Antithrombotic Strategy for AF Patients With High Risk CAD

NCT06866665 | Not Yet Recruiting DMC

• 1 other identifier: 4-2024-1325
• Study Type: interventional
• Target: 1,400
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Atrial Fibrillation; Coronary Artery Disease

Keywords

Atrial fibrillation; complex PCI; polyvascular disease; antithrombotic strategy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after the last enrollment

Secondary Outcomes (19)

• Composite bleeding event

  12 months after the last enrollment

• Major adverse cardiac event

  12 months after the last enrollment

• Key ischemic event

  12 months after the last enrollment

• Each components of NACE

  12 months after the last enrollment

• Cardiovascular death

  12 months after the last enrollment

Study Arms (2)

Anticoagulation Monotherapy

ACTIVE COMPARATOR

Participants receiving anticoagulation monotherapy

Drug: Anticoagulation Monotherapy

Combination therapy

EXPERIMENTAL

Particiapnts receiving anticoagulation therapy with additional clopidogrel

Drug: Combination therapy

Interventions

Anticoagulation Monotherapy DRUG

Participants in the anticoagulation monotherapy group will receive apixaban 5 mg twice daily during the study period.

Also known as: Apixaban monotherapy

Anticoagulation Monotherapy

Combination therapy DRUG

Participants in the combination therapy group will receive clopiogrel 75 mg daily and apixaban 5 mg twice daily during the study period.

Also known as: Apixaban and clopidogrel combination therapy

Combination therapy

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• \>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.
• 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.

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Conditions

Atrial Fibrillation; Coronary Artery Disease

Interventions

Combined Modality Therapy; apixaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

jung sun Kim, MD,PhD

CONTACT

+82-2-2228-8457; KJS1218@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 10, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 14, 2025

Record last verified: 2025-03