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NCT Number: NCT04250116

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • over 19 years old
  • Patient who underwent PCI with DES more than 12 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 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)

Treatment and study plan

NOAC monotherapy

Drug

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.

Dual antithrombotic therapy with NOAC and clopidogrel

Drug

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Each component of NACE

    Time frame: Day 1 to 12 months (1 year)

    • 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

  2. ISTH major or clinically relevant non-major bleeding

    Time frame: Day 1 to 12 months (1 year)

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

    Time frame: Day 1 to 12 months (1 year)

  4. Cardiovascular death

    Time frame: Day 1 to 12 months (1 year)

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

    Time frame: Day 1 to 12 months (1 year)

  6. Primary outcome (NACE) at 2 years

    Time frame: Day 1 to 24 months (2 years)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jan 31, 2020
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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