Coronary Artery DiseaseNCT03873012
Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents Versus Biolimus A9-eluting Stents
An observational study of Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
This study is a retrospective and prospective follow-up study of patients who were participating in a randomized comparative study (DETECT-OCT trial) to determine the duration of dual antiplatelet therapy for neointimal hyperplasia after Biolimus stent and Everolimus stent insertion . Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 894 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2019to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Participants who already enrolled in DETECT-OCT
Who may be able to join
- 1. patients who were enrolled in the previous DETECT-OCT study
- 2. Patients who agreed with informed consents
Who cannot join
- 1. Patients who disagreed with informed consents
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752
About this study
Official title: Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents Versus Biolimus A9-eluting Stents: Retrospective and Prospective Follow-up Study for Patients Who Were Enrolled in the Previous DETECT-OCT Study
This study is a retrospective and prospective follow-up study of patients who were participating in a randomized comparative study (DETECT-OCT trial) to determine the duration of dual antiplatelet therapy for neointimal hyperplasia after Biolimus stent and Everolimus stent insertion . The primary objective of this study was to determine the duration of double antiplatelet therapy (DAPT) based on OCT results at 3 months after percutaneous coronary intervention with OCT guide and percutaneous coronary intervention with guided angiography. After that, patients who were enrolled in the previous DETECT-OCT study will be followed up for a 10 years follow-up.
Read the detailed description
This clinical trial will be followed for a long time until the 5th and 10th years of patients who have been registered for the DETECT-OCT study To assess the patient's status at 5- and 10-year, follow-up visits are scheduled at the outpatient visit if they are currently followed-up at the registry. However, if there is no follow-up observation at the current registrar, we will follow-up the telephone survey and visit as much as possible. Patients who have already passed the 5-year follow-up period from January 2, 2013, the first time to register, will be followed up by medical records to confirm the progress. To track the progress to the 10-year follow-up, we will conduct prospective observations by telephone survey.
- Conditions
- Coronary Artery Disease
- Keywords
- Dual antiplatelet therapy duration, Optical coherence tomography
- 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.
| Study group | Role | What they receive |
|---|---|---|
| OCT-guided group | OCT-guided PCI with EES or BES | |
| Angiography-guidance group | Angio-guided PCI with EES or BES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Free from death
Measured: At 5 years
Overall survival
Free from death
Measured: At 10 years
Cardiac death
Within 30 days after intervention, deaths due to myocardial infarction, cardiac perforation, tamponade or arrhythmia or death associated with intervention, death due to complications of intervention, and major cardiovascular deaths that can not be ruled out by a judgment of the screening adverse reaction review committee.
Measured: At 5 years
Cardiac death
Within 30 days after intervention, deaths due to myocardial infarction, cardiac perforation, tamponade or arrhythmia or death associated with intervention, death due to complications of intervention, and major cardiovascular deaths that can not be ruled out by a judgment of the screening adverse reaction review committee.
Measured: At 10 years
Myocardial infarction
(Non-Q-wave and Q-wave) due to occlusion of the target lesion or severe restenosis. The criteria for classification and diagnosis of myocardial infarction follow the Academic Research Consortium and the Third Universal Definition of MI. Coronary intervention Clinically significant myocardial infarction following the procedure has recently been defined by the Society for Cardiovascular Angiography and Interventions (SCAI)
Measured: At 5 years
Myocardial infarction
(Non-Q-wave and Q-wave) due to occlusion of the target lesion or severe restenosis. The criteria for classification and diagnosis of myocardial infarction follow the Academic Research Consortium and the Third Universal Definition of MI. Coronary intervention Clinically significant myocardial infarction following the procedure has recently been defined by the Society for Cardiovascular Angiography and Interventions (SCAI)
Measured: At 10 years
Target lesion revascularization
Repeatedly performing percutaneous intervention or target bypass repeatedly to the target lesion due to restenosis or other complications of the target lesion. The target lesion is defined as a treated segment of the vessel, ranging from 5 mm in the proximal portion of the stent to 5 mm in the distal portion of the stent.
Measured: At 5 years
Target lesion revascularization
Repeatedly performing percutaneous intervention or target bypass repeatedly to the target lesion due to restenosis or other complications of the target lesion. The target lesion is defined as a treated segment of the vessel, ranging from 5 mm in the proximal portion of the stent to 5 mm in the distal portion of the stent.
Measured: At 10 years
Target vessel revascularization
Repeatedly performing percutaneous intervention or target bypass repeatedly to the target vessel due to restenosis or other complications of the target vessel.
Measured: At 5 years
Target vessel revascularization
Repeatedly performing percutaneous intervention or target bypass repeatedly to the target vessel due to restenosis or other complications of the target vessel.
Measured: At 10 years
Stent thrombosis
Based on the Academic Research Consortium (ARC) definition.
- Definitive stent thrombosis
- Probable stent thrombosis
- Possible stent thrombosis
Measured: At 5 years
Stent thrombosis
Based on the Academic Research Consortium (ARC) definition.
- Definitive stent thrombosis
- Probable stent thrombosis
- Possible stent thrombosis
Measured: At 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study startApr 2019 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionApr 2027 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 894 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
- NCT03873012
- Sponsor's protocol ID
- 4-2018-1167
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee SY, Ahn CM, Yoon HJ, Hur SH, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. Early Follow-Up Optical Coherence Tomographic Findings of Significant Drug-Eluting Stent Malapposition. Circ Cardiovasc Interv. 2018 Dec;11(12):e007192. doi: 10.1161/CIRCINTERVENTIONS.118.007192.
PubMed 30562088
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents Versus Biolimus A9-eluting Stents: Retrospective and Prospective Follow-up Study for Patients Who Were Enrolled in the Previous DETECT-OCT Study
- ClinicalTrials.gov ID
- NCT03873012
- Acronym / sponsor ID
- 4-2018-1167
- Conditions
- Coronary Artery Disease
- Keywords
- Dual antiplatelet therapy duration, Optical coherence tomography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 894 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 13 Mar 2019 (actual)
- 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.
This study is a retrospective and prospective follow-up study of patients who were participating in a randomized comparative study (DETECT-OCT trial) to determine the duration of dual antiplatelet therapy for neointimal hyperplasia after Biolimus stent and Everolimus stent insertion . The primary objective of this study was to determine the duration of double antiplatelet therapy (DAPT) based on OCT results at 3 months after percutaneous coronary intervention with OCT guide and percutaneous coronary intervention with guided angiography. After that, patients who were enrolled in the previous DETECT-OCT study will be followed up for a 10 years follow-up.
Detailed description
This clinical trial will be followed for a long time until the 5th and 10th years of patients who have been registered for the DETECT-OCT study To assess the patient's status at 5- and 10-year, follow-up visits are scheduled at the outpatient visit if they are currently followed-up at the registry. However, if there is no follow-up observation at the current registrar, we will follow-up the telephone survey and visit as much as possible. Patients who have already passed the 5-year follow-up period from January 2, 2013, the first time to register, will be followed up by medical records to confirm the progress. To track the progress to the 10-year follow-up, we will conduct prospective observations by telephone survey.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT-guided group | – | –OCT-guided PCI with EES or BES |
| Angiography-guidance group | – | –Angio-guided PCI with EES or BES |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who already enrolled in DETECT-OCT
Key inclusion criteria (2 listed)
- 1. patients who were enrolled in the previous DETECT-OCT study
- 2. Patients who agreed with informed consents
Key exclusion criteria (1 listed)
- 1. Patients who disagreed with informed consents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: At 5 years
Free from death
Overall survival
Time frame: At 10 years
Free from death
Cardiac death
Time frame: At 5 years
Within 30 days after intervention, deaths due to myocardial infarction, cardiac perforation, tamponade or arrhythmia or death associated with intervention, death due to complications of intervention, and major cardiovascular deaths that can not be ruled out by a judgment of the screening adverse reaction review committee.
Cardiac death
Time frame: At 10 years
Within 30 days after intervention, deaths due to myocardial infarction, cardiac perforation, tamponade or arrhythmia or death associated with intervention, death due to complications of intervention, and major cardiovascular deaths that can not be ruled out by a judgment of the screening adverse reaction review committee.
Myocardial infarction
Time frame: At 5 years
(Non-Q-wave and Q-wave) due to occlusion of the target lesion or severe restenosis. The criteria for classification and diagnosis of myocardial infarction follow the Academic Research Consortium and the Third Universal Definition of MI. Coronary intervention Clinically significant myocardial infarction following the procedure has recently been defined by the Society for Cardiovascular Angiography and Interventions (SCAI)
Myocardial infarction
Time frame: At 10 years
(Non-Q-wave and Q-wave) due to occlusion of the target lesion or severe restenosis. The criteria for classification and diagnosis of myocardial infarction follow the Academic Research Consortium and the Third Universal Definition of MI. Coronary intervention Clinically significant myocardial infarction following the procedure has recently been defined by the Society for Cardiovascular Angiography and Interventions (SCAI)
Target lesion revascularization
Time frame: At 5 years
Repeatedly performing percutaneous intervention or target bypass repeatedly to the target lesion due to restenosis or other complications of the target lesion. The target lesion is defined as a treated segment of the vessel, ranging from 5 mm in the proximal portion of the stent to 5 mm in the distal portion of the stent.
Target lesion revascularization
Time frame: At 10 years
Repeatedly performing percutaneous intervention or target bypass repeatedly to the target lesion due to restenosis or other complications of the target lesion. The target lesion is defined as a treated segment of the vessel, ranging from 5 mm in the proximal portion of the stent to 5 mm in the distal portion of the stent.
Target vessel revascularization
Time frame: At 5 years
Repeatedly performing percutaneous intervention or target bypass repeatedly to the target vessel due to restenosis or other complications of the target vessel.
Target vessel revascularization
Time frame: At 10 years
Repeatedly performing percutaneous intervention or target bypass repeatedly to the target vessel due to restenosis or other complications of the target vessel.
Stent thrombosis
Time frame: At 5 years
Based on the Academic Research Consortium (ARC) definition. 1. Definitive stent thrombosis 2. Probable stent thrombosis 3. Possible stent thrombosis
Stent thrombosis
Time frame: At 10 years
Based on the Academic Research Consortium (ARC) definition. 1. Definitive stent thrombosis 2. Probable stent thrombosis 3. Possible stent thrombosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Background: PubMed 30562088Lee SY, Ahn CM, Yoon HJ, Hur SH, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. Early Follow-Up Optical Coherence Tomographic Findings of Significant Drug-Eluting Stent Malapposition. Circ Cardiovasc Interv. 2018 Dec;11(12):e007192. doi: 10.1161/CIRCINTERVENTIONS.118.007192.
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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.
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?
An observational study of 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 13 Mar 2019. 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall survival (time frame: At 5 years). The study lists 12 primary outcomes in all. 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 NCT03873012, 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 13 Mar 2019.