NCT04250116

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
960

participants targeted

Target at P75+ for phase_4 atrial-fibrillation

Timeline
Completed

Started Apr 2020

Longer than P75 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

April 28, 2020

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

4.9 years

First QC Date

January 19, 2020

Last Update Submit

January 20, 2025

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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)

    at 12 months (1 year)

Secondary Outcomes (6)

  • Each component of NACE

    Day 1 to 12 months (1 year)

  • ISTH major or clinically relevant non-major bleeding

    Day 1 to 12 months (1 year)

  • All-cause death, myocardial infarction, stent thrombosis, stroke, systemic embolism, and ISTH major bleeding

    Day 1 to 12 months (1 year)

  • Cardiovascular death

    Day 1 to 12 months (1 year)

  • Cardiovascular death, myocardial infarction, stent thrombosis, ischemic stroke, and systemic embolism

    Day 1 to 12 months (1 year)

  • +1 more secondary outcomes

Study Arms (2)

NOAC monotherapy

EXPERIMENTAL
Drug: NOAC monotherapy

Dual antithrombotic therapy

ACTIVE COMPARATOR
Drug: Dual antithrombotic therapy with NOAC and clopidogrel

Interventions

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.

NOAC monotherapy
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.

Dual antithrombotic therapy

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, South Korea

Location

Related Publications (2)

  • Lee 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. 2025 Nov 8. doi: 10.1056/NEJMoa2512091. Online ahead of print.

    PMID: 41211917DERIVED

  • Lee 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.

    PMID: 38401647DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

N(4)-oleylcytosine arabinosideClopidogrel

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2020

First Posted

January 31, 2020

Study Start

April 28, 2020

Primary Completion

April 1, 2025

Study Completion

April 1, 2026

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)