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NCT04250116CompletedPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 4 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
960 (actual)
First submitted
19 Jan 2020
Start date
28 Apr 2020
Primary completion date
8 May 2026
Lead sponsor
Yonsei University
NCT number
NCT04250116

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 960
  • From 28 Apr 2020 to the primary completion date, 8 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients treated with 1st generation drug-eluting stents (Cypher, Taxus, or Endeavor Sprint)

Other illness

  • Requiring anticoagulation due to history of mechanical valve replacement, mitral stenosis or deep vein thrombosis
  • Intracerebral hemorrhage within 2 months
  • Patients with gastrointestinal hemorrhage within three months of registration

Lab values

  • Coagulopathy, continuous bleeding, or Hb level below 10 g/dL

Age

  • Over 85 years old

Other

  • Pregnancy or Potential Pregnancy
  • Life expectancy within 1 year
  • Patients who refuse or do not understand the written consent form
  • Patients diagnosed with a gastrointestinal tumor that requires continuous treatment

Who the study is looking for

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

Age in the registry: 19 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Severance Cardiovascular Hospital, Yonsei University Health System
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.