Appropriate Duration of Anti-Platelet and Thrombotic Strategy After 12 Months in Patients With Atrial Fibrillation Treated With Drug Eluting Stents

September 1, 2026 updated by: Yonsei University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

960

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Severance Cardiovascular Hospital, Yonsei University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. over 19 years old
  2. Patient who underwent PCI with DES more than 12 months ago
  3. Non-valvular atrial fibrillation patients requiring long-term anticoagulation

Exclusion Criteria:

  1. Over 85 years old
  2. Pregnancy or Potential Pregnancy
  3. Life expectancy within 1 year
  4. Patients who refuse or do not understand the written consent form
  5. Requiring anticoagulation due to history of mechanical valve replacement, mitral stenosis or deep vein thrombosis
  6. Coagulopathy, continuous bleeding, or Hb level below 10 g/dL
  7. Intracerebral hemorrhage within 2 months
  8. Patients with gastrointestinal hemorrhage within three months of registration
  9. Patients diagnosed with a gastrointestinal tumor that requires continuous treatment
  10. Patients treated with 1st generation drug-eluting stents (Cypher, Taxus, or Endeavor Sprint)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dual antithrombotic therapy
Drug: Dual antithrombotic therapy with NOAC and clopidogrel
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.
Experimental: NOAC monotherapy
Drug: NOAC monotherapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at 12 months (1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Each component of NACE
Time Frame: Day 1 to 12 months (1 year)
1) 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
Day 1 to 12 months (1 year)
ISTH major or clinically relevant non-major bleeding
Time Frame: Day 1 to 12 months (1 year)
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)
Day 1 to 12 months (1 year)
Cardiovascular death
Time Frame: Day 1 to 12 months (1 year)
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)
Day 1 to 12 months (1 year)
Primary outcome (NACE) at 2 years
Time Frame: Day 1 to 24 months (2 years)
Day 1 to 24 months (2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2020

Primary Completion (Actual)

May 8, 2026

Study Completion (Actual)

May 8, 2026

Study Registration Dates

First Submitted

January 19, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 31, 2020

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2019-1128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual patient data will be shared with the investigators and could be provided to outside researchers upon reasonable request.

IPD Sharing Time Frame

Data will be available beginning in November 2026 and will remain available for 5 years.

IPD Sharing Access Criteria

De-identified IPD will be made available to qualified researchers with a scientifically sound research proposal. Requests should include the research objectives, study design, statistical analysis plan, and intended use of the data. Requests will be reviewed by the study investigators. Data may be shared for approved research purposes, including pooled analyses, meta-analyses, and other secondary analyses, following approval and execution of an appropriate data use agreement, where applicable.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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