Coronary Artery DiseasePhase 4NCT03947229
A Randomized Comparison of CLOpidogrel Monotherapy Versus Extended Dual-antiplatelet Therapy Beyond 12 Months After Implantation of Drug-eluting StEnts in High-risk Lesions or Patients; A-CLOSE Trial
A Phase 4 study testing Clopidogrel mono-therapy and Dual-antiplatelet therapy in people with Coronary Artery Disease and DES, run by Yonsei University at 1 site in South Korea.
Trial summary
We hypothesized that clopidogrel mono-therapy will not be inferior to the extended DAPT in terms of the occurrence of both ischemic and bleeding events, for lesions or patients at high risk for either ischemic or bleeding complications 12 months after drug-eluting stent (DES) implantation. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Coronary Artery Disease, DES
- What is being tested?
- Clopidogrel mono-therapy and Dual-antiplatelet therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Aug 2019to 16 Aug 2026
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >19 years old
- Patients who underwent DES implantation 12 months (-1 to +5 months) previously.
- High risk characteristics (clinical or lesion) for ischemic events (must at least one)
- High risk patients; clinical criteria
- Acute coronary syndrome
- Previous history of cerebrovascular accidents
Show all 20Show fewer
- History of peripheral artery intervention
- Heart failure (left ventricular ejection fraction ≤40%)
- Diabetes treated with medication
- Chronic renal insufficiency including end-stage renal diseases
- High risk lesions; angiographic or procedural criteria
- Left main diseases
- Bifurcation lesions
- Chronic total occlusion
- In-stent restenotic lesions
- Graft lesions
- Diffuse long lesions requiring total stent length ≥28 mm
- Calcified lesions requiring atherectomy
- Multivessel coronary artery disease with multiple stents
- Small vessel disease requiring stent diameter of ≤2.5 mm
Who cannot join
- Age> 80 years
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
- Refusal or inability to understand of informed consent
- Need for chronic oral anticoagulation
- History of major bleeding within 3 months prior to randomization
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Severance Cardiovascular Hospital Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, South Korea
Seoul
About this study
We hypothesized that clopidogrel mono-therapy will not be inferior to the extended DAPT in terms of the occurrence of both ischemic and bleeding events, for lesions or patients at high risk for either ischemic or bleeding complications 12 months after drug-eluting stent (DES) implantation.
Read the detailed description
Patients at high risk for either ischemic or bleeding complications, but who were stable without clinical evetns for 12 months after DES implantation will be included in this study. Eligible patients will be randomized to continue DAPT (aspirin plus clopidogrel) for further 24 months or to change to single antiplatelet therapy with clopidogrel (clopidogrel-alone). Randomization will be stratified according to 1) clinical presentation (acute coronary syndrome or stable coronary artery disease) and 2) age (≥75 or <75). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative. All of study subjects will be have an outpatient visit as scheduled in outpatient clinic. Occurrence of study endpoints will be documented at clinical visit or telephone interview every 6 months up to 24 months after randomization. Antiplatelet drugs will be open-label and prescribed by attending physician.
- Conditions
- Coronary Artery Disease, DES
- Being tested
- Clopidogrel mono-therapy, Dual-antiplatelet therapy
- Keywords
- Patients who underwent percutaneous coronary intervention with DES implantation carrying high risks for the recurrent major adverse events., anti platelet therapy, bleeding
- Medical subject headings
- Coronary Artery Disease, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel mono-therapyDrug
Patients will receive clopidogrel (75 mg once daily) monotherapy without co-administration of aspirin for 24 months after randomization.
Dual-antiplatelet therapyDrug
Patients will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 24 months after randomization.
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel mono-therapy | Active comparator | After randomization, patients will receive clopidogrel monotherapy after DES implantation for 24 months. Receives: Drug: Clopidogrel mono-therapy |
| Dual-antiplatelet therapy | Active comparator | Patients will receive dual antiplatelet consisting of aspirin and clopidogrel. Receives: Drug: Dual-antiplatelet therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Adverse Clinical Events (NACE)
The composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or bleeding (BARC type 2, 3, or 5)
Measured: 24 months
Secondary outcomes (5)
Each component of net adverse clinical events
Measured: 24 months
All-cause or cardiovascular mortality
Measured: 24 months
Major or minor bleeding
Major or minor bleeding would be defined by BARC and TIMI criteria
Measured: 24 months
Major adverse cardiac event
Major Adverse Cardiac events includes all-cause of death, myocardial infarction, stent thrombosis, or ischemia-driven target vessel revascularization
Measured: 24 months
Major adverse cardiac and cerebrovascular event
Major adverse cardiac and cerebrovascular event includes all-cause death, myocardial infarction, stent thrombosis, stroke, or ischemia-driven target vessel revascularization
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start14 Aug 2019
- Primary completion16 Aug 2025 (estimated)
- Study completion16 Aug 2026 (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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be assigned to continue DAPT (aspirin plus clopidogrel) or to change to single antiplatelet therapy with clopidogrel (clopidogrel-alone) for further 24 months.
- Masking
- None (open label)
- Enrolment
- 3,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947229
- Sponsor's protocol ID
- 4-2019-0234
- Status last verified
- Oct 2024
- First submitted
- 8 May 2019
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee SJ, Lee YJ, Lee K, Cho DK, Cho YH, Ahn SG, Yun KH, Jang JY, Kim S, Kim YH, Park YH, Kwon SU, Hur SH, Kang TS, Shin ES, Lee JB, Jeon KH, Kim U, Kim WH, Hong BK, Lee SH, Hong SJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Kim BK; A-CLOSE investigators. Clopidogrel or Dual Antiplatelet Therapy in High-Ischemic-Risk Patients. N Engl J Med. 2026 Aug 29. doi: 10.1056/NEJMoa2608533. Online ahead of print.
PubMed 42670964
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of CLOpidogrel Monotherapy Versus Extended Dual-antiplatelet Therapy Beyond 12 Months After Implantation of Drug-eluting StEnts in High-risk Lesions or Patients; A-CLOSE Trial
- ClinicalTrials.gov ID
- NCT03947229
- Acronym / sponsor ID
- 4-2019-0234
- Conditions
- Coronary Artery Disease, DES
- Keywords
- Patients who underwent percutaneous coronary intervention with DES implantation carrying high risks for the recurrent major adverse events., anti platelet therapy, bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,200 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 16 Aug 2025 (estimated)
- Study completion
- 16 Aug 2026 (estimated)
- First posted
- 13 May 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.
We hypothesized that clopidogrel mono-therapy will not be inferior to the extended DAPT in terms of the occurrence of both ischemic and bleeding events, for lesions or patients at high risk for either ischemic or bleeding complications 12 months after drug-eluting stent (DES) implantation.
Detailed description
Patients at high risk for either ischemic or bleeding complications, but who were stable without clinical evetns for 12 months after DES implantation will be included in this study. Eligible patients will be randomized to continue DAPT (aspirin plus clopidogrel) for further 24 months or to change to single antiplatelet therapy with clopidogrel (clopidogrel-alone). Randomization will be stratified according to 1) clinical presentation (acute coronary syndrome or stable coronary artery disease) and 2) age (≥75 or <75). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative. All of study subjects will be have an outpatient visit as scheduled in outpatient clinic. Occurrence of study endpoints will be documented at clinical visit or telephone interview every 6 months up to 24 months after randomization. Antiplatelet drugs will be open-label and prescribed by attending physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be assigned to continue DAPT (aspirin plus clopidogrel) or to change to single antiplatelet therapy with clopidogrel (clopidogrel-alone) for further 24 months.
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel mono-therapy | Active comparator | Drug: Clopidogrel mono-therapyAfter randomization, patients will receive clopidogrel monotherapy after DES implantation for 24 months. |
| Dual-antiplatelet therapy | Active comparator | Drug: Dual-antiplatelet therapyPatients will receive dual antiplatelet consisting of aspirin and clopidogrel. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients >19 years old
- Patients who underwent DES implantation 12 months (-1 to +5 months) previously.
- High risk characteristics (clinical or lesion) for ischemic events (must at least one)
- High risk patients; clinical criteria
- Acute coronary syndrome
Key exclusion criteria (6 listed)
- Age> 80 years
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
- Refusal or inability to understand of informed consent
- Need for chronic oral anticoagulation
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 |
|---|---|---|
| Clopidogrel mono-therapyPatients will receive clopidogrel (75 mg once daily) monotherapy without co-administration of aspirin for 24 months after randomization. | Drug | Clopidogrel mono-therapy |
| Dual-antiplatelet therapyPatients will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 24 months after randomization. | Drug | Dual-antiplatelet therapy |
Primary outcome
Net Adverse Clinical Events (NACE)
Time frame: 24 months
The composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or bleeding (BARC type 2, 3, or 5)
5 secondary outcomes
Each component of net adverse clinical events
Time frame: 24 months
All-cause or cardiovascular mortality
Time frame: 24 months
Major or minor bleeding
Time frame: 24 months
Major adverse cardiac event
Time frame: 24 months
Major adverse cardiac and cerebrovascular event
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Derived from this study: PubMed 42670964Lee SJ, Lee YJ, Lee K, Cho DK, Cho YH, Ahn SG, Yun KH, Jang JY, Kim S, Kim YH, Park YH, Kwon SU, Hur SH, Kang TS, Shin ES, Lee JB, Jeon KH, Kim U, Kim WH, Hong BK, Lee SH, Hong SJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Kim BK; A-CLOSE investigators. Clopidogrel or Dual Antiplatelet Therapy in High-Ischemic-Risk Patients. N Engl J Med. 2026 Aug 29. doi: 10.1056/NEJMoa2608533. Online ahead of print.
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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 Phase 4 study testing Clopidogrel mono-therapy and Dual-antiplatelet therapy in people with Coronary Artery Disease and DES, 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 20 inclusion and 6 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 24 Oct 2024. 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?
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?
Net Adverse Clinical Events (NACE) (time frame: 24 months). 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 NCT03947229, 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 24 Oct 2024.