Appropriate Duration of Anti-Platelet and Thrombotic Strategy After 12 Months in Patients With Atrial Fibrillation Treated With Drug Eluting Stents
Study Details
Study Description
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 |
|---|---|---|
|
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
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Baseline Serum AST/ALT level
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Creatinine clearance (mL/min)
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Concurrent administration of CYP3A4 agents: Ketoconazole, Itraconazole, Iopinavir/ritonavir, indinavir/ritonavir, conivaptan
Dose reduction (patients meeting both criteria would be prescribed with Apixaban 2.5 mb bid)
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15 mL/min ≤ eGFR < 30 mL/min
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ESRD patients under 60 kg of bodyweight or age over 80 years old.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Anticoagulation mono therapy
|
Drug: NOAC monotherapy
Patients enrolled in the anticoagulation mono therapy arm would be administered with apixaban 5 mg twice daily or rivaroxaban 20 mg once daily for 2 years after randomization. In case of renal impairment, reduced dose of apixaban (2.5 mg twice daily) or rivaroxaban (15 mg once daily) or Warfarin would be considered.
|
| Active Comparator: Dual antithrombotic therapy
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Drug: Dual therapy with apixaban and clopidogrel
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. In case of renal impairment, reduced dose of apixaban (2.5 mg twice daily) or rivaroxaban (10 mg once daily) or Warfarin would be considered.
|
Outcome Measures
Primary Outcome Measures
- Net adverse clinical event (NACE) [at 12 months (1 year) and 24 months (2 years) after enrollment.]
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
- Incidence of each component of NACE [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
- Major or clinically relevant non-major bleeding defined by International Society on Thrombosis and Haemostasis (ISTH) [Day 1 to 24 months (2 years)]
- NACE or ISTH clinically relevant non-major bleeding [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
- All-cause or cardiovascular death [Day 1 to 24 months (2 years)]
- Major adverse cardiac event (MACE) [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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over 19 years old
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Patient who underwent PCI with DES 12 months to 18 months ago
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Non-valvular atrial fibrillation patients requiring long-term anticoagulation
Exclusion Criteria:
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Over 85 years old
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Pregnancy or Potential Pregnancy
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Life expectancy within 1 year
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Patients who refuse or do not understand the written consent form
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Requiring anticoagulation due to history of mechanical valve replacement, mitral stenosis or deep vein thrombosis
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Coagulopathy, continuous bleeding, or Hb level below 10 g/dL
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Intracerebral hemorrhage within 2 months
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Patients with gastrointestinal hemorrhage within three months of registration
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Patients diagnosed with a gastrointestinal tumor that requires continuous treatment
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Patients treated with 1st generation drug-eluting stents (Cypher, Taxus, or Endeavor Sprint)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Severance Cardiovascular Hospital, Yonsei University Health System | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Yonsei University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4-2019-1128