Atrial FibrillationADAPT AFFIRMNCT06866665
Antithrombotic Strategy for AF Patients With High Risk CAD
A study testing Anticoagulation Monotherapy and Combination therapy in people with Atrial Fibrillation and Coronary Artery Disease, run by Yonsei University.
Trial summary
Anticoagulation therapy is recommended for patients with atrial fibrillation (AF) in order to prevent ischemic stroke and systemic embolism. Meanwhile, lifelong antiplatelet therapy is highly recommended to prevent stent thrombosis and further ischemic adverse events after percutaneous coronary intervention (PCI) with… Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Atrial Fibrillation, Coronary Artery Disease
- What is being tested?
- Anticoagulation Monotherapy and Combination therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Dec 2030
- Phase
- Interventional
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 19 years old
- Presence of AF with CHA2DS2-VASc score ≥ 2
- Patients with stable CAD - a history of percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) before 6 months (chronic coronary syndrome) or 12 months (acute coronary syndrome); anatomically confirmed CAD on coronary angiography or computed tomography scan
- Presence of an excessive ischemic risk i. A history of myocardial infarction (MI) ii. Complex PCI iii. Untreated lesion with >50% stenosis at major epicardial vessel after coronary revascularization iv. Untreated multivessel CAD (>50% stenosis of >1 major epicardial vessel or left main stem) v. Peripheral artery disease vi. Cerebrovascular disease
Who cannot join
- >85 years old.
- Patients who received PCI or CABG within 6 months.
- Patients with a history of acute coronary syndrome within 12 months.
- Patients who require anticoagulation with warfarin due to a mechanical prosthetic valve, or ≥ moderate mitral stenosis.
- Patients with a comorbidity requiring anticoagulation other than AF.
- Patients who is not able to receive apixaban or clopidogrel due to previous adverse reaction.
Show all 13Show fewer
- Patients who have coagulopathy or have a history of recurrent bleeding.
- Intracranial or gastrointestinal bleeding within 3 months.
- Gastrointestinal tumor requiring treatment.
- Patients who are pregnant or those who report potential pregnancy.
- Life expectancy < 1 year due to malignancy.
- Refuse or enable to understand the written informed consent.
- Patiens who are not able to discontinue a drug related to CYP3A4 inhibition.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ADequate AntiPlatelet and Anticoagulation Therapy in Atrial Fibrillation Patients With Focus on Ischemic Risk Management A Randomized ADAPT AFFIRM Study
Anticoagulation therapy is recommended for patients with atrial fibrillation (AF) in order to prevent ischemic stroke and systemic embolism. Meanwhile, lifelong antiplatelet therapy is highly recommended to prevent stent thrombosis and further ischemic adverse events after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. In this context, in patients with AF undergoing DES implantation, anticoagulation and antiplatelet therapies perform their own unique roles. However, the current guidelines recommend to discontinue this antiplatelet agent beyond 1 year due to an excessive bleeding risk derived from DAT.
The Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease (AFIRE) emphasized that bleeding risk derived from rivaroxaban-based DAT may outweigh ischemic risk derived from antiplatelet discontinuation in patients with AF and stable coronary artery disease. Furthermore, the recent Edoxaban versus Edoxaban with Antiplatelet Agent in Patients with Atrial Fibrillation and Chronic Stable Coronary Artery Disease (EPIC-CAD) trial also demonstrated that edoxaban monotherapy led to a lower net adverse event compared to than edoxaban-based DAT.
Although these studies strongly supported the benefit of antiplatelet discontinuation in AF patients with stable coronary artery disease, many physicians still hesitate to discontinue antiplatelet agents even 1 year after DES implantation because of concerns regarding stent thrombosis or subsequent myocardial infarction (MI). This concern is exacerbated in patients with an excessive ischemic risk, such as those who received complex PCI or those with polyvascular disease. To address this disparity between clinical practice and recommendations based on the guidelines, the Adequate Antiplatelet and Anticoagulation Therapy in Atrial Fibrillation Patients with Focus on Ischemic Risk Management (ADAPT AFFIRM) trial is designed to elucidate the efficacy and safety of apixaban monotherapy versus apixaban plus clopidogrel combination therapy as a chronic maintenance strategy in AF patients with stable coronary artery disease and excessive ischemic risk.
Read the detailed description
Investigators will recruit 1400 patients with atrial fibrillation (AF) and coronary artery disease (CAD) with high ischemic risk. High ischemic risk is defined as acute myocardial infarction, complex percutaneous coronary intervention (PCI), untreated significant coronary stenosis, or polyvascular disease. Paticipants will be randomly assigned to either anticoagulation monotherapy group or combination therapy group. Participants assigned to the anticoagulation monotherapy group wil receive apixaban 5 mg twice daily (or reduced dose as judged by investigators) and those assigned to the combination therapy group will receive additional clopidogrel 75 mg daily on top of apixaban. Net adverse clinical events comprising all-cause death, myocardial infarction, stroke, systemic embolism, or ISTH major or clinically relevant non-major bleeding events will be evaluated at 12 months after randomization. Included participant will be followed up until the last participant will be followed up for at lease 12 months.
- Conditions
- Atrial Fibrillation, Coronary Artery Disease
- Being tested
- Anticoagulation Monotherapy, Combination therapy
- Keywords
- Atrial fibrillation, complex PCI, polyvascular disease, antithrombotic strategy
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulation MonotherapyDrug
Also called Apixaban monotherapy
Participants in the anticoagulation monotherapy group will receive apixaban 5 mg twice daily during the study period.
Combination therapyDrug
Also called Apixaban and clopidogrel combination therapy
Participants in the combination therapy group will receive clopiogrel 75 mg daily and apixaban 5 mg twice daily during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulation Monotherapy | Active comparator | Participants receiving anticoagulation monotherapy Receives: Drug: Anticoagulation Monotherapy |
| Combination therapy | Experimental | Particiapnts receiving anticoagulation therapy with additional clopidogrel Receives: Drug: Combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net adverse clinical event (NACE)
NACE is defined as a composite of all-cause death, MI, stroke, systemic embolism, and major or clinically relevant non-major (CRNM) bleeding as defined by International Society on Thrombosis and Hemostasis (ISTH) criteria.
Measured: 12 months after the last enrollment
Secondary outcomes (19)
Composite bleeding event
Composite bleeding event: a composite of ISTH major or CRNM bleeding
Measured: 12 months after the last enrollment
Major adverse cardiac event
Major adverse cardiac event (MACE): a composite of cardiovascular death, MI, or any coronary revascularization
Measured: 12 months after the last enrollment
Key ischemic event
Key ischemic event: a composite of cardiovascular death, MI, ischemic stroke, or systemic embolism
Measured: 12 months after the last enrollment
Each components of NACE
all-cause death
Measured: 12 months after the last enrollment
Cardiovascular death
Measured: 12 months after the last enrollment
Non-cardiovascular death
Measured: 12 months after the last enrollment
Ischemic stroke
Measured: 12 months after the last enrollment
Hemorrhagic stroke
Measured: 12 months after the last enrollment
Any coronary revascularization
PCI (Percutaneous Coronary Intervention), CABG(Coronary Artery Bypass Graft)
Measured: 12 months after the last enrollment
Acute limb ischemia
Measured: 12 months after the last enrollment
Any limb revascularization or amputation
- Endovascular revascularization
- Surgical revascularization
- Amputation
Measured: 12 months after the last enrollment
Any intracranial revascularization
- Endovascular revascularization
- Surgical revascularization
Measured: 12 months after the last enrollment
A composite of cardiovascular death, MI, acute limb ischemic, or any limb revascularization or amputation
Measured: 12 months after the last enrollment
A composite of cardiovascular death, MI, acute limb ischemia, or ischemic stroke
Measured: 12 months after the last enrollment
Each components of NACE
stroke
Measured: 12 months after the last enrollment
Each components of NACE
systemic embolism
Measured: 12 months after the last enrollment
Each components of NACE
ISTH major bleeding
Measured: 12 months after the last enrollment
Each components of NACE
ISTH CRNM bleeding
Measured: 12 months after the last enrollment
Each components of NACE
MI
Measured: 12 months after the last enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 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
- NCT06866665
- Sponsor's protocol ID
- 4-2024-1325
- Acronym
- ADAPT AFFIRM
- Status last verified
- Mar 2025
- First submitted
- 23 Feb 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADequate AntiPlatelet and Anticoagulation Therapy in Atrial Fibrillation Patients With Focus on Ischemic Risk Management A Randomized ADAPT AFFIRM Study
- ClinicalTrials.gov ID
- NCT06866665
- Acronym / sponsor ID
- ADAPT AFFIRM / 4-2024-1325
- Conditions
- Atrial Fibrillation, Coronary Artery Disease
- Keywords
- Atrial fibrillation, complex PCI, polyvascular disease, antithrombotic strategy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 10 Mar 2025 (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.
Anticoagulation therapy is recommended for patients with atrial fibrillation (AF) in order to prevent ischemic stroke and systemic embolism. Meanwhile, lifelong antiplatelet therapy is highly recommended to prevent stent thrombosis and further ischemic adverse events after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. In this context, in patients with AF undergoing DES implantation, anticoagulation and antiplatelet therapies perform their own unique roles. However, the current guidelines recommend to discontinue this antiplatelet agent beyond 1 year due to an excessive bleeding risk derived from DAT.
The Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease (AFIRE) emphasized that bleeding risk derived from rivaroxaban-based DAT may outweigh ischemic risk derived from antiplatelet discontinuation in patients with AF and stable coronary artery disease. Furthermore, the recent Edoxaban versus Edoxaban with Antiplatelet Agent in Patients with Atrial Fibrillation and Chronic Stable Coronary Artery Disease (EPIC-CAD) trial also demonstrated that edoxaban monotherapy led to a lower net adverse event compared to than edoxaban-based DAT.
Although these studies strongly supported the benefit of antiplatelet discontinuation in AF patients with stable coronary artery disease, many physicians still hesitate to discontinue antiplatelet agents even 1 year after DES implantation because of concerns regarding stent thrombosis or subsequent myocardial infarction (MI). This concern is exacerbated in patients with an excessive ischemic risk, such as those who received complex PCI or those with polyvascular disease. To address this disparity between clinical practice and recommendations based on the guidelines, the Adequate Antiplatelet and Anticoagulation Therapy in Atrial Fibrillation Patients with Focus on Ischemic Risk Management (ADAPT AFFIRM) trial is designed to elucidate the efficacy and safety of apixaban monotherapy versus apixaban plus clopidogrel combination therapy as a chronic maintenance strategy in AF patients with stable coronary artery disease and excessive ischemic risk.
Detailed description
Investigators will recruit 1400 patients with atrial fibrillation (AF) and coronary artery disease (CAD) with high ischemic risk. High ischemic risk is defined as acute myocardial infarction, complex percutaneous coronary intervention (PCI), untreated significant coronary stenosis, or polyvascular disease. Paticipants will be randomly assigned to either anticoagulation monotherapy group or combination therapy group. Participants assigned to the anticoagulation monotherapy group wil receive apixaban 5 mg twice daily (or reduced dose as judged by investigators) and those assigned to the combination therapy group will receive additional clopidogrel 75 mg daily on top of apixaban. Net adverse clinical events comprising all-cause death, myocardial infarction, stroke, systemic embolism, or ISTH major or clinically relevant non-major bleeding events will be evaluated at 12 months after randomization. Included participant will be followed up until the last participant will be followed up for at lease 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anticoagulation Monotherapy | Active comparator | Drug: Anticoagulation MonotherapyParticipants receiving anticoagulation monotherapy |
| Combination therapy | Experimental | Drug: Combination therapyParticiapnts receiving anticoagulation therapy with additional clopidogrel |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 19 years old
- Presence of AF with CHA2DS2-VASc score ≥ 2
- Patients with stable CAD - a history of percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) before 6 months (chronic coronary syndrome) or 12 months (acute coronary syndrome); anatomically confirmed CAD on coronary angiography or computed tomography scan
- Presence of an excessive ischemic risk i. A history of myocardial infarction (MI) ii. Complex PCI iii. Untreated lesion with >50% stenosis at major epicardial vessel after coronary revascularization iv. Untreated multivessel CAD (>50% stenosis of >1 major epicardial vessel or left main stem) v. Peripheral artery disease vi. Cerebrovascular disease
Key exclusion criteria (13 listed)
- >85 years old.
- Patients who received PCI or CABG within 6 months.
- Patients with a history of acute coronary syndrome within 12 months.
- Patients who require anticoagulation with warfarin due to a mechanical prosthetic valve, or ≥ moderate mitral stenosis.
- Patients with a comorbidity requiring anticoagulation other than AF.
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 |
|---|---|---|
| Anticoagulation MonotherapyAlso: Apixaban monotherapyParticipants in the anticoagulation monotherapy group will receive apixaban 5 mg twice daily during the study period. | Drug | Anticoagulation Monotherapy |
| Combination therapyAlso: Apixaban and clopidogrel combination therapyParticipants in the combination therapy group will receive clopiogrel 75 mg daily and apixaban 5 mg twice daily during the study period. | Drug | Combination therapy |
Primary outcome
Net adverse clinical event (NACE)
Time frame: 12 months after the last enrollment
NACE is defined as a composite of all-cause death, MI, stroke, systemic embolism, and major or clinically relevant non-major (CRNM) bleeding as defined by International Society on Thrombosis and Hemostasis (ISTH) criteria.
19 secondary outcomes
Composite bleeding event
Time frame: 12 months after the last enrollment
Major adverse cardiac event
Time frame: 12 months after the last enrollment
Key ischemic event
Time frame: 12 months after the last enrollment
Each components of NACE
Time frame: 12 months after the last enrollment
Cardiovascular death
Time frame: 12 months after the last enrollment
Non-cardiovascular death
Time frame: 12 months after the last enrollment
Ischemic stroke
Time frame: 12 months after the last enrollment
Hemorrhagic stroke
Time frame: 12 months after the last enrollment
Any coronary revascularization
Time frame: 12 months after the last enrollment
Acute limb ischemia
Time frame: 12 months after the last enrollment
Any limb revascularization or amputation
Time frame: 12 months after the last enrollment
Any intracranial revascularization
Time frame: 12 months after the last enrollment
A composite of cardiovascular death, MI, acute limb ischemic, or any limb revascularization or amputation
Time frame: 12 months after the last enrollment
A composite of cardiovascular death, MI, acute limb ischemia, or ischemic stroke
Time frame: 12 months after the last enrollment
Each components of NACE
Time frame: 12 months after the last enrollment
Each components of NACE
Time frame: 12 months after the last enrollment
Each components of NACE
Time frame: 12 months after the last enrollment
Each components of NACE
Time frame: 12 months after the last enrollment
Each components of NACE
Time frame: 12 months after the last enrollment
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 14 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Anticoagulation Monotherapy and Combination therapy in people with Atrial Fibrillation and Coronary Artery Disease, run by Yonsei University.
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 13 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 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact jung sun Kim, MD,PhD (+82-2-2228-8457, KJS1218@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net adverse clinical event (NACE) (time frame: 12 months after the last enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2025.