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

  • STATUS
    Recruiting
  • End date
    Dec 25, 2024
  • participants needed
    960
  • sponsor
    Yonsei University
Updated on 25 January 2021
stroke
warfarin
anticoagulants
infarct
antiplatelet agents
fibrillation
vitamin k antagonist
anticoagulant therapy
noac
vitamin k
apixaban
embolism
anticoagulation therapy

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.

Description

Atrial fibrillation(AF) patients who had undergone PCI with DES implantation at 12-18 months ago will be enrolled in this study. Decision for the antiplatelet agent discontinuation would be determined by randomization. Apixaban would be prescribed to reduced 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 of 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 reduction (patients meeting both criteria would be prescribed with Apixaban 2.5 mb bid)

  • 15 mL/min eGFR < 30 mL/min
  • ESRD patients under 60 kg of bodyweight or age over 80 years old.

Details
Condition Arrhythmia, Atrial Fibrillation, Atrial Fibrillation (Pediatric), Dysrhythmia
Treatment Apixaban monotherapy, Dual therapy with apixaban and clopidogrel
Clinical Study IdentifierNCT04250116
SponsorYonsei University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 19 yrs and 85 yrs?
Gender: Male or Female
Do you have any of these conditions: Atrial Fibrillation or Dysrhythmia or Atrial Fibrillation (Pediatric) or Arrhythmia?
Do you have any of these conditions: Dysrhythmia or Atrial Fibrillation (Pediatric) or Arrhythmia or Atrial Fibrillation?
over 19 years old
Patient who underwent PCI with DES 12 months to 18 months ago
Non-valvular atrial fibrillation patients requiring long-term anticoagulation

Exclusion Criteria

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 bleeidng, 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
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