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

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ClinicalTrials.gov Identifier: NCT04250116
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Apixaban monotherapy Drug: Dual therapy with apixaban and clopidogrel Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Appropriate Duration of Anti-Platelet and Thrombotic Strategy After 12 Months in Patients With Atrial Fibrillation Treated With Drug Eluting Stents
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anticoagulation mono therapy
Apixaban monotherapy
Drug: Apixaban monotherapy
Patients enrolled in the anticoagulation mono therapy arm would be administered with apixaban 5 mg twice daily for 2 years after randomization. In case of renal impairment, reduced dose of apixaban (2.5 mg twice daily) or Warfarin would be considered.

Active Comparator: Dual antithrombotic therapy Drug: Dual therapy with apixaban and clopidogrel
Patients enrolled in the dual antithrombotic therapy arm would be administered with apixaban 5 mg twice daily and clopidogrel 75 mg daily for 2 years after randomization. In case of renal impairment, reduced dose of apixaban (2.5 mg twice daily) or Warfarin would be considered.




Primary Outcome Measures :
  1. Net adverse clinical event (NACE) [ Time Frame: Day 1 to 24 months (2 years) ]
    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 Outcome Measures :
  1. Incidence of each component of NACE [ Time Frame: Day 1 to 24 months (2 years) ]
    -NACE includes all-cause death, myocardial infarction, definite, probable, or possible stent thrombosis, stroke, systemic embolism, and ISTH major or clinically relevant non-major bleeding

  2. Major or clinically relevant non-major bleeding defined by International Society on Thrombosis and Haemostasis (ISTH) [ Time Frame: Day 1 to 24 months (2 years) ]
  3. NACE or ISTH clinically relevant non-major bleeding [ Time Frame: Day 1 to 24 months (2 years) ]
    -NACE includes all-cause death, myocardial infarction, definite, probable, or possible stent thrombosis, stroke, systemic embolism, and ISTH major or clinically relevant non-major bleeding

  4. All-cause or cardiovascular death [ Time Frame: Day 1 to 24 months (2 years) ]
  5. Major adverse cardiac event (MACE) [ Time Frame: Day 1 to 24 months (2 years) ]
    -MACE includes all-cause death, myocardial infarction, definite, probable, or possible stent thrombosis, ischemic stroke, and systemic embolism



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. over 19 years old
  2. Patient who underwent PCI with DES 12 months to 18 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 bleeidng, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250116


Contacts
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Contact: Jung-Sun Kim 82-2-2228-8457 KJS1218@yuhs.ac

Locations
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Korea, Republic of
Severance Cardiovascular Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of
Contact: Jung-Sun Kim    82-2-2228-8457    KJS1218@yuhs.ac   
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04250116    
Other Study ID Numbers: 4-2019-1128
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Apixaban
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anticoagulants