zinc, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated
- PCI during the previous 12 months for a lesion other than the target lesion of the index procedure
- Participation in another clinical trial (12 months after index procedure)
- Patients with a life expectancy of < 1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BF-14J01 Drug Coated Stent (DCS) Clinical Trial
Prospective, multi-center, non-randomized, open-label trial designed to enroll 139 patients in Japan. All patients will receive a DCS and will be followed for 2 years.
Read the detailed description
In this study all patients will receive the a Drug Coated Stent and will receive one month Dual Anti Platelet Therapy.
- Conditions
- Coronary Disease
- Being tested
- Percutaneous coronary intervention (PCI), Dual Anti Platelet Therapy
- Medical subject headings
- Coronary Disease
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
Dual Anti Platelet TherapyDrug
All patients will receive Dual Anti Platelet Therapy for one month
| Study group | Role | What they receive |
|---|---|---|
| Drug Coated Stent | Other | All patients in the one arm will be treated by PCI with the Drug Coated Stent. Receives: Procedure: Percutaneous coronary intervention (PCI); Drug: Dual Anti Platelet Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients that experienced either a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis.
Measured: 1 year
The number of patients that experienced a clinically driven target lesion revascularization
Measured: 1 year
Secondary outcomes (6)
The number of patients that experienced a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis
Measured: 2 years
The number of patients that experienced a clinically driven target lesion revascularization
Measured: 2 years
The number of patients that experienced a Bleeding per BARC criteria
Measured: 30, 60 and 120 days, and 12 and 24 months
The number of patients that experienced a cardiac death
Measured: 30, 60 and 120 days, and 12 and 24 months
The number of patients that experienced a definite/probable stent thrombosis.
Measured: 30, 60 and 120 days, and 12 and 24 months
The number of patients that experienced a myocardial infarction
Measured: 30, 60 and 120 days, and 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJul 2014
- Primary completionApr 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosensors Europe SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biosensors Japan Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- Shigeru Saito, MD, Principal investigator, Shonan Kamakura General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348021
- Sponsor's protocol ID
- 14J01
- Status last verified
- Sep 2015
- First submitted
- 11 Sep 2014
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BF-14J01 Drug Coated Stent (DCS) Clinical Trial
- ClinicalTrials.gov ID
- NCT02348021
- Acronym / sponsor ID
- 14J01
- Conditions
- Coronary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Biosensors Europe SAIndustry (pharma, biotech, devices)
- Collaborators
- Biosensors Japan Co. Ltd.
- Study start
- Jul 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 28 Jan 2015 (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.
Prospective, multi-center, non-randomized, open-label trial designed to enroll 139 patients in Japan. All patients will receive a DCS and will be followed for 2 years.
Detailed description
In this study all patients will receive the a Drug Coated Stent and will receive one month Dual Anti Platelet Therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug Coated Stent | Other | Procedure: Percutaneous coronary intervention (PCI), Drug: Dual Anti Platelet TherapyAll patients in the one arm will be treated by PCI with the Drug Coated Stent. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Any indication for PCI-S in patients deemed at high risk for bleeding and candidates for 1 month DAPT. This includes candidates with stable angina, silent ischemia, ACS (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.
- Reasons of unsuitability for > 1 month dual antiplatelet treatment must include one or MORE of the following:
- Adjunctive oral anticoagulation treatment planned to continue after PCI
- Age ≥ 75 years old
- Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to enrollment)
Key exclusion criteria (12 listed)
- Pregnant and breastfeeding women
- Patients expected not to comply with 30 days DAPT
- Patients requiring a planned staged PCI procedure more than one week after the index procedure
- Procedure planned to require non-study stents, or stand-alone POBA or stand-alone atherectomy
- Active bleeding at the time of inclusion
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 |
|---|---|---|
| Percutaneous coronary intervention (PCI) | Procedure or surgery | Drug Coated Stent |
| Dual Anti Platelet TherapyAll patients will receive Dual Anti Platelet Therapy for one month | Drug | Drug Coated Stent |
Primary outcome
The number of patients that experienced either a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis.
Time frame: 1 year
The number of patients that experienced a clinically driven target lesion revascularization
Time frame: 1 year
6 secondary outcomes
The number of patients that experienced a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis
Time frame: 2 years
The number of patients that experienced a clinically driven target lesion revascularization
Time frame: 2 years
The number of patients that experienced a Bleeding per BARC criteria
Time frame: 30, 60 and 120 days, and 12 and 24 months
The number of patients that experienced a cardiac death
Time frame: 30, 60 and 120 days, and 12 and 24 months
The number of patients that experienced a definite/probable stent thrombosis.
Time frame: 30, 60 and 120 days, and 12 and 24 months
The number of patients that experienced a myocardial infarction
Time frame: 30, 60 and 120 days, and 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
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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
Shonan Kamakura General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Percutaneous coronary intervention (PCI) and Dual Anti Platelet Therapy in people with Coronary Disease, run by Biosensors Europe SA 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 15 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: status not confirmed, as of the sponsor's last update on 29 Sep 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
The number of patients that experienced either a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis. (time frame: 1 year). The study lists 2 primary outcomes in all. 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 29 Sep 2015.