Atrial Fibrillation Clinical Trial
— (ADD-ON)Official title:
The Role of Additional Antiplatelet Therapy in the Ischemic Stroke With Atrial Fibrillation and Co-morbiD Atherosclerosis During edOxaban treatmeNt. (ADD-ON) Study, Multicenter Registry-based Analysis
This study aims to compare the effectiveness and safety regarding treatment with standard anticoagulant only or adding antiplatelet to anticoagulant in patients with non-valvular atrial fibrillation and significant atherosclerosis including extracranial, intracranial, coronary or peripheral artery.
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | February 28, 2024 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients with acute cerebral infarction or transient ischemic attack within 14 days of symptom onset based on Last Known Normal Time. 2. Patients with non-valvular atrial fibrillation including paroxysmal atrial fibrillation which is eligible for treatment with Edoxaban. 3. Patients with significant atherosclerosis confirmed by imaging tests on the cerebral arteries, coronary arteries, or peripheral arteries and suitable for the use of antiplatelet agents. - Significant intracranial internal stenosis confirmed by CTA or MRA - A history of coronary artery disease, meaningful findings from CTA or CAG Arterial stenosis - Peripheral arterial disease (Ankle-Brachial Index, ABI <0.9, significant stenosis found in lower limb ultrasonography 3) Men and women over 20 years old 4) Patients who voluntarily agreed to register the registry Exclusion Criteria: 1. Patients with chronic renal failure (GFR <30 ml / min) or severe liver damage 2. patients requiring warfarin medication due to prosthetic valve replacement 3. patients with internal bleeding (active internal bleeding) 4. bleeding diathesis 5. History of acute myocardial infarction or received coronary artery procedure within 6 months before screening 6. Patients who have received or are scheduled to undergo carotid stenting within 1 year 7. Currently, two or more antiplatelet agents are required due to arteriosclerosis. 8. Patients whose survival period is expected to be less than 12 months due to serious diseases such as terminal cancer or liver failure 9. Patients who are scheduled for invasive surgery with possible uncontrolled bleeding, including major surgery 10. Women who are pregnant or lactating, do not have contraception during the study 11. A person who is found to be unsuitable for participation in the study due to the clinical laboratory test results or other reasons |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Asan Medical Center | Chonbuk National University, Chonnam National University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Chungnam National University Hospital, Dongtan Sacred Heart Hospital, Eulji University Hospital, Ewha Womans University, Keimyung University Dongsan Medical Center, Korea University, Korea University Guro Hospital, Kyungpook National University Hospital, Myongji Hospital, Pusan National University Hospital, Samsung Medical Center |
Korea, Republic of,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MACE (major adverse cardiac event) | Duration for first occurrence of major cardiovascular events after patient registration: ischemic stroke, hemorrhagic stroke, myocardial infarction, vascular death | 18 months | |
Secondary | Hemorrhagic stroke | Duration for first occurrence of hemorrhagic stroke after patient registration | 18 months | |
Secondary | Stroke | Duration for first occurrence of stroke (ischemic and hemorrhagic) after patient registration | 18 months | |
Secondary | Acute Myocardial Infarction | Duration for first occurrence of acute myocardial infarction after patient registration | 18 months | |
Secondary | Major bleeding | Duration for occurrence of major bleeding based on ISTH( International Society on Thrombosis and Haemostasis) after patient registration | 18 months | |
Secondary | Vascular death | Duration for first occurrence of vascular death after patient registration | 18 months | |
Secondary | Ischemic stroke | Duration for first occurrence of ischemic stroke after patient registration | 18 months | |
Secondary | Net clinical benefit based on reduction in major adverse cardiac event compared to major bleeding events | Net clinical benefit based on reduction in major adverse cardiac event compared to major bleeding events | 18 months |
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