Atrial FibrillationPhase 4NCT04250116
Appropriate Duration of Anti-Platelet and Thrombotic Strategy After 12 Months in Patients With Atrial Fibrillation Treated With Drug Eluting Stents
A Phase 4 study testing NOAC monotherapy and Dual antithrombotic therapy with NOAC and clopidogrel in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
Atrial fibrillation patients with risk factors for stroke and systemic embolism require long-term anticoagulant therapy. Recently, non-vitamin K antagonist oral anticoagulant (NOAC) has shown their excellent safety and efficacy, and thus are widely accepted in clinical practice. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- NOAC monotherapy and Dual antithrombotic therapy with NOAC and clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Apr 2020to 8 May 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 19 years old
- Patient who underwent PCI with DES more than 12 months ago
- Non-valvular atrial fibrillation patients requiring long-term anticoagulation
Who cannot join
- Over 85 years old
- Pregnancy or Potential Pregnancy
- Life expectancy within 1 year
- Patients who refuse or do not understand the written consent form
- Requiring anticoagulation due to history of mechanical valve replacement, mitral stenosis or deep vein thrombosis
- Coagulopathy, continuous bleeding, or Hb level below 10 g/dL
Show all 10Show fewer
- Intracerebral hemorrhage within 2 months
- Patients with gastrointestinal hemorrhage within three months of registration
- Patients diagnosed with a gastrointestinal tumor that requires continuous treatment
- Patients treated with 1st generation drug-eluting stents (Cypher, Taxus, or Endeavor Sprint)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul
About this study
Official title: Appropriate Duration of Anti-Platelet and Thrombotic Strategy After 12 Months in Patients With Atrial Fibrillation Treated With Drug Eluting Stents (ADAPT AF-DES)
Atrial fibrillation patients with risk factors for stroke and systemic embolism require long-term anticoagulant therapy. Recently, non-vitamin K antagonist oral anticoagulant (NOAC) has shown their excellent safety and efficacy, and thus are widely accepted in clinical practice. Meanwhile, after percutaneous coronary intervention (PCI) using the drug-eluting stents due to coronary artery disease, the administration of one or more antiplatelets is essential to prevent the recurrence of stent thrombosis and myocardial infarction. Combined administration of anticoagulants and antiplatelets significantly lowers the incidence of ischemic events such as stroke and myocardial infarction, however, it also significantly increases the likelihood of bleeding leading to hospitalization, and or even death, thereby significantly affecting the clinical course of the AF patients who underwent PCI. Nevertheless, due to the very high mortality rate of stent thrombosis, the current standard of care guidelines recommend triple therapy with anticoagulants and double antiplatelet therapy (DAPT) in patients with atrial fibrillation for 1 month after coronary intervention, followed by co-administration of NOAC with single antiplatelet agent for 1 year. However, little is known after the optimal therapeutic strategy after 1 year. The purpose of this study is to compare the clinical results of single anticoagulant and clopidogrel combination therapy for maintenance therapy after 1 year in patients with atrial fibrillation.
Read the detailed description
AF patients who had undergone PCI with DES implantation at least 12 months ago will be enrolled in this study. Decision for the antiplatelet agent discontinuation would be determined by randomization. Apixaban or Rivaroxaban would be prescribed to reduce the risk stroke or systemic embolism evoked by AF, and the administration of Warfarin, a vitamin-K dependent anticoagulant, would also be allowed according to attending physician's decision. The following criteria should be followed for the reduction of dosages according to the patient's renal function and other systemic conditions. Warfarin is administered to patients with creatinine clearance < 15 ml/min or dialysis. The drugs used in this study correspond to the international treatment guidelines after coronary intervention in patients with atrial fibrillation.NOAC and antiplatelet agents would be prescribed upon an outpatient visit. Clinical outcome would be followed for 2 years after study enrollment and randomization.
Screening
- Baseline Serum AST/ALT level
- Creatinine clearance (mL/min)
- Concurrent administration of CYP3A4 agents: Ketoconazole, Itraconazole, Iopinavir/ritonavir, indinavir/ritonavir, conviaptan # Dose Adjustment Criteria for Apixaban @ Meeting 2 of 3 following criteria
- Serum creatinine level > 1.5 mg/dL
- Body weight under 60 kg
- age over 80 years old # Dose Adjustment Criteria for Rivaroxaban
- eGFR from 15-49 mg/min
- Conditions
- Atrial Fibrillation
- Being tested
- NOAC monotherapy, Dual antithrombotic therapy with NOAC and clopidogrel
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOAC monotherapyDrug
Patients enrolled in the NOAC monotherapy arm would be administered with apixaban 5 mg twice daily or rivaroxaban 20 mg once daily for 2 years after randomization. Reduced dose of apixaban (2.5 mg twice daily) or rivaroxaban (15 mg once daily) will be used in patients meeting the pre-defined criteria for dose reduction. Warfarin is allowed to use at the physicians' discretion.
Dual antithrombotic therapy with NOAC and clopidogrelDrug
Patients enrolled in the dual antithrombotic therapy arm would be administered with apixaban 5 mg twice daily or rivaroxaban 15 mg once daily and clopidogrel 75 mg daily for 2 years after randomization. Reduced dose of apixaban (2.5 mg twice daily) or rivaroxaban (10 mg once daily) will be used in patients meeting the pre-defined criteria for dose reduction. Warfarin is allowed to use at the physicians' discretion.
| Study group | Role | What they receive |
|---|---|---|
| NOAC monotherapy | Experimental | Not described Receives: Drug: NOAC monotherapy |
| Dual antithrombotic therapy | Active comparator | Not described Receives: Drug: Dual antithrombotic therapy with NOAC and clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net adverse clinical event (NACE)
All-cause death, myocardial infarction, stent thrombosis, stroke, systemic embolism, major or clinically relevant non-major bleeding defined by International Society on Thrombosis and Haemostasis (ISTH)
Measured: at 12 months (1 year)
Secondary outcomes (6)
Each component of NACE
- all-cause death; 2) myocardial infarction; 3) stent thrombosis; 4) stroke; 5) systemic embolism; 6) ISTH major bleeding; 7) ISTH clinically relevant non-major bleeding
Measured: Day 1 to 12 months (1 year)
ISTH major or clinically relevant non-major bleeding
Measured: Day 1 to 12 months (1 year)
All-cause death, myocardial infarction, stent thrombosis, stroke, systemic embolism, and ISTH major bleeding
Measured: Day 1 to 12 months (1 year)
Cardiovascular death
Measured: Day 1 to 12 months (1 year)
Cardiovascular death, myocardial infarction, stent thrombosis, ischemic stroke, and systemic embolism
Measured: Day 1 to 12 months (1 year)
Primary outcome (NACE) at 2 years
Measured: Day 1 to 24 months (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start28 Apr 2020
- Primary completion8 May 2026
- Study completion8 May 2026
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 Atrial FibrillationStudies 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
- Masking
- None (open label)
- Enrolment
- 960 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
- NCT04250116
- Sponsor's protocol ID
- 4-2019-1128
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2020
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data will be shared with the investigators and could be provided to outside researchers upon reasonable request.
Publications
Jeon HK, Jeon HS, Lee K, Cho YH, Choi CU, Lee SR, Park HB, Lee HC, Kim S, Lee SH, Lee YJ, Lee SJ, Yu HT, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Pak HN, Kim JS, Ahn SG; ADAPT AF-DES nvestigators. Antithrombotic Therapy in Patients With Atrial Fibrillation With Prior Complex PCI: A Secondary Analysis of the Randomized ADAPT AF-DES Trial. Circ Cardiovasc Interv. 2026 Jul 17:e016841. doi: 10.1161/CIRCINTERVENTIONS.126.016841. Online ahead of print.
PubMed 42464814Lee SJ, Yu HT, Lee YJ, Lee SH, Heo JH, Ahn SG, Shin S, Doh JH, Her AY, Cho BR, Kim GS, Kwon TG, Lim SW, Shim J, Jang JY, Lee K, Cho YH, Choi CU, Lee SR, Park HB, Lee HC, Kim S, Yun KH, Ahn JH, Lee BK, Cho DK, Kim SY, Kim U, Kang TS, Choi SH, Kim WH, Lee JB, Rhee MY, Kim JB, Jo SH, Hyun DW, Kim D, Kim TH, Hong SJ, Uhm JS, Shin DH, Ahn CM, Kim BK, Joung B, Ko YG, Choi D, Hong MK, Jang Y, Pak HN, Kim JS; ADAPT AF-DES Investigators. Therapy for Atrial Fibrillation in Patients with Drug-Eluting Stents. N Engl J Med. 2026 Feb 12;394(7):658-668. doi: 10.1056/NEJMoa2512091. Epub 2025 Nov 8.
PubMed 41211917Lee SH, Lee SJ, Heo JH, Ahn SG, Doh JH, Shin S, Shim J, Her AY, Kim BG, Lim SW, Kwon TG, Lee KH, Kim D, Lee YJ, Yu HT, Kim TH, Shin DH, Pak HN, Kim JS. Optimal antithrombotic strategy in patients with atrial fibrillation beyond 1 year after drug-eluting stent implantation: Design and rationale of the randomized ADAPT AF-DES trial. Am Heart J. 2024 May;271:48-54. doi: 10.1016/j.ahj.2024.02.014. Epub 2024 Feb 23.
PubMed 38401647
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Duration of Anti-Platelet and Thrombotic Strategy After 12 Months in Patients With Atrial Fibrillation Treated With Drug Eluting Stents (ADAPT AF-DES)
- ClinicalTrials.gov ID
- NCT04250116
- Acronym / sponsor ID
- 4-2019-1128
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 960 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 8 May 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 31 Jan 2020 (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.
Atrial fibrillation patients with risk factors for stroke and systemic embolism require long-term anticoagulant therapy. Recently, non-vitamin K antagonist oral anticoagulant (NOAC) has shown their excellent safety and efficacy, and thus are widely accepted in clinical practice. Meanwhile, after percutaneous coronary intervention (PCI) using the drug-eluting stents due to coronary artery disease, the administration of one or more antiplatelets is essential to prevent the recurrence of stent thrombosis and myocardial infarction. Combined administration of anticoagulants and antiplatelets significantly lowers the incidence of ischemic events such as stroke and myocardial infarction, however, it also significantly increases the likelihood of bleeding leading to hospitalization, and or even death, thereby significantly affecting the clinical course of the AF patients who underwent PCI. Nevertheless, due to the very high mortality rate of stent thrombosis, the current standard of care guidelines recommend triple therapy with anticoagulants and double antiplatelet therapy (DAPT) in patients with atrial fibrillation for 1 month after coronary intervention, followed by co-administration of NOAC with single antiplatelet agent for 1 year. However, little is known after the optimal therapeutic strategy after 1 year. The purpose of this study is to compare the clinical results of single anticoagulant and clopidogrel combination therapy for maintenance therapy after 1 year in patients with atrial fibrillation.
Detailed description
AF patients who had undergone PCI with DES implantation at least 12 months ago will be enrolled in this study. Decision for the antiplatelet agent discontinuation would be determined by randomization. Apixaban or Rivaroxaban would be prescribed to reduce the risk stroke or systemic embolism evoked by AF, and the administration of Warfarin, a vitamin-K dependent anticoagulant, would also be allowed according to attending physician's decision. The following criteria should be followed for the reduction of dosages according to the patient's renal function and other systemic conditions. Warfarin is administered to patients with creatinine clearance < 15 ml/min or dialysis. The drugs used in this study correspond to the international treatment guidelines after coronary intervention in patients with atrial fibrillation.NOAC and antiplatelet agents would be prescribed upon an outpatient visit. Clinical outcome would be followed for 2 years after study enrollment and randomization.
Screening
- Baseline Serum AST/ALT level
- Creatinine clearance (mL/min)
- Concurrent administration of CYP3A4 agents: Ketoconazole, Itraconazole, Iopinavir/ritonavir, indinavir/ritonavir, conviaptan # Dose Adjustment Criteria for Apixaban @ Meeting 2 of 3 following criteria
- Serum creatinine level > 1.5 mg/dL
- Body weight under 60 kg
- age over 80 years old # Dose Adjustment Criteria for Rivaroxaban
- eGFR from 15-49 mg/min
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOAC monotherapy | Experimental | Drug: NOAC monotherapy |
| Dual antithrombotic therapy | Active comparator | Drug: Dual antithrombotic therapy with NOAC and clopidogrel |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over 19 years old
- Patient who underwent PCI with DES more than 12 months ago
- Non-valvular atrial fibrillation patients requiring long-term anticoagulation
Key exclusion criteria (10 listed)
- Over 85 years old
- Pregnancy or Potential Pregnancy
- Life expectancy within 1 year
- Patients who refuse or do not understand the written consent form
- Requiring anticoagulation due to history of mechanical valve replacement, mitral stenosis or deep vein thrombosis
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 |
|---|---|---|
| NOAC monotherapyPatients enrolled in the NOAC monotherapy arm would be administered with apixaban 5 mg twice daily or rivaroxaban 20 mg once daily for 2 years after randomization. Reduced dose of apixaban (2.5 mg twice daily) or rivaroxaban (15 mg once daily) will be used in patients meeting the pre-defined criteria for dose reduction. Warfarin is allowed to use at the physicians' discretion. | Drug | NOAC monotherapy |
| Dual antithrombotic therapy with NOAC and clopidogrelPatients enrolled in the dual antithrombotic therapy arm would be administered with apixaban 5 mg twice daily or rivaroxaban 15 mg once daily and clopidogrel 75 mg daily for 2 years after randomization. Reduced dose of apixaban (2.5 mg twice daily) or rivaroxaban (10 mg once daily) will be used in patients meeting the pre-defined criteria for dose reduction. Warfarin is allowed to use at the physicians' discretion. | Drug | Dual antithrombotic therapy |
Primary outcome
Net adverse clinical event (NACE)
Time frame: at 12 months (1 year)
All-cause death, myocardial infarction, stent thrombosis, stroke, systemic embolism, major or clinically relevant non-major bleeding defined by International Society on Thrombosis and Haemostasis (ISTH)
6 secondary outcomes
Each component of NACE
Time frame: Day 1 to 12 months (1 year)
ISTH major or clinically relevant non-major bleeding
Time frame: Day 1 to 12 months (1 year)
All-cause death, myocardial infarction, stent thrombosis, stroke, systemic embolism, and ISTH major bleeding
Time frame: Day 1 to 12 months (1 year)
Cardiovascular death
Time frame: Day 1 to 12 months (1 year)
Cardiovascular death, myocardial infarction, stent thrombosis, ischemic stroke, and systemic embolism
Time frame: Day 1 to 12 months (1 year)
Primary outcome (NACE) at 2 years
Time frame: Day 1 to 24 months (2 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Derived from this study: PubMed 42464814Jeon HK, Jeon HS, Lee K, Cho YH, Choi CU, Lee SR, Park HB, Lee HC, Kim S, Lee SH, Lee YJ, Lee SJ, Yu HT, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Pak HN, Kim JS, Ahn SG; ADAPT AF-DES nvestigators. Antithrombotic Therapy in Patients With Atrial Fibrillation With Prior Complex PCI: A Secondary Analysis of the Randomized ADAPT AF-DES Trial. Circ Cardiovasc Interv. 2026 Jul 17:e016841. doi: 10.1161/CIRCINTERVENTIONS.126.016841. Online ahead of print.
- Derived from this study: PubMed 41211917Lee SJ, Yu HT, Lee YJ, Lee SH, Heo JH, Ahn SG, Shin S, Doh JH, Her AY, Cho BR, Kim GS, Kwon TG, Lim SW, Shim J, Jang JY, Lee K, Cho YH, Choi CU, Lee SR, Park HB, Lee HC, Kim S, Yun KH, Ahn JH, Lee BK, Cho DK, Kim SY, Kim U, Kang TS, Choi SH, Kim WH, Lee JB, Rhee MY, Kim JB, Jo SH, Hyun DW, Kim D, Kim TH, Hong SJ, Uhm JS, Shin DH, Ahn CM, Kim BK, Joung B, Ko YG, Choi D, Hong MK, Jang Y, Pak HN, Kim JS; ADAPT AF-DES Investigators. Therapy for Atrial Fibrillation in Patients with Drug-Eluting Stents. N Engl J Med. 2026 Feb 12;394(7):658-668. doi: 10.1056/NEJMoa2512091. Epub 2025 Nov 8.
- Derived from this study: PubMed 38401647Lee SH, Lee SJ, Heo JH, Ahn SG, Doh JH, Shin S, Shim J, Her AY, Kim BG, Lim SW, Kwon TG, Lee KH, Kim D, Lee YJ, Yu HT, Kim TH, Shin DH, Pak HN, Kim JS. Optimal antithrombotic strategy in patients with atrial fibrillation beyond 1 year after drug-eluting stent implantation: Design and rationale of the randomized ADAPT AF-DES trial. Am Heart J. 2024 May;271:48-54. doi: 10.1016/j.ahj.2024.02.014. Epub 2024 Feb 23.
- Individual participant dataSharing planned: Yes. Individual patient data will be shared with the investigators and could be provided to outside researchers upon reasonable request.
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Atrial Fibrillation (AF)
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 NOAC monotherapy and Dual antithrombotic therapy with NOAC and clopidogrel in people with Atrial Fibrillation, 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 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: finished, as of the sponsor's last update on 4 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 event (NACE) (time frame: at 12 months (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 NCT04250116, 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 Sep 2026.