Coronary Artery DiseaseNCT02513810
A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-eluting Stent Implantation
A study testing BioFreedom with 1 month DAPT and BioMatrix or Ultimaster with 6 to 12 months DAPT in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
DES are preferred over BMS for most patients, however prolonged dual antiplatelet therapy is required for patients treated with DES for prevention of late or very late stent thrombosis. which increases a risk of major bleeding. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- BioFreedom with 1 month DAPT and BioMatrix or Ultimaster with 6 to 12 months DAPT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,020 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Dec 2015to Sep 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 19 years old
- Patients with ischemic heart disease who are considered for coronary revascularization with PCI
- Significant coronary de novo lesion
Who cannot join
- Acute myocardial infarction
- Complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesion
- Need to use of dual antiplatelet therapy more than 1 month because of other medical conditions
- Cardiogenic shock or experience of cardiopulmonary resuscitation
- Contraindication or hypersensitivity to Biolimus A9, stainless steel, heparin, antiplatelet agents or contrast media
- History of documented prior cerebrovascular attack within 6 months
Show all 11Show fewer
- Treated with any stent within 3 months
- Reference vessel diameter <2.25 mm or >4.0 mm
- Pregnant women or women with potential childbearing
- Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
- Inability to understand or read the informed content
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752
About this study
DES are preferred over BMS for most patients, however prolonged dual antiplatelet therapy is required for patients treated with DES for prevention of late or very late stent thrombosis. which increases a risk of major bleeding. BioFreedom is a Biolimus A9-coated stent that consists of a stainless steel stent platform with a textured abluminal surface without use of any polymer in the coating. Biolimus A9 rapid release and polymer-free property may give BioFreedom the advantages of both DES and BMS that may require less duration of DAPT. BioMatrix Flex, Biolimus-eluting stent with biodegradable polymer, also demonstrated safety and efficacy. We will compare these two difference types of Biolimus A9-eluting stents with different duration of DAPT. With proven adequate and safe duration, we will compare between one versus more than six months of dual antiplatelet therapy after Biolimus A9-eluting stents implantation using different properties of BioFreedom and BioMatrix Flex.
- Conditions
- Coronary Artery Disease
- Being tested
- BioFreedom with 1 month DAPT, BioMatrix or Ultimaster with 6 to 12 months DAPT
- 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.
BioFreedom with 1 month DAPTDevice
The cath lab will follow site standard operating procedures for PTCA and stenting. Information will be collected and recorded on the treated study vessel including angiographic parameters. Dual antiplatelet therapy after PCI will be continued for 1 month.
BioMatrix or Ultimaster with 6 to 12 months DAPTDevice
The cath lab will follow site standard operating procedures for PTCA and stenting. Information will be collected and recorded on the treated study vessel including angiographic parameters. Dual antiplatelet therapy after PCI will be the duration of dual antiplatelet therapy will be 6 to 12 months at the discretion of the interventionist.
| Study group | Role | What they receive |
|---|---|---|
| Short-term DAPT after Biofreedom | Experimental | Not described Receives: Device: BioFreedom with 1 month DAPT |
| Long-term DAPT after BioMatrix or Ultimaster | Active comparator | Not described Receives: Device: BioMatrix or Ultimaster with 6 to 12 months DAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of major adverse cardiovascular events
events including cardiac death, nonfatal myocardial infarction, target vessel revascularization, major bleeding and cerebrovascular accident
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 posted3 Aug 2015 (estimated)
- Study start2 Dec 2015
- Primary completion17 Sep 2019
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- 3,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513810
- Sponsor's protocol ID
- 1-2015-0040
- Status last verified
- Mar 2020
- First submitted
- 31 Jul 2015
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Jin IT, Kim Y, Heo SJ, Lee YJ, Lee SJ, Hong SJ, Ahn CM, Kim JS, Cho DK, Ko YG, Choi D, Hong MK, Kim BK. Comparison of Short-term and Standard Duration Dual Antiplatelet Therapy in Elderly Patients: A Pooled Analysis of Five Korean Randomized Clinical Trials. Korean Circ J. 2025 Dec;55(12):1125-1137. doi: 10.4070/kcj.2025.0093. Epub 2025 Jul 14.
PubMed 41044734Lee YJ, Cho JY, Yun KH, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Kim JS. Impact of one-month DAPT followed by aspirin monotherapy in patients undergoing percutaneous coronary intervention according to clinical presentation: a post hoc analysis of the randomised One-Month DAPT trial. EuroIntervention. 2022 Aug 19;18(6):471-481. doi: 10.4244/EIJ-D-22-00135.
PubMed 35470799Hong SJ, Kim JS, Hong SJ, Lim DS, Lee SY, Yun KH, Park JK, Kang WC, Kim YH, Yoon HJ, Won H, Nam CM, Ahn CM, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; One-Month DAPT Investigators. 1-Month Dual-Antiplatelet Therapy Followed by Aspirin Monotherapy After Polymer-Free Drug-Coated Stent Implantation: One-Month DAPT Trial. JACC Cardiovasc Interv. 2021 Aug 23;14(16):1801-1811. doi: 10.1016/j.jcin.2021.06.003. Epub 2021 Jul 28.
PubMed 34332946
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-eluting Stent Implantation
- ClinicalTrials.gov ID
- NCT02513810
- Acronym / sponsor ID
- 1-2015-0040
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,020 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- Sep 2020 (estimated)
- First posted
- 3 Aug 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.
DES are preferred over BMS for most patients, however prolonged dual antiplatelet therapy is required for patients treated with DES for prevention of late or very late stent thrombosis. which increases a risk of major bleeding. BioFreedom is a Biolimus A9-coated stent that consists of a stainless steel stent platform with a textured abluminal surface without use of any polymer in the coating. Biolimus A9 rapid release and polymer-free property may give BioFreedom the advantages of both DES and BMS that may require less duration of DAPT. BioMatrix Flex, Biolimus-eluting stent with biodegradable polymer, also demonstrated safety and efficacy. We will compare these two difference types of Biolimus A9-eluting stents with different duration of DAPT. With proven adequate and safe duration, we will compare between one versus more than six months of dual antiplatelet therapy after Biolimus A9-eluting stents implantation using different properties of BioFreedom and BioMatrix Flex.
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 after Biofreedom | Experimental | Device: BioFreedom with 1 month DAPT |
| Long-term DAPT after BioMatrix or Ultimaster | Active comparator | Device: BioMatrix or Ultimaster with 6 to 12 months DAPT |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥ 19 years old
- Patients with ischemic heart disease who are considered for coronary revascularization with PCI
- Significant coronary de novo lesion
Key exclusion criteria (11 listed)
- Acute myocardial infarction
- Complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesion
- Need to use of dual antiplatelet therapy more than 1 month because of other medical conditions
- Cardiogenic shock or experience of cardiopulmonary resuscitation
- Contraindication or hypersensitivity to Biolimus A9, stainless steel, heparin, antiplatelet agents or contrast media
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 |
|---|---|---|
| BioFreedom with 1 month DAPTThe cath lab will follow site standard operating procedures for PTCA and stenting. Information will be collected and recorded on the treated study vessel including angiographic parameters. Dual antiplatelet therapy after PCI will be continued for 1 month. | Device | Short-term DAPT after Biofreedom |
| BioMatrix or Ultimaster with 6 to 12 months DAPTThe cath lab will follow site standard operating procedures for PTCA and stenting. Information will be collected and recorded on the treated study vessel including angiographic parameters. Dual antiplatelet therapy after PCI will be the duration of dual antiplatelet therapy will be 6 to 12 months at the discretion of the interventionist. | Device | Long-term DAPT after BioMatrix or Ultimaster |
Primary outcome
Composite of major adverse cardiovascular events
Time frame: 1 year
events including cardiac death, nonfatal myocardial infarction, target vessel revascularization, major bleeding and cerebrovascular accident
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 41044734Jin IT, Kim Y, Heo SJ, Lee YJ, Lee SJ, Hong SJ, Ahn CM, Kim JS, Cho DK, Ko YG, Choi D, Hong MK, Kim BK. Comparison of Short-term and Standard Duration Dual Antiplatelet Therapy in Elderly Patients: A Pooled Analysis of Five Korean Randomized Clinical Trials. Korean Circ J. 2025 Dec;55(12):1125-1137. doi: 10.4070/kcj.2025.0093. Epub 2025 Jul 14.
- Derived from this study: PubMed 35470799Lee YJ, Cho JY, Yun KH, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Kim JS. Impact of one-month DAPT followed by aspirin monotherapy in patients undergoing percutaneous coronary intervention according to clinical presentation: a post hoc analysis of the randomised One-Month DAPT trial. EuroIntervention. 2022 Aug 19;18(6):471-481. doi: 10.4244/EIJ-D-22-00135.
- Derived from this study: PubMed 34332946Hong SJ, Kim JS, Hong SJ, Lim DS, Lee SY, Yun KH, Park JK, Kang WC, Kim YH, Yoon HJ, Won H, Nam CM, Ahn CM, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; One-Month DAPT Investigators. 1-Month Dual-Antiplatelet Therapy Followed by Aspirin Monotherapy After Polymer-Free Drug-Coated Stent Implantation: One-Month DAPT Trial. JACC Cardiovasc Interv. 2021 Aug 23;14(16):1801-1811. doi: 10.1016/j.jcin.2021.06.003. Epub 2021 Jul 28.
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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 study testing BioFreedom with 1 month DAPT and BioMatrix or Ultimaster with 6 to 12 months DAPT in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
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 11 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 4 Mar 2020. 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 South Korea. 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?
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?
Composite of major adverse cardiovascular events (time frame: 1 year). 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 NCT02513810, which also lists 3 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 4 Mar 2020.