Stable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery DiseasePhase 4NCT02609698
ISAR-DAPT (A Comparative Evaluation of Efficacy and Safety in the 3-Months DAPT Group vs. the 6-Months DAPT Group of Patients Treated With the Coroflex ISAR Stent; A Prospective, Multicenter, Randomized, Open-Label Clinical Trial)
A Phase 4 study testing Coroflex ISAR, 3 months DAPT and 6 months DAPT in people with Stable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery Disease, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
This clinical trial studies patients treated with the Coroflex ISAR Stent for coronary artery disease in order for the objective of verifying the non-inferiority of results that among patients who were administered DAPT for 3 months compared to patients who were administered DAPT for 6 months, in terms of the efficacy… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery Disease
- What is being tested?
- Coroflex ISAR, 3 months DAPT and 6 months DAPT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 906 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Jun 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 19 or older
- Patients who have submitted a written consent to participate in the clinical trial
- De novo lesion
- Patients scheduled for elective intervention to treat ischemic cardiovascular disease
Who cannot join
- Patients with any contraindications or hypersensitivity related to antiplatelet therapy
- Patients with Acute Myocardial Infarction (ST elevation myocardial infarction, Non ST elevation myocardial infarction)
- Patients who are anticipated to receive treatment or surgery that may require desisting the administration of antiplatelet therapy for 2 weeks or longer during the period of the clinical trial
- Chronic total occlusion (CTO) lesions, in-stent restenosis (ISR)
- Patients experiencing cardiogenic shock
- Women who are breastfeeding, pregnant, or desiring pregnancy
Show all 10Show fewer
- Patients with findings of hemorrhage
- Patients with a life expectancy of less than 1 year
- Patients who have received a drug-eluting stent (DES) procedure within the past 6 months
- Any other patients judged by the investigator to be unsuitable for the trial
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ajou University Hospital
Yeongtong-gu, Suwon, 16499
Myeong-Ho Yoon, Ph.D, MD
About this study
Official title: A Comparative Evaluation of Efficacy and Safety in the 3-Months DAPT Group vs. the 6-Months DAPT Group of Patients Treated With the Coroflex ISAR Stent; A Prospective, Multicenter, Randomized, Open-Label Clinical Trial
This clinical trial studies patients treated with the Coroflex ISAR Stent for coronary artery disease in order for the objective of verifying the non-inferiority of results that among patients who were administered DAPT for 3 months compared to patients who were administered DAPT for 6 months, in terms of the efficacy and safety of DAPT.
- Being tested
- Coroflex ISAR, 3 months DAPT, 6 months DAPT
- Keywords
- Stent, Polymer-free, Antiplatelet therapy, Clopidogrel, DES, DAPT
- Medical subject headings
- Angina, Stable, Angina, Unstable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coroflex ISARDevice
This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface.
3 months DAPTDrug
Also called Aspirin + clopidogrel for 3-months schedule after the coronary stenting
6 months DAPTDrug
Also called Aspirin + clopidogrel for 6-months schedule after the coronary stenting
| Study group | Role | What they receive |
|---|---|---|
| Coroflex ISAR 3 months DAPT | Experimental | Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 3 months Receives: Device: Coroflex ISAR; Drug: 3 months DAPT |
| Coroflex ISAR 6 months DAPT | Active comparator | Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 6 months Receives: Device: Coroflex ISAR; Drug: 6 months DAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Major Adverse Cardiac Events (MACE) (cardiac death, recurrent myocardial infarction, target lesion revascularization) at 12 months from the time of the procedure
Measured: 12 months from the time of the stenting
Secondary outcomes (3)
MACE
Measured: 6 months from the time of the stenting
Any death, cardiac death, MI, TLR, TVR
Measured: 6 months from the time of the stenting
Any death, cardiac death, MI, Stroke, TLR, TVR
Measured: 12 months from the time of the stenting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (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 Stable Angina, Unstable Angina, Silent Coronary Ischemia, 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
- 906 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Korea Co., Ltd.
- Responsible party
- Principal investigator, Myeong-Ho Yoon, Ajou University School of Medicine
- Investigators
- Myeong-Ho Yoon, Ph.D, MD, Principal investigator, Cardiovascular Center, Ajou University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609698
- Sponsor's protocol ID
- AJOU-CV-0001
- Status last verified
- Nov 2015
- First submitted
- 18 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
Publications
Jin U, Seo KW, Yang HM, Lim HS, Choi BJ, Choi SY, Shin JH, Tahk SJ, Yoo SY, Rha SW, Chung WY, Kim CH, Won KB, Pyun WB, Jang JS, Lee SY, Hong YJ, Kim MH, Hong SJ, Choi YS, Kim HY, Choi RK, Kang WC, Cho EJ, Yoon MH. Efficacy and Safety of 3 Versus 6 Months of Dual-Antiplatelet Therapy in Patients Implanted With a Coroflex ISAR Stents: A Prospective, Multicenter, Randomized Clinical Trial. J Invasive Cardiol. 2022 Sep;34(9):E653-E659. doi: 10.25270/jic/21.00330. Epub 2022 Jul 22.
PubMed 35863061
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Efficacy and Safety in the 3-Months DAPT Group vs. the 6-Months DAPT Group of Patients Treated With the Coroflex ISAR Stent; A Prospective, Multicenter, Randomized, Open-Label Clinical Trial
- ClinicalTrials.gov ID
- NCT02609698
- Acronym / sponsor ID
- AJOU-CV-0001
- Keywords
- Stent, Polymer-free, Antiplatelet therapy, Clopidogrel, DES, DAPT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 906 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Collaborators
- B. Braun Korea Co., Ltd.
- Study start
- Aug 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 20 Nov 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.
This clinical trial studies patients treated with the Coroflex ISAR Stent for coronary artery disease in order for the objective of verifying the non-inferiority of results that among patients who were administered DAPT for 3 months compared to patients who were administered DAPT for 6 months, in terms of the efficacy and safety of DAPT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coroflex ISAR 3 months DAPT | Experimental | Device: Coroflex ISAR, Drug: 3 months DAPTPatients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 3 months |
| Coroflex ISAR 6 months DAPT | Active comparator | Device: Coroflex ISAR, Drug: 6 months DAPTPatients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 6 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 19 or older
- Patients who have submitted a written consent to participate in the clinical trial
- De novo lesion
- Patients scheduled for elective intervention to treat ischemic cardiovascular disease
Key exclusion criteria (10 listed)
- Patients with any contraindications or hypersensitivity related to antiplatelet therapy
- Patients with Acute Myocardial Infarction (ST elevation myocardial infarction, Non ST elevation myocardial infarction)
- Patients who are anticipated to receive treatment or surgery that may require desisting the administration of antiplatelet therapy for 2 weeks or longer during the period of the clinical trial
- Chronic total occlusion (CTO) lesions, in-stent restenosis (ISR)
- Patients experiencing cardiogenic shock
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 |
|---|---|---|
| Coroflex ISARThis stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface. | Device | Coroflex ISAR 3 months DAPT, Coroflex ISAR 6 months DAPT |
| 3 months DAPTAlso: Aspirin + clopidogrel for 3-months schedule after the coronary stenting | Drug | Coroflex ISAR 3 months DAPT |
| 6 months DAPTAlso: Aspirin + clopidogrel for 6-months schedule after the coronary stenting | Drug | Coroflex ISAR 6 months DAPT |
Primary outcome
MACE
Time frame: 12 months from the time of the stenting
Major Adverse Cardiac Events (MACE) (cardiac death, recurrent myocardial infarction, target lesion revascularization) at 12 months from the time of the procedure
3 secondary outcomes
MACE
Time frame: 6 months from the time of the stenting
Any death, cardiac death, MI, TLR, TVR
Time frame: 6 months from the time of the stenting
Any death, cardiac death, MI, Stroke, TLR, TVR
Time frame: 12 months from the time of the stenting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Derived from this study: PubMed 35863061Jin U, Seo KW, Yang HM, Lim HS, Choi BJ, Choi SY, Shin JH, Tahk SJ, Yoo SY, Rha SW, Chung WY, Kim CH, Won KB, Pyun WB, Jang JS, Lee SY, Hong YJ, Kim MH, Hong SJ, Choi YS, Kim HY, Choi RK, Kang WC, Cho EJ, Yoon MH. Efficacy and Safety of 3 Versus 6 Months of Dual-Antiplatelet Therapy in Patients Implanted With a Coroflex ISAR Stents: A Prospective, Multicenter, Randomized Clinical Trial. J Invasive Cardiol. 2022 Sep;34(9):E653-E659. doi: 10.25270/jic/21.00330. Epub 2022 Jul 22.
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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.
Myeong-Ho Yoon, Ph.D, MD principal investigator
Cardiovascular Center, Ajou University Hospital
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 Coroflex ISAR, 3 months DAPT and 6 months DAPT in people with Stable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery Disease, run by Ajou University School of Medicine 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 4 inclusion and 10 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 20 Nov 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 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myeong-Ho Yoon, Ph.D, MD (+82-31-219-4329, yoonmh65@hanmail.net,), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 12 months from the time of the stenting). 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 NCT02609698, 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 20 Nov 2015; AzTrials last refreshed its copy on 6 Nov 2026.