- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04250116
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jung-Sun Kim
- Phone Number: 82-2-2228-8457
- Email: KJS1218@yuhs.ac
Study Locations
-
-
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Seoul, Korea, Republic of
- Recruiting
- Severance Cardiovascular Hospital, Yonsei University Health System
-
Contact:
- Jung-Sun Kim
- Phone Number: 82-2-2228-8457
- Email: KJS1218@yuhs.ac
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dual antithrombotic therapy
|
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.
|
Experimental: NOAC monotherapy
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
at 12 months (1 year)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Each component of NACE
Time Frame: Day 1 to 12 months (1 year)
|
1) 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
|
Day 1 to 12 months (1 year)
|
ISTH major or clinically relevant non-major bleeding
Time Frame: Day 1 to 12 months (1 year)
|
Day 1 to 12 months (1 year)
|
|
All-cause death, myocardial infarction, stent thrombosis, stroke, systemic embolism, and ISTH major bleeding
Time Frame: Day 1 to 12 months (1 year)
|
Day 1 to 12 months (1 year)
|
|
Cardiovascular death
Time Frame: Day 1 to 12 months (1 year)
|
Day 1 to 12 months (1 year)
|
|
Cardiovascular death, myocardial infarction, stent thrombosis, ischemic stroke, and systemic embolism
Time Frame: Day 1 to 12 months (1 year)
|
Day 1 to 12 months (1 year)
|
|
Primary outcome (NACE) at 2 years
Time Frame: Day 1 to 24 months (2 years)
|
Day 1 to 24 months (2 years)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Clopidogrel
Other Study ID Numbers
- 4-2019-1128
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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